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1. (WO2014159132) SYSTEMS AND METHODS FOR TESTING PATIENT MONITORS
Note: Text based on automatic Optical Character Recognition processes. Please use the PDF version for legal matters

WHAT IS CLAIMED IS:

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 any one of Claims 1 to 3, 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 any one of Claims 1 to 4, comprising an information element.

6. The qualify control system of any one of Claims 1 to 5, wherein the display indicia includes indicia indicating a quality pass or fail.

7. The quality control system of any one of Claims 1 to 6, 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.

8. The quality control system of any one of Claims 1 to 6, wherein the processing by the monitor comprises processing detector signals when the insert is placed in the sensor is different from processing detector signals when tissue is placed in the sensor,

9. The quality control system of any one of Claims 1 to 8, wherein the patient monitor generates an audible indicia indicating a quality pass or fail.

10. The quality control system of any one of Claims 1 to 9, wherein when the insert is properly placed within the sensor and irradiated 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.

11. The quality control system of Claim 10, 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.

12. The quality control system of any one of Claims 1 to 11, wherein when the insert is properly placed within the sensor and irradiated by the sensor, the monitor processes the detector signals, 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.

13. The quality control system of Claim 12, wherein, 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.

14. The qualify control system of any one of Claims 1 to 13, 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.

15. The quality control system of Claim 14, 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.

16. The qualify control system of any one of Claims 1 to 15, wherein when the insert is properly placed within the sensor and attenuates light emitted by the sensor, the monitor processes the defector 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.

17. The quality control system of any one of Claims 1 to 15, 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.

18. The quality control system of any one of Claims 1 to 17, wherein when the insert is properly placed within the sensor, 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.

19. The quality control system of any one of Claims 1 to 17, 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.

20. The quality control system of any one of Claims 18 to 19, 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.

21. The quality control system of any one of Claims 1 to 20, wherein when the insert is properly placed within the sensor, 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.

22. The quality control system of any one of Claims 1 to 20, 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.

23. The quality control system of any one of Claims 21 to 22, 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.

24. The quality control system of any one of Claims 1 to 23, wherein a body of the insert is sized to generally mechanically mate with the surfaces of the optical sensor that is a predetermined size, wherein the predetermined size of the optical sensor varies depending on a size of the body tissue of the patient desired to be inserted into the optical sensor.

25. The quality control system of any one of Claims 1 to 24, wherein the insert has at least one of a color size indicator or a symbol size indicator corresponding to a predetermined size of the insert.

26. The quality control system of any one of Claims 1 to 24, wherein the insert has a predetermined size, and each predetermined size of the body has a same predetermined range of values.

27. The quality control system of Claim 26, wherein the insert has at least one of a color size indicator or a symbol size indicator corresponding to the predetermined size of the insert.

28. 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.

29. The quality control system of Claim 28, wherein the patient monitor generates at least one of a visual indicia or an audible indicia indicating a quality pass or fail.

30. The quality control system of any one of Claims 28 to 29, 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.

31. The quality control system of Claim 30, 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.

32. The quality control system of any one of Claims 28 to 31 , 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.

33. The quality control system of Claim 32, 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.

34. The quality control system of any one of Claims 28 to 33, 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.

35. The quality control system of Claim 34, 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.

36. The quality control system of any one of Claims 28 to 35, wherein when the insert is properly placed within the sensor and attenuates light emitted by the sensor, the monitor processes the detector signal, and wherein the patient monitor determines whether a noise level associated with the detector signals is within a predetermined noise level range of values.

37. The quality control system of any one of Claims 28 to 35, 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.

38. The quality control system of any one of Claims 28 to 37, wherein when the insert is properly placed within the sensor, the patient monitor determines whether values generated by an acceleration signal associated with

an acceleromeier of the sensor are within a predetermined acceleration range of values.

39. The quality control system of any one of Claims 28 to 37, wherein the patient monitor determines whether values generated by an acceleration signal associated with an acceierometer of the sensor are within a predetermined acceleration range of values.

40. The quality control system of any one of Claims 38 to 39, wherein when the sensor is not moved and the values generated by the acceleration signal associated with the acceierometer are not within the predetermined acceleration range of values, the acceierometer is determined to have failed.

41. The quality control system of any one of Claims 28 to 40, wherein when the insert is properly placed within the sensor, 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.

42. The quality control system of any one of Claims 28 to 40, 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.

43. The quality control system of any one of Claims 41 to 42, 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.

44. The quality control system of any one of Claims 28 to 43, wherein the insert has at least one of a color indicator or a symbol indicator corresponding to verification data.

45. The quality control system of Claim 44, wherein the verification data comprises ranges of data.

46. The quality control system of any one of Claims 28 to 45, wherein the optical properties of the insert are at least in part due to light absorbing constituents in the insert.

47. The quality control system of Claim 46, wherein the light absorbing constituents are suspended within a body of the insert,

48. The quality control system of any one of Claims 28 to 47, wherein the insert comprises an information element corresponding to the optical properties, the information element configured to communicate the predetermined transmittance range of values to the monitor.

49. The quality control system of any one of Claims 28 to 48, 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.

50. The quality control system of any one of Claims 28 to 48, wherein the processing by the monitor comprises processing detector signals when the insert is placed in the sensor is different from processing detector signals when tissue is placed in the sensor.

51. The quality control system of any one of Claims 28 to 50, wherein a body of the insert is sized to engage with the surfaces of the optical sensor that is a predetermined size, wherein the predetermined size of the optical sensor varies depending on a size of the body tissue of the patient desired to be inserted into the optical sensor.

52. The quality control system of any one of Claims 28 to 51 , wherein the insert has at least one of a color size indicator or a symbol size indicator corresponding to a predetermined size of the insert.

53. The quality control system of any one of Claims 28 to 51 , wherein the insert has a predetermined size, and each predetermined size of the body has a same predetermined transmittance range of values.

54. The quality control system of Claim 53, wherein the insert has at least one of a color size indicator or a symbol size indicator corresponding to the predetermined size of the insert.

55. 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.

56. The quality control insert of Claim 55, wherein the light absorbing constituents are suspended in the body of the insert.

57. The quality control insert of any one of Claims 55 to 56, 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.

58. The quality control insert of any one of Claims 55 to 56, further comprising bumpers configured to aid in positioning the body in the sensor at a predetermined position.

59. The quality control insert of Claim 58, wherein the bumpers comprise a stop configured to inhibit insertion of the body into the sensor beyond the predetermined position.

60. The quality control insert of any one of Claims 55 to 59, wherein the body comprises an emitter outline for aligning the emitter outline with emitters of the sensor.

61. The quality control insert of any one of Claims 55 to 60, wherein the body comprises an indentation that mirrors a bump of the sensor, the bump housing light defectors of sensor, the indentation mating with the bump when the body is inserted into the sensor at a predetermined position.

62. The quality control insert of any one Claims of 55 to 61 , wherein the body comprises a knob for holding the quality control insert during placement and alignment of the body in the sensor.

63. The quality control insert of any one of Claims 55 to 62, further comprising at least one of a color indicator or a symbol indicator corresponding to the optical properties.

64. The quality control insert of any one of Claims 55 to 63, further comprising an information element corresponding to the optical properties, the information element configured to communicate the predetermined absorption values to the patient monitor.

65. The quality control insert of any one of Claims 55 to 64, wherein the body is sized to be inserted into the optical sensor that is a predetermined size, wherein the predetermined size of the optical sensor varies depending on a size of body tissue of the patient desired to be inserted into the optical sensor.

66. The quality control insert of any one of Claims 55 to 65, further comprising at least one of a color size indicator or a symbol size indicator corresponding to a predetermined size of the body.

67. The quality control insert of Claim 66, wherein each predetermined size of the body has a same range of predetermined light absorption values.

68. The quality control insert of any one of Claims 55 to 65, wherein the body has a predetermined size, and each predetermined size of the body has a same range of predetermined light absorption values.

69. The quality control insert of Claim 68, wherein the light absorbing constituents vary in at least one of type or quantity based on the predetermined size of the body.

70. The quality control insert of any one of Claims 55 to 65, wherein the light absorbing constituents vary in at least one of type or quantity based on a predetermined range of light absorption values.

71 . The quality control insert of Claim 70, further comprising at least one of a color indicator or a symbol indicator corresponding to the predetermined range of light absorption values, wherein the predetermined range of light absorption values corresponds to at least one of a high range or a low range of the light absorption values.

72. A quality control method comprising:

inserting a quality control insert having optical properties into a noninvasive optical sensor of a patient monitor, the sensor configured to detect light attenuated by body tissue of a patient and output detector signals responsive to the detected light, the monitor configured to process the detector signals to determine measurement values for one or more physiological parameters of the patient;

irradiating the insert in the sensor;

detecting light attenuated by the insert;

outputting a detector signal corresponding to the defected light attenuated by the insert; and

processing the detector signal to determine whether the processed detector signal generates values within a predetermined range of values, the predetermined range of values associated with the optical properties of the insert.

73. The method of Claim 72, further comprising generating at least one of a visual indicia or an audible indicia indicating a quality pass or fail,

74. The method of any one of Claims 72 to 73, wherein the insert has at least one of a color indicator or a symbol indicator corresponding to verification data,

75. The method of Claim 74, wherein the verification data comprises ranges of data.

76. The method of any one of Claims 72 to 75, wherein the optical properties of the insert are at least in part due to light absorbing constituents in the insert.

77. The method of Claim 76, wherein the light absorbing constituents are suspended within a body of the insert.

78. The method of any one of Claims 72 to 77, further comprising reading an information element corresponding to the optical properties to communicate the predetermined range of values to the monitor.

79. The method of any one of Claims 72 to 78, 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.

80. The method of any one of Claims 72 to 78, wherein the processing by the monitor comprises processing detector signals when the insert is placed in the sensor is different from processing detector signals when tissue is placed in the sensor,

81. The method of any one of Claims 72 to 80, further comprising determining 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.

82. The method of Claim 81 , 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.

83. The method of any one of Claims 72 to 82, further comprising determining whether a gain level of the defector signals to generate a desired level of signal intensity is within a predetermined gain range of values.

84. The method of Claim 76, 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.

85. The method of any one of Claims 72 to 84, further comprising determining whether a rotation frequency of an active pulse motor of the sensor is within a predetermined frequency range of values.

86. The method of Claim 78, 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.

87. The method of any one of Claims 72 to 86, further comprising determining whether a noise level associated with the detector signals is within a predetermined noise level range of values.

88. The method of any one of Claims 72 to 87, further comprising determining whether values generated by an acceleration signal associated with an accelerometer of the sensor are within a predetermined acceleration range of values.

89. The method of Claim 88, 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.

90. The method of any one of Claims 72 to 89, further comprising determining whether values generated by a temperature signal associated with a temperature sensor of the sensor are within a predetermined temperature range of values.

91. The method of Claim 90, 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.

92. The method of any one of Claims 72 to 91 , further comprising choosing a size of the quality control insert to insert into the optical sensor that is a predetermined size, wherein the predetermined size of the optical sensor varies depending on a size of the body tissue of the patient desired to be inserted into the optical sensor.

93. The method of Claim 92, wherein the choosing of the size of the quality control insert is based on at least one of a color size indicator or a symbol size indicator corresponding to a predetermined size of the insert corresponding to the predetermined size of the optical sensor.

94. The method of Claim 92, wherein each size of the insert has a same predetermined transmittance range of values.

95. The method of Claim 94, wherein the insert has at least one of a color size indicator or a symbol size indicator corresponding to the size of the insert.

96. A quality control kit comprising:

a plurality of quality control inserts, each insert comprising light absorbing constituents having predetermined optical properties, each insert 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 predetermined optical properties are associated with the light absorbing constituents attenuating light at predetermined light absorption values based on wavelengths of the light when the insert is irradiated by the sensor.

97. The kit of Claim 96, wherein each insert is sized to be inserted into a predetermined size sensor, wherein the predetermined size sensor varies depending on a size of body tissue of the patient desired to be inserted into the sensor.

98. The kit of any one of Claims 96 to 97, wherein each insert has at least one of a color size indicator or a symbol size indicator corresponding to a predetermined size of the insert.

99. The kit of any one of Claims 96 to 98, wherein the light absorbing constituents of each insert vary in at least one of type or quantity based on a predetermined range of light absorption values.

100. The kit of Claim 99, wherein each insert has at least one of a color indicator or a symbol indicator corresponding to the predetermined range of light absorption values, wherein the predetermined range of light absorption values corresponds to at least one of a high range or a low range of the light absorption values.

101 . The kit of any one of Claims 96 to 99, wherein each insert has a same predetermined range of light absorption values.