The present disclosure relates generally to medical monitors and, more particularly, to certification of computers that are used in conjunction with medical devices.
This section is intended to introduce the reader to various aspects of art that may be related to various aspects of the present disclosure, which are described and/or claimed below. This discussion is believed to be helpful in providing the reader with background information to facilitate a better understanding of the various aspects of the present disclosure. Accordingly, it should be understood that these statements are to be read in this light, and not as admissions of prior art.
In the field of healthcare, caregivers (e.g., doctors and other healthcare professionals) often desire to monitor certain physiological characteristics of their patients. Accordingly, a wide variety of devices have been developed for monitoring many such characteristics of a patient. Such devices provide doctors and other healthcare personnel with the information they need to provide the best possible healthcare for their patients. As a result, such monitoring devices have become an indispensable part of modern medicine.
Monitoring devices are often configured as dedicated monitoring units (e.g., a stand-alone pulse oximetry monitor) with integral processing circuitry for receiving measurements from medical devices and converting these measurements into medical information that is meaningful to a clinician. However, certain types of medical devices are capable of being used with configurable personal computers that are loaded with software that communicates with the medical device. For example, a medical sensor may be capable of communicating directly with a personal computer, which, with the appropriate software, is able to receive the sensor measurements and process and display information related to the sensed data. In this manner, an off-the shelf computer may act as a medical monitor.
In contrast to dedicated monitoring devices, which are limited-purpose machines, a personal computer (e.g., a general purpose computer) may be used for a variety of tasks and, as such, may run a variety of different software programs. Different end users may select different brands and/or computer models depending on their own needs. Accordingly, different types of computers may have differing levels of compatibility with particular medical devices. Further, an individual computer may be frequently upgraded or changed from its factory condition according to the needs of the user, and these updates often occur automatically in response software or operating system changes. In certain instances, these changes may cause certain incompatibilities with installed software for receiving medical device information.
Advantages of the disclosed techniques may become apparent upon reading the following detailed description and upon reference to the drawings in which:
One or more embodiments of the present techniques will be described below. In an effort to provide a concise description of these embodiments, not all features of an actual implementation are described in the specification. It should be appreciated that in the development of any such actual implementation, as in any engineering or design project, numerous implementation-specific decisions must be made to achieve the developers' specific goals, such as compliance with system-related and business-related constraints, which may vary from one implementation to another. Moreover, it should be appreciated that such a development effort might be complex and time consuming, but would nevertheless be a routine undertaking of design, fabrication, and manufacture for those of ordinary skill having the benefit of this disclosure.
Medical monitors are built according to FDA or other regulatory specifications and undergo quality testing by the manufacturer. However, in the case of medical devices that may be used with personal or off-the-shelf computers, while the medical devices themselves are subjected to quality testing by the manufacturer, the computers may be purchased by an end user and, thus, are not necessarily tested by the medical device manufacturer for compatibility with the medical device. In such cases, a particular model of computer may be certified by a technician as being compatible with a particular type of medical device and the device's associated software for processing data or measurements. This certification may involve having a technician run diagnostic tests on an individual model of a computer to verify that the device and installed software are compatible and that accurate readings and data processing are performed. Such certifications are time-consuming and involve skilled personnel. In addition, the certification must be repeated for different brands and different models of computers. Because computer vendors frequently change their offerings as technology changes and improves, a particular computer model that has been certified for use with a particular medical device may become obsolete and no longer available on the market. In addition, end users may change the functionality of their own computers, which may introduce device incompatibilities.
Provided herein is an automatic certification technique for a computer configured to be used in conjunction with a medical device. In addition, provided herein are systems and computers that include certification functionality (e.g., a certification module). The certification may involve using the computer to process stored data representative of data collected by the medical device and comparing the processed results to an expected result. In this manner, the computer may be certified as performing according to expectations. In certain embodiments, the certification module as well as the data representative of the medical device may be installed directly on the computer (e.g., bundled with software for receiving and processing the medical device signal) so that the certification may take place without any outside input from the medical device. In other embodiments, an input from an associated device may trigger the certification process.
It should be understood that the certification techniques may be used in conjunction with medical devices for diagnosis and/or therapy. Such devices may include devices for sensing physiological parameters, collecting medical data (e.g., imaging data), delivering therapy, and performing procedures. The devices may include blood or tissue constituent sensors (e.g., pulse oximetry sensors, carbon dioxide sensors, or aquametry sensors), patient temperature sensors, transvascular fluid exchange sensors, blood flow, cardiovascular effort, glucose levels, total hematocrit, electrocardiography, electroencephalograpy, airway products and ventilation devices, infusion pumps, blood pressure devices, apnea masks, ultrasound transducers, and cardiac defibrillators. In addition, the certification techniques may be used with computers having installed software for receiving and processing signals from a medical device to generate medical information. Such computers may include personal computers, off-the-shelf computers, multi-purpose computers, laptops, desktop computers, notebooks, mobile communication devices, or any suitable computing device.
Turning now to the figures,
According to a particular embodiment, instructions for certification stored on the computer 12 access stored data that is representative of data generated by the medical device 14 at step 44. It is envisioned that, in the depicted embodiment, the stored data may be stored in computer memory 20 or a portable memory device (e.g., a flash memory device). Accordingly, the stored data may be accessed when the computer 12 is not coupled to the medical device 14. The certification instructions may be part of medical device software for receiving signals from the medical device 14 and generating medical information. In particular implementations, installation of the medical device software is accompanied by executing the method 40 to complete the installation. For example, the installation and/or certification may be performed by an end user. In other embodiments, the installation and certification may be performed by a vendor of the software and medical device. The vendor may purchase an off-the-shelf computer, install the software, and initiate the steps of the method 40 to certify the computer 12. In other embodiments, the certification process 40 may begin upon computer startup or when the medical device software is accessed. That is, regardless of whether the initial certification was initiated by a vendor or the end user, additional certifications may be completed during the operation of the computer 12.
At step 46, the stored data is processed according to the instructions installed on the computer 12 for processing incoming signals from the medical device 14. The processed output of the medical device operating software is compared to an expected result at step 48. At decision step 49, if the processed output is within an acceptable deviation from the expected result, the method 40 proceeds to step 50, and the computer is certified to be used with the medical device 14. If the processed output is outside of an acceptable deviation from the expected result, the method 40 proceeds to step 52, and the computer is not certified or is rejected. Optionally, the method 40 may prevent incoming signals from the medical device 14 and/or coupling of the medical device 14 to the computer 12 if the computer 12 is rejected. In other embodiments, the medical device software may be prevented from completing installation if the computer 12 is rejected.
The stored data is representative of a typical medical device output when the medical device 14 is in operation (e.g., coupled to a patient). In particular embodiments, the stored data may be historical data that has been collected (e.g., recorded or stored) from a test device and that provides sufficient information for generating medical information about a patient. A test device may be a version of the medical device 14 that has been verified to generate a representative signal for a particular physiological parameter or other medical data. In other embodiments, the stored data may be simulated data that simulates the incoming signal of the medical device 14. By using data from a test device or simulated data, the certification process may provide information about the functionality of the computer 12 and its installed software that is isolated from any variations or irregularities in a particular medical device 14. That is, because the stored data is not generated by the medical device 14 itself, the certification may be specific to the computer 12. In other implementations, it may be advantageous to provide stored data that has been collected by the medical device 14 in question. For example, if the medical device 14 has been customized for a particular end use, the stored data may be generated from the medical device 14 for use in certification.
In certain embodiments, the medical device 14 may be configured to generate an analog signal or a digital signal that is further processed via hardware and/or software to condition the signal and generate an output representative of medical information. For example, if the medical device 14 is a temperature sensor, the stored data representative of the medical device signal may be stored in the form of an analog signal in which the voltage varies according to the sensed temperature. In other embodiments, the data representative of an analog signal may be converted to a digital signal, and the certification process may include a digital-to-analog conversion step. The analog signal or digital signal may be processed according to instructions encoded in the installed software, which may include correlating particular voltages to particular temperature readings and providing an indication of the sensed temperatures. The calculated temperatures may be compared to the expected results, e.g., results from a test run or results that were independently confirmed, to determine if the computer 12 is compatible with the medical device 14. If the calculated temperatures deviate from the expected temperatures by less than a predetermined amount (e.g., less than a standard deviation), the computer 12 may be certified.
Certification or rejection of the computer 12 may trigger one or more audible or visual indicators. For example, the display of an indicator or text message may be triggered upon certification of the computer 12. The indicator may be a green light, a check mark, and/or a message that refers to successful certification. Rejection of the computer 12 (e.g., a failure to be certified) may trigger an alarm, a red light, a message related to unsuccessful certification, and/or an inability to open or access the medical device software.
The certification information may be provided to a regulatory agency, such as the Food and Drug Administration (FDA), as part of the certification process. Computer certification, such as certification via method 40, may be provided as part of the guidelines for approval of the medical device 14. In addition, all or part of a certification process may form part of text-based instructions or other training materials for the medical device 14. The device manufacturer may designate particular computer hardware specifications, including processor specifications, (manufacturer, speed, and features), RAM (memory size), hard disk size, other storage, communications, display, etc., and software specifications, such as operating system, drivers, utilities, etc as being compatible with the medical device software in question. These specifications may be provided as part of a software requirements specifications (SRS) document. As part of this or other submitted documentation for approval, the device manufacturer may specify how the use of the medical device software by an end user may be regulated or monitored, including any certification of the computer 12 to be used with the medical device 14. For example, the specifications may include guidelines for the frequency of the certification, such as every time the computer 12 is booted or after every update to the computer 12. In one embodiment, installation of new software or computer updates will trigger certification, such as via method 40, either automatically or through a pop-up window or reminder on the computer display
Certification information for the computer 12 may be automatically provided to the FDA, or may be stored in the computer's memory 20 for later review or submission.
In a specific embodiment, the certification techniques may be used in conjunction with a pulse oximetry system.
The sensor drive 84 may include a time processing unit (TPU) to provide timing control signals to light drive circuitry, which controls when the optical components of the sensor 64, such as light emitter 88 and light detector 90, are activated, and, if multiple light sources are used, the multiplexed timing for the different light sources. The sensor drive 84 may also control the gating-in of signals from sensor 64 through one or more switching circuits. The received signal from the pulse oximetry sensor 64 may be passed to the oximetry module 80, which may include one or more signal conditioning elements that may be hardware or software-enabled, including an amplifier, a low pass filter, and an analog-to-digital converter. Based at least in part upon the received signals, the oximetry module 80 may calculate the oxygen saturation and/or heart rate using various algorithms, such as those employed by the Nellcor™ N-600x™ pulse oximetry monitor, which may be used in conjunction with various Nellcor™ pulse oximetry sensors, such as OxiMax™ sensors. These algorithms may employ certain coefficients, which may be empirically determined, and may correspond to the wavelengths of light used. In one embodiment, the correction coefficients may be provided as a lookup table.
In the depicted embodiment, a memory element 94 associated with the sensor 64 is configured to store certain information that is accessed by the certification module 82, such as stored data representative of output by the detector 90. The memory element 94 may also store calibration and identification information, including compatibility information for the computer 12. For example, the memory element 94 may store compatible medical device software version information that may be accessed by the calibration module 82 as part of the certification process. The memory element 94 may be associated with the sensor body, the cable 66, or the connector 68. In other embodiments, data representative of detector output may be stored on the computer 12 as part of the certification module 82.
The computer 12 is capable of reading the information from the memory element 94 to as part of the certification process.
The computer 12 reads the initialization requirements based on information stored in the memory element 94 at step 106 to determine if the computer 12 passes an initialization test at step 108. The initialization requirements may include software and sensor compatibility requirements (e.g., if the sensor is from a manufacturer that is supported by the software), software and hardware specifications, and software version specifications. The stored information may include explicit initialization information, or may include identification information for the sensor that may be further analyzed by the certification module 82 to determine compatibility. If the computer 12 is not compatible with the medical device (e.g., sensor 64), the computer 12 is rejected at step 110. If the computer 12 passes the initialization requirements, the method 100 moves to step 112 to read simulated data stored on the memory element 94. The simulated data may be processed by the oximetry module 80 at step 114 and the results compared with expected results at step 116. If the results do not match, the computer is rejected at step 120. If the results match expected results, the computer 12 is certified and the software may continue operating at step 122. An indication of successful certification may be provided at step 124.
The embodiments described above have been shown by way of example, and it should be understood that these embodiments may be susceptible to various modifications and alternative forms. It should be further understood that the claims are not intended to be limited to the particular forms disclosed, but rather to cover all modifications, equivalents, and alternatives falling within the spirit and scope of this disclosure.
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