PORTABLE MONITORING SYSTEM

专利摘要:
sample collection and bioluminescent analysis system methods and apparatus for assessing the quality of an environment or process by measuring light emitted from a bioluminescent sample containing atp, adp or alkaline phosphatase. The device comprises a sample collection and analysis system used to collect a sample, mix reagents, react the sample, and collect it in a measuring chamber. the system includes an instrument having a photon detection assembly for use with the sample test device and one or more probe assemblies that optically cooperate with the instrument. the instrument includes a darkroom with a reflective interior surface that can be concave or preferably spherical, and a photon detection sensor like a multi-pixel photon counter sensor. a substantially transparent portion of the probe assembly, and liquid contained therein, focuses on bioluminescence towards the photon detection sensor.
公开号:BR112014032930B1
申请号:R112014032930-3
申请日:2013-03-05
公开日:2021-04-13
发明作者:Marc Warren Gordon；Jon Keith Perrin；Alexander Michael Diener；David Oscar Iverson；Kyle Stuart Johnson；Garet Glenn Nenninger；John Russell Murkowski；Kristin Marie Will；Chad Austin Brinckerhoff；Phillip T. Feldsine；Tim Allen Kelly
申请人:Biocontrol Systems, Inc；
IPC主号:

专利说明:

BACKGROUND FIELD
[001] The revelation is related to the field of environmental testing; for example, testing of food, materials, surfaces, and / or equipment, for example, surfaces or equipment with which the food comes into contact during preparation or processing. DESCRIPTION OF RELATED TECHNIQUE
[002] Safety in the food industry is of growing concern. In recent years, approaches to monitor and control contamination and hygiene have increasingly used the HACCP (Critical Control Point and Hazard Analysis) principles. Such approaches are not only aimed at controlling the occurrence of pathogenic microorganisms, but are also aimed at avoiding hazards before those hazards become widespread and expensive problems. HACCP is the internationally accepted science-based system for ensuring food safety. HACCP has been adopted by the FDA and USDA as well as by other countries. HACCP has been endorsed by the National Academy of Sciences, the Codex Alimentarius Commission (an international food standard setting organization), and the National Advisory Committee on Microbiological Criteria for Foods. Developed for more than 40 years for the space program, HACCP has proven to be effective in ensuring that food safety risks are controlled to prevent unsafe food from reaching the consumer.
[003] In the United States alone, since 1995, HACCP-based systems have been mandatory for the following industries by the Federal Government:
[004]. Seafood - (21 C.F.R. Parts 123 and 1240 Procedures for the Safe and Sanitary Processing and Importing of Fish and Fishery Products; Final rule) in December 1995.
[005] Carme and birds - (9 C.F.R. Part 304, and others, Pathogen Reduction: Hazard Analysis and critical control point (HACCP) systems; Final rule) in July 1996.
[006] Fruit and vegetable juice - (21 C.F.R. Part 120: Hazard Analysis and Critical Control Point (HACCP); Procedures for the Safe and sanitary Processing and Importing of juice; Final rule) in January 2001.
[007] Trust in HACCP will continue for the foreseeable future.
[008] For a food manufacturer or handler to effectively comply with HACCP-based standards or requirements, it is vital that the food manufacturer or handler has an effective system in place to collect, monitor and analyze relevant HACCP data. The need for this can be seen by examining the seven HACCP principles required for compliance:
[009] 1. Conduct a risk analysis.
[010] 2. Determine the critical control points (CCP). A CCP is a point, step or procedure in a food process where a number of possible measurement controls can be applied and, as a result, a risk to food safety can be avoided, eliminated, or reduced to acceptable levels.
[011] 3. Establish measurement parameters and critical limits for each CCP and identify methods for measuring the CCP. For example, compliance with a cooking CCP can be assessed by combining two indicators: time and temperature.
[012] 4. Monitor the CCP to ensure continuous compliance with established critical limits. A monitoring system should not only detect individual deviations, but also analyze data to identify patterns of deviation that could indicate a need to reevaluate the HACCP plan.
[013] 4. Establishing corrective actions to be taken during monitoring of important parameters shows that a critical limit has not been met.
[014] Keep accurate records. Keeping an effective record is a requirement. HACCP records must be created at the time the events occur and include parameter measurement, date, time and the plant employee making the launch.
[015] 7. Check that the system is functioning properly and initially as well as continuously. These activities include calibration of the monitoring equipment, direct observations of the monitoring activities and an examination of the records.
[016] An essential feature of the HACCP system that differentiates it from previous inspection system (s) is that it places the responsibility for food safety directly on the food handler or manufacturer. Each processor or food handler must be able to identify CCPs, measure a variety of parametric indicators for each CCP (for example, temperature and time measurements to verify cooking process), identify deviations, perform deviation trend analysis, and document the data to show compliance with HACCP requirements.
[017] It is not surprising that the growing reach of HACCP-based systems is progressing simultaneously with a trend towards testing methods that are refined because they are faster, more sensitive and easier to perform. Stricter standards, such as those associated with HACCP-based systems, are expected to motivate such improvements in test methods. The reverse is also true in that as testing methods improve, standards are likely to become more stringent, as compliance can be more accurately, precisely and efficiently maintained and verified.
[018] This trend towards improved testing is occurring in a wide variety of industries, including, but not limited to, those related to the areas of food, pharmaceuticals, cosmetics and medical. In such industries, many techniques are used to monitor levels of environmental quality, including techniques that use microbiological cultures. Microbiological cultures are a more widely performed test method, but due to their low test throughput capacity and long periods of incubation time, they are of limited use. They cannot measure the quality of the environment immediately before the start of an operation. A variety of tests have been developed that detect and in some cases quantify specific pathogens. They can range from automated high throughput systems to single sample test devices. These methods require the growth of microorganisms for detection, which takes considerable time. Monitoring levels of adenosine triphosphate (ATP), adenosine diphosphate (ADP) and alkaline phosphate (AP), make use of parameters that indirectly correlate with the level or degree of environmental contamination. Still others monitor factors related to the risk of the presence and spread of microorganisms, that is, temperature, pH, conductivity and protein residues. The types of methods mentioned last are usually in real time in their determinations, offering a distinct advantage for the user to obtain critical environmental quality information on an immediate basis.
[019] Typically, bioluminescent techniques are used to detect the presence of ATP and AP and similar targets. The protocol involves using a device (for example, swab) to collect a sample from a surface of interest, and activating the device to mix reagents together with the sample to produce light proportional to the amount of ATP / AP sampled. The reaction is then read by inserting the device into a photon measuring instrument.
[020] A bioluminescent ATP monitoring system is the LIGHTNING system developed by IDEXX LABORATORIES. The device contains a pre-moistened cotton swab, plug in a bulb at one end and freeze-dried reagent in a foil-sealed compartment at the reading end. The swab is removed from the device, used to collect a sample from a test surface, and returned to the device tube. The bulb is then flexed to break and open a pressure valve, which releases the plug into the reading chamber when the bulb is tightened. The swab containing sampled is then pushed through a sheet barrier, the device is shaken and the reaction proceeds between ATP in the swab and the dissolved reagent (in the buffer). The device is inserted into the reading chamber of the photon measuring instrument and a reading is made during an integration period of ten seconds. The intensity of the bio-luminescent signal is proportional to ATP in the swab.
[021] Another system is called the CHARM SCIENCES POCKETSWAB PLUS. It is an integrated device used with a portable LUMINATOR T luminometer. The device contains a pre-moistened cotton swab. It is removed from the base of the device, used to clean a surface, returned to the base, then activated by screwing the relative upper portion into the base. This action causes the tip of the cuff to perforate separation barriers allowing separate reagents to migrate to the lower chamber of the base, mixing and reacting with the sample collected in the swab. Stirring is required to facilitate transfer of reagent to the bottom and mixing in the lower chamber. The activated device is then inserted into a hole in the top of the luminometer and pushed down until it finds a stop. This process dislocates a door. The upper portion of the device remains outside the instrument, but forms a seal with the reading chamber hole. A read button on the instrument is then pressed to start a signal integration period before a reading is displayed in relative light units (RLU).
[022] Another such system is the independent device BIOTRACE CLEANTRACE RAPID CLEANLINESS TEST for use with the UNI-LITE XCEL portable luminometer. There is also a pre-moistened swab, which is removed, a sample is collected, and the swab is returned. Activation involves forcing the upper portion of the device, containing the sample, down into the base, through the membrane barriers. The swab engages a perforation tip, which breaks the membranes and allows the reagents to mix in a manner similar to that of the CHARM device. Stirring is required to transfer the entire solution to the bottom. The BIOTRACE luminometer has a cover, which lifts and rotates out of the way to expose the reading chamber. The sample-containing device is lowered into the chamber and the lid is closed. The total closure of the lid opens a light blocking element to allow signal measurement. Like the CHARM unit, a button starts the reading cycle, which ends with the light reading display in RLUs.
[023] MERCK also offers another hygiene monitoring system for ATP which is the HY-LITE Monitor by MERCK which employs HY-LITE test swabs, rinse tubes and sampling pens. The swab is moistened in the rinse tube. A surface is clean. The swab is returned to the tube and rotated for several seconds to release any collected ATP. The swab is compressed out and removed. Then, the pen is inserted for a second to take the sample. The tip of the pen is tapped on a hard block to engage the cuvette. A button is pushed to release the reagents and start the reaction in the cuvette. The cuvette is then removed and agitated, inserted into the monitor's reading chamber, and a button is pressed to initiate a ten-second light integration period. RLUs are then displayed on the monitor screen.
[024] A similar system was developed by CELSIS called the SYSTEMSURE portable hygiene monitoring system. The test sequence is similar to that of the MERCK system where the swab is moistened and the surface is cleaned. The reagent is then pipetted into the cuvette. The swab is inserted into the cuvette and rotated for several seconds, then removed. The cuvette is capped and inserted in the luminometer, where the reading starts.
[025] There is a need for an improved method and apparatus that are designed to increase ease of use and improve measurement accuracy. Many of the current systems incorporate unnecessary actions by operators that are uncomfortable with certain steps such as pre-wetting, pipetting, rotation, two-hand screwing, two-hand pushing, tapping, shaking and precise timing, which do not adequately control the activation of the device and contribute to increased reading variances. Many of today's systems are slow to operate and may not be able to produce highly accurate results. Such systems can also consume a relatively large amount of electrical energy, so they may not be suitable for convenient mobile use.
[026] This application describes various methods and devices that can address limitations of demanding systems. <HEAD>> SUMMARY
[027] This request is addressed to various modalities of a sample collection and analysis system. The system comprises a sample collection and analysis instrument and sample or probe holder that contains disposable test swabs that, when used together, are capable of efficiently, precisely and accurately monitoring, quantifying, recording and tracking biological contamination in a process or environment using the bioluminescent properties of biological materials collected through test swabs. The instrument comprises a photon detection assembly (for example, multi-pixel photon counter) to measure bioluminescence. The photon detection assembly is communicatively coupled to a control system (eg, logic panels) with a controller (eg, microprocessor, digital signal processor, application specific integrated circuit, programmable port layout, logic controller programmed), readable storage media on a processor or non-transitory computer (for example, volatile memory, non-volatile memory, read-only memory, random access memory), and user interface (UI). The UI provides an intuitive operator interface, easy to use, for example, through a graphical user interface (GUI). A test swab is used to obtain an environmental sample of known volume and then placed in a probe assembly including one or more reagents that extract ATP from any cells present in the environmental sample. The bioluminescence detected from the sample indicates biological contamination and provides a qualitative indication of the level of biological contamination present in the test swab. The system provides an independent, integrated test device for sample collection and luminescence reading using the photon detection assembly. Various modalities of methods to employ the modalities of the instrument and assembly of a probe or sample holder are also subjects of the present application.
[028] The instrument can operate as a luminometer to take light readings from samples contained in the probe or sample holder assembly. A unique darkroom assembly design increases or intensifies the detection of light emitted by samples, providing higher accuracy in results. An exclusive probe design can cooperate synergistically with the darkroom assembly design to further enhance optical sample analysis and result accuracy. Several safety features that prevent or inhibit the use of non-conforming sample holders or probe assemblies with the instrument ensure that a synergistic effect is achieved. The configuration of the sample holder or probe assembly and the way in which the sample holder or probe assembly is sealed in the darkroom assembly prevents the photon detection assembly or photo-responsive sensor from being exposed to external photons . This is important for signal stability and for reducing background photon counts, which is a major source of decreased system sensitivity. The design also minimizes other possible sources of thermal and / or electrical noise.
[029] The instrument may include one or more communication ports that allow the instrument to communicate with one or more external devices, for example, a networked computer. Such ports can be wired or wireless ports, and allow the export of analytical data collected by and stored in a non-transitory memory on the instrument. Such ports also allow the import of software and / or firmware updates of the instrument, for example, as downloadable files from a website.
[030] The instrument can provide an intuitive graphical user interface (GUI), making it easier to use. The instrument employs a portable device format, with a relatively low power consumption to allow convenient use in busy environments without constantly needing to be recharged.
[031] The probe or sample holder assembly, in one embodiment, may include a reagent chamber that can be positioned to rupture or otherwise violate and release one or more reagents contained therein into a fluid conduit of the probe assembly. The reagents reagent with any biological material present in the test swab. Reagents can, for example, be stored in a sealed containment chamber or reservoir that is ruptured or breached by forcing the chamber on a drill tip. The reagent solution flows through a swab tip containing sample, causing the sample to be released into the reagent. The reagent then reacts with the sample and emits light proportional to the level of environmental contamination, by, but not limited to, such materials as ATP, ADP or alkaline phosphatase in the sample, and the reagent chosen for the specific application. A distal end portion of the sample holder or probe mount can be directly inserted into the darkroom mount to measure photons emitted from a bioluminescent sample. BRIEF DESCRIPTION OF THE VARIOUS VIEWS OF THE DRAWINGS
[032] Figures 1A and 1B are respectively a perspective view and a side plan view of an example sample collection and analysis instrument having an ergonomic size, shape and profile that allow the instrument to be safely held with a single hand in accordance with an illustrated embodiment described here; along with a portion of a user interface allowing a user to interact as an instrument, for example, via a touch sensitive or touch responsive input / output device.
[033] Figures 2A and 2B are respectively a perspective view and a side plan view of an example sample collection and analysis instrument having an ergonomic size, shape and profile according to another illustrated embodiment described here; along with a portion of a user interface that allows a user to interact with the instrument, for example, via a touch sensitive or touch responsive input / output device.
[034] Figures 3A and 3B are respectively a perspective view and a side plan view of an example sample collection and analysis instrument having an ergonomic size, shape and profile in accordance with yet another illustrated embodiment described here; along with a user interface allowing a user to interact with the instrument, for example, via a touch-sensitive or touch-responsive input / output device.
[035] Figure 4 is a perspective view of an example sample collection and analysis instrument having an ergonomic size, shape and profile in accordance with yet another illustrated modality described here; along with a user interface allowing a user to interact with the system controller, for example, via a touch sensitive or touch responsive input / output device.
[036] Figure 5 is a perspective view of an example user interface and logic panel assembly of a sample collection and analysis instrument; the user interface can include one or more input systems, such as a touch sensitive or responsive display, allowing a user to interact with a system controller, to store and retrieve data from a system memory, and to communicate with one or more external devices, according to an illustrated embodiment described here.
[037] Figure 6 is a partial section view of an example sample collection and analysis instrument showing a darkroom assembly including a passageway for receiving a sample holder or probe assembly, and ending in a chamber dark that is physically and optically coupled to a photon detection assembly used to measure and quantify the bioluminescence produced by a sample in the darkroom, according to an illustrated embodiment described here.
[038] Figure 7 is a perspective view of an example darkroom assembly including a passage for receiving a sample holder or probe assembly, and ending in a darkroom that is physically and optically coupled to a photon detection assembly used to measure and quantify the photons emitted by the bioluminescence of a sample in the darkroom, according to an illustrated modality described here.
[039] Figure 8A is an isometric view of a swab being used to collect a sample or specimen from an uncleaned surface with the swab, according to an illustrated embodiment.
[040] Figure 8B is a sectional view of an example sample holder in the form of a probe assembly that is part of a sample collection and analysis system together with the instrument, the sample holder or probe assembly having a conduit that is used to contain a test swab containing a sample for analysis from an optically transparent chamber in an extreme distal portion that allows detection of photons emitted by a bio-luminescent sample by the photon detection assembly, and a or more reagent chambers containing one or more reagents useful in causing one or more biological materials that may be present in the liquid sample for bioluminescence, according to an illustrated embodiment described here.
[041] Figure 8C is a cross-sectional diagram of a portion of the sample holder or probe assembly, illustrating a non-circular cross-section profile of an outer surface and a circular cross-section profile of an inner surface that forms a conduit in which a cotton swab is receivable, according to an illustrated modality.
[042] Figure 8D is a cross-sectional diagram of a portion of the sample holder or probe assembly with a plunger thereof in a disengaged position or condition, before violating any reservoirs or chambers, according to an illustrated embodiment.
[043] Figure 8E is a cross-sectional diagram of a portion of the sample holder or probe assembly with a plunger thereof in an engaged position or condition, violating reservoirs or chambers to release their contents, according to a illustrated mode.
[044] Figure 9 is a partially sectioned perspective view of an example darkroom assembly and photon detection assembly, the darkroom assembly including an intermediate tube, a spring, and a darkroom, according to an illustrated embodiment described here.
[045] Figure 10 is a perspective view in section of a photon detection assembly, an example darkroom assembly, a probe or sample holder assembly, and a cover of a cover assembly, the assembly of probe or sample holder at least partially inserted in a passage of the darkroom assembly; the cover in use closes an opening or entrance to the passage of the darkroom assembly and applies sufficient force to compress a spring to properly position the sample holder or probe assembly with a transparent distal portion thereof located in the darkroom. according to an illustrated embodiment described here.
[046] Figure 11 is another perspective view in section of the photon detection assembly, the example darkroom assembly, the probe or specimen holder assembly, and the cover of figure 10, which better illustrates one or more supports darkroom and intermediate chamber that position the probe or sample holder assembly laterally and axially in the passage of the darkroom assembly, according to an illustrated embodiment described here.
[047] Figure 12 is an enlarged perspective view of the photon detection assembly, lower portion of the example darkroom assembly, and lower portion of the specimen holder or probe assembly of figures 10 and 11, better illustrating a portion optically transparent of the sample holder or probe assembly positioned close to the photon detection assembly, as well as a spatial relationship between the darkroom assembly, the distal end of the sample holder or probe assembly and the photon detection assembly, according to an illustrated embodiment described here.
[048] Figure 13A is a side elevation view of an example probe assembly positioned in a spherical darkroom and a multi-pixel photon counter, according to an illustrated embodiment described here.
[049] Figure 13B is a partial section view of a portion of the spherical darkroom, showing a molded plastic base, a coating, layer or reflective material on a concave spherical portion of it, and a coating, layer or material of oxide in the reflective coating, according to an illustrated embodiment described here.
[050] Figure 14A is a top plan view of an example electronic scanning device useful in verifying and authenticating electronically encoded probe assemblies, according to an illustrated embodiment described here.
[051] Figure 14B is a top plan view of an example electronic scanning device useful in verifying and authenticating electronically encoded probe assemblies, according to another illustrated embodiment described here.
[052] Figure 15A is a perspective view of an example optical scanning device useful in verifying and authenticating optically encoded probe assemblies, for example, probe assemblies containing one or more authenticators, according to an embodiment illustrated described here.
[053] Figure 15B is a top plan view of a trademark or trade name of an authenticator, loaded on a sample holder or probe assembly, according to an illustrated embodiment described here.
[054] Figure 16 is a perspective view of an example infrared scanning device useful in verifying and authenticating infrared coded probe assemblies, for example, probe assemblies containing one or more sensitive infrared designs, machine readable codes, or trademark logos, according to an illustrated modality described here.
[055] Figure 17 is a detailed view of an example sample collection and analysis system including an ergonomically shaped and dimensioned instrument and a sample holder or probe assembly, according to an illustrated embodiment described here.
[056] Figure 18 is a screen print of a selection test point through the scrolling screen of a graphical user interface according to an illustrated modality, which can be presented through a processor on a display, for example , a touch-sensitive or touch-responsive display of a portable monitoring instrument like those described above.
[057] Figure 19 is a screen impression of a selection test point through the input screen of a graphical user interface according to an illustrated modality, which can be presented through a processor on a display, for example , a touch-sensitive or touch-responsive display, of a portable monitoring instrument like those described above.
[058] Figure 20 is a screen print of a test results screen from a user interface showing a pass-through to a test zone according to an illustrated modality, which can be displayed through a processor in a display, for example, a touch-sensitive or touch-responsive display, of a portable monitoring instrument such as those described above.
[059] Figure 21 is a screen print of a test results screen from a user interface showing an alert result for a test zone according to an illustrated modality, which can be displayed through a processor in a display, for example, a touch-sensitive or touch-responsive display, of a portable monitoring instrument such as those described above.
[060] Figure 22 is a screen print of a test results screen from a user interface showing a failure result for a test zone according to an illustrated modality, which can be displayed through a processor in a display, for example, a touch-sensitive or touch-responsive display, of a portable monitoring instrument such as those described above.
[061] Figure 23 is a screen print of an instrument panel screen of a user interface according to an illustrated modality, which can be presented on a display through a computer system processor, communicatively coupled to a portable monitoring instrument like those described above.
[062] Figure 24 is a screen print of a screen of raw data from a user interface according to an illustrated modality, which can be presented on a display through a processor of a computer system, communicatively coupled to a portable monitoring instrument such as those described above.
[063] Figure 25 is a screen impression of a test point configuration screen of a user interface according to an illustrated modality, which can be presented on a display through a computer system processor, communicatively. coupled with a portable monitoring instrument such as those described above.
[064] Figure 26 is a screen print of a new test point configuration screen for a user interface according to an illustrated modality, which can be presented on a display through a computer system processor, communicatively coupled to a portable monitoring instrument such as those described above.
[065] Figure 27 is a screen impression of a new sampling plan configuration screen for a user interface according to an illustrated modality, which can be presented on a display through a computer system processor, communicatively coupled to a portable monitoring instrument such as those described above.
[066] Figures 28A and 28B are screen prints of an upper and lower portion of a HACCP report screen of a user interface according to an illustrated modality, which can be presented on a display via a system processor. computer, communicatively coupled to a portable monitoring instrument such as those described above.
[067] Figure 28C is a screen print of the upper portion of the HACCP report screen of figure 28A with a graph selection element of a user interface according to an illustrated mode, which can be displayed on a display through a computer system processor, communicatively coupled to a portable monitoring instrument such as those described above.
[068] Figure 28D is a screen print of the upper portion of the HACCP report screen of figure 28A with a date range selection element from a user interface according to an illustrated modality, which can be presented in a display through a computer system processor, communicatively coupled to a portable monitoring instrument such as those described above.
[069] Figure 29 is a flow chart of a high-level method of operating a portable monitoring instrument to collect data collected, for example, using swabs, according to an illustrated modality.
[070] Figure 30 is a flow chart of a high-level method of operating a portable monitoring instrument to collect data collected, for example, through probes or external transducers, according to an illustrated modality.
[071] Figure 31 is a flow chart of a main method of operating a portable monitoring instrument to collect data collected, for example, using swabs, according to an illustrated modality.
[072] Figure 32 is a flowchart showing a first task subloop method of operating a portable monitoring instrument to collect data collected, for example, using swabs, according to an illustrated modality.
[073] Figure 33 is a block diagram showing a high voltage controller for controlling a high voltage supply for components of a portable monitoring instrument, according to an illustrated modality.
[074] Figure 34 is a block diagram showing a temperature controller to control a sensor temperature, for example, a multi-pixel photon counter of a portable monitoring instrument, according to an illustrated modality.
[075] Figure 35 is a flowchart showing an ATP measurement method for use in operation of a portable monitoring instrument to collect data from samples, for example, carried by swabs, according to an illustrated modality.
[076] Figure 36 is a flowchart showing a method of calibrating the dark count for use in operating a portable monitoring instrument to collect data from samples, for example, carried by swabs, according to an illustrated modality. DETAILED DESCRIPTION
[077] This order refers to apparatus and methods for monitoring process and environmental quality that can be used to provide critical information in a wide variety of scenarios. These scenarios include, but are not limited to, testing in the food, pharmaceutical, cosmetic and medical industries. These scenarios may also include environmental control and conditioning equipment for general use such as, but not limited to, commercial air conditioning equipment and cooling towers. Additional scenarios include sensitive environments potentially susceptible to malicious or inadvertent contamination with biological materials, such as military installations, hospitals or closed high-rise buildings.
[078] Drawings depicting certain modalities are provided for illustration purposes. In addition, the modalities are described in a context including the monitoring of pathogenic contamination by measuring light emission from a bioluminescent reaction. However, as a person skilled in the art will recognize, several aspects can also be applicable in a variety of other scenarios. Also, as will be recognized, equivalent modifications can be made without departing from the scope or spirit of the invention. Not all of these possible changes have been illustrated or described to avoid unnecessary detail that would obscure the description of the various modalities.
[079] Figures 1A and 1B, 2A and 2B, 3A and 3B and 4 represent four instruments for sample collection and analysis, each having different ergonomic housings. The ergonomic size, shape and profile of the housing allows a user to firmly hold the sample collection and analysis instrument with a single hand. Each of the sample collection and analysis instruments has a 102 user interface.
[080] Figures 1A and 1B show an example housing 104 with a tapered bottom portion 104a sized and sized to be easily held with a single hand and a relative larger top portion 104b that includes a portion of user interface 102 on the in the form of a touch-sensitive or touch-responsive display 102a. housing 104 can be a molded, extruded or stamped, single piece or multiple piece housing, having, for example, a front portion 106 and a rear portion 108 that are physically coupled using one or more reversible or non-reversible fasteners. One or more plastics, metals, or other similarly rigid, impact-resistant materials may be used for all or a portion of housing 104. A front surface 110 and rear surface 112 of housing 104 may have one or more textures applied to them for decorative purposes, or for functional purposes, for example to increase the surface roughness of the system to add slip resistance when the system is secured with a single hand. In some cases, the front surface 110 or the rear surface 112 of the housing 104 may have a microbiocidal additive or coating that inhibits biological growth in the system 104. In some cases, the front surface 110 and the rear surface 112 of the housing 104 may be of different materials or of the same material having different characteristics. For example, in one embodiment the rear portion 108 of housing 104 may be a plastic element having a rear surface 112 that is textured to improve the sliding resistance of the system when it is safe for a user. Conversely, the front portion 106 of the housing 104 can be a metal element having a front surface 110 that is smooth to enhance the appearance and cleanliness of the instrument 100.
[081] The terms "front", "rear", "upper", "lower" and other similar terms used here refer to positions in mutual relation and are not intended, nor should they be interpreted to indicate a specific spatial orientation or absolute direction . For example, a feature described as being on the “bottom” surface of a device can be on the “top” surface or a “side” surface of the device if the device is rotated or inverted; such rotation or inversion is envisaged to be within the scope of one or more of the claimed modalities described herein.
[082] Although only a touch sensitive or touch responsive display 102a is shown in figure 1A, user interface 102 can include any number of output devices such as lamps, indicators, screens, displays, meters, and the like. User interface 102 can also include any number of input devices such as buttons, knobs, switches, capacitive devices, wrist wheels, potentiometers, touch screens and the like. As shown in figure 1A, in some cases the user interface 102 may include at least one capacitive or resistive touch responsive or touch display 102a as both an input and an output (I / O) device. Such I / O devices advantageously reduce the number and size of penetrations through housing 104 thereby reducing the number of paths for liquid intrusion into housing 104. A flexible membrane 120 can be arranged nearby and used to seal all or a portion of the interface 102 from the external environment. At least in some cases, such as when a touch sensitive or touch responsive display 102a is used, a flexible, optically transparent, sealed 120p membrane can be arranged across all or a portion of the touch sensitive or touch display 102a. Although shown only in the front portion 106 of the housing 104, in some cases, the user interface 102 can extend up to the rear portion 108 of the housing 104. For example, a battery level indicator in the form of multiple illuminated elements can be located on the rear portion of housing 104.
[083] The housing 104 shown in figures 1A and 1B is generally a rectangular element having one or more rounded side edges. The housing 104 is thicker in the upper region 104b occupied by the touch sensitive or responsive display 102a and tapers both in width and thickness towards the lower region 104a of the housing 104 which is held in the hands of a user. The transition between the thickest portion 104b of housing 104 containing the torque sensitive or touch responsive display 102a and the thinner portion 104b of housing 104 is strongly tapered, providing a front profile reminiscent of a traditional inverted “milk bottle”. A material having a first set of properties including material, color and surface finish (for example, a fine-textured, white, injection-molded plastic) forms the front portion 106 at least partially surrounding the touch-sensitive or responsive display touch 102a to provide a high degree of contrast between the touch sensitive or touch display 102a and the front surface 110. A material having a second set of properties including material, color and surface finish (for example, a plastic medium-textured, gray, injection-molded) forms the entire rear portion 108. The “top” and “bottom” of the housing 104 are substantially 90 ° with respect to the front surface 110 and the rear surface 112 of the housing 104. At least in some cases, an articulated element (not visible in figure 1) can be attached to the upper portion 106 to provide a propstand for instrument 100.
[084] One or more doors, openings or holes can be arranged around housing 104, for example, at the bottom of housing 124. One or more communication doors 114 can be arranged in, on or around housing 104. Such communication ports 114 can be useful for communicatively coupling instrument 100 to an external device such as a personal computer or an external communications network. Communication port (s) 114 may, in some cases, have a proprietary interface or communication protocol configuration such that an adapter is required to connect communication port (s) 114 with a network or computer connection. Communication port 114 may, in other cases, have one or more interface configurations or communication protocols recognized in the industry, for example, Universal Serial bus (USB), IEEE 1394 (“FireWire®”), Thunderbolt®, RS- 232 or similar. Communication port (s) 114 may be partially or fully sealed or otherwise obstructed with a displaceable element, for example, an elastomeric cover or diaphragm, to reduce the likelihood of intrusion by liquid or dust on communication port (s) 114 is used to provide input data for instrument 100, for example, system configuration information, calibration information, operating system updates, time and date updates system, etc. At least in some cases, the communication port (s) 114 may also be useful to obtain output data from instrument 100, for example, analytical results and corresponding test dates, times and locations that are stored in an on-board memory in the instrument 100.
[085] One or more battery compartments 116 can be arranged in, on or around the instrument 100. For example, one or more battery compartments 116 can be arranged in the rear portion 108 of housing 104. The instrument 100 can use cells standard chemical battery, replaceable, for example, “AAA”, “AA” or “C” size batteries. in some cases, the system may use, instead, one or more secondary chemical battery cells (ie, rechargeable), for example, one or more nickel / cadmium energy cells, nickel metal hydride, or lithium ion. Where secondary or rechargeable chemical battery cells are used, the instrument 100 can be equipped with one or more power adapter ports and an internal or external power converter useful to replenish the charge in the secondary or rechargeable chemical battery cells. Alternatively or additionally, other types of energy sources or cells can be employed as energy sources on board, for example, fuel cells or super- or ultra-capacitor cells.
[086] One or more user-accessible probe insertion ports or ports, 118, sized and sized to accommodate a passage of a probe assembly or sample holder (not shown in figures 1A and 1B) are arranged in the housing 104, for example, on a top 122 of housing 104. The probe insertion port (s) or port (s) 118 may include a cover element (not clearly visible in figures 1A and 1B) which selectively covers substantially the probe insertion port (s) or inlet (s) 118 to prevent light from entering. The probe insertion port (s) or input 118 selectively provides access to a darkroom assembly located inside the instrument 100 and illustrated and discussed in detail below, for example, with reference to the figures 6-12.
[087] Figures 2A and 2B show another example of an instrument 200 having a housing 204. Housing 204 can be a molded, extruded or stamped housing, of one piece or multiple pieces, having, for example, a front portion 206 and a rear portion 208 that are physically coupled using one or more removable or non-removable fasteners that are inserted through the rear portion 208 and are consequently visible only in figure 2B. One or more rigid, similar plastics, metals, or other impact resistant materials may be used for all or a portion of housing 204. Front surface 210 and rear surface 212 of housing 204 may have one or more textures applied to them for decorative purposes, or for functional purposes, for example, to increase the surface roughness of the system 200 or to add texture to the instrument 200 in such a way that the instrument 200 can be secured or gripped firmly using only one hand. A coating or additive containing one or more biocides or similar materials useful to inhibit biological growth can be added to or incorporated into the front surface 210 or rear surface 212 of the housing 204. In some cases, the front surface 210 and the rear surface 212 of the housing 204 may be of different materials or of the same material having different characteristics, such as color or texture. For example, in one embodiment, the rear portion 208 of housing 204 may be a plastic element having a rear surface 212 that is textured to facilitate gripping the instrument 200. Conversely, front portion 206 of housing 204 may be a metal element having a front surface 210 that is smooth to enhance the appearance and cleanliness of the instrument 200.
[088] A flexible membrane 120 can be arranged nearby and used to seal all or a portion of a touch sensitive or touch responsive display 102a. Although shown only on the front portion 206 of the housing 204, in some cases, the user interface 102 can extend up to the rear portion 208 of the housing 204. For example, a battery level indicator in the form of multiple illuminated elements can be located on the rear portion of housing 204.
[089] The housing 204 shown in figures 2A and 2B is generally a rectangular element having one or more rounded side edges. The 204 housing is thicker in the safe region in the hands of a user, and tapers to a thinner cross section in the region occupied by the 102a touch-sensitive or torque-responsive display. The touch-sensitive or touch-responsive display 102a can optionally be arranged in a recess that extends longitudinally (i.e., from the top to the bottom) along the front portion 206 of housing 204, creating two substantially parallel ridges 226 in the front surface 210. A material having a first set of properties including material, color and surface finish (for example, a fine-textured, white, injection-molded plastic) forms the front portion 206 surrounding the touch-sensitive or responsive display. - touch touch 102a providing a high degree of contrast between the touch sensitive or touch responsive display 102a and the front surface 210. A material having a second set of properties including material, color and surface finish (for example, a plastic medium-textured, gray, injection-molded) forms the remaining front portion 206 and the entire rear portion 208. The top of housing 222 substantially It forms an angle of 90 ° with respect to both the front portion 206 and the rear portion 208. Conversely, the lower part of the housing 224 defines an arc extending from the front portion 206 to the rear portion 208.
[090] Figures 3A and 3B show another example of an instrument 300 having a housing 304 at least partially surrounding a touch sensitive or touch responsive display 102a. Housing 304 may be a molded, extruded or stamped, single-piece or multi-piece housing, having, for example, a front portion 306 and a rear portion 308 that are physically coupled using one or more reversible or non-reversible fasteners. One or more rigid, similar impact-resistant plastics, metals, or other materials may be used for all or a portion of housing 304. Front surface 310 and rear surface 312 of housing 304 may have one or more textures applied to them for decorative purposes, or for functional purposes, for example, to increase the surface roughness of the instrument 300 and to add texture in such a way that the instrument 300 can be held or gripped firmly using only one hand. A coating or additive containing one or more biocides or similar materials useful to inhibit biological growth can be added to or incorporated into the front surface 310 or rear surface 312 of the housing 304. In some cases, the front surface 310 and the rear surface 312 of the housing 304 may be of different materials or of the same material having different characteristics, such as color or texture. For example, in one embodiment, the rear portion 308 of housing 304 may be a plastic element having a rear surface 312 that is textured to facilitate gripping the instrument 300 when held by a user. Conversely, the front portion 306 of housing 304 may be a metal element having a front surface 310 that is smooth to enhance the appearance and cleanliness of the instrument 300.
[091] A flexible membrane 120 can be arranged nearby and used to seal all or a portion of a touch sensitive or touch responsive display 102a. Although shown only in the front portion 306 of housing 304, in some cases, a portion of user interface 102 may extend to rear portion 308 of housing 304. For example, a battery level indicator in the form of multiple illuminated elements may be located at the rear of housing 304.
[092] The housing 304 shown in figures 3A and 3B is generally a rectangular element having one or more rounded side edges. Housing 304 is thicker in the region occupied by the touch-sensitive or touch-responsive display 102a, and tapers in width towards the region of housing 304 to grab a user's hand. The transition between the thickest portion of the housing 300 containing the touch sensitive or responsive display 102a and the narrower portion of the housing 304 is sharply tapered, again providing a front profile reminiscent of a traditional "milk bottle". A material having a first set of properties including material, color and surface finish (for example, a fine-textured, white, injection-molded plastic) forms the front portion 306 providing a high degree of contrast between the touch-sensitive display or touch responsive 102a and the front surface 210. A material having a second set of properties including material, color and surface finish (e.g., a medium-textured, gray, injection-molded plastic) forms the rear portion 308. The top of the housing 322 substantially forms a 90 ° angle with respect to both the front portion 306 and the rear portion 308. Conversely, the lower portion of the housing 324 defines an arc extending from the front portion 306 to the rear portion 308.
[093] Figure 4 shows yet another example instrument 400 having a housing 404 that at least partially surrounds a touch sensitive or touch responsive display 102a. housing 404 can be a molded, extruded or stamped single or multiple-piece housing, having a front portion 406 and a rear portion 408 that are physically coupled together using one or more fasteners. One or more plastics, metals or other impact resistant, rigid, similar materials can be used for all or a portion of the housing 404. The front surface 410 and the rear surface 412 of the housing 404 can have one or more textures applied to them for decorative or functional purposes, for example, to increase the surface roughness of the system 400 to facilitate grasping the instrument 400 using only one hand. A coating or additive containing one or more biocides or similar materials useful to inhibit biological growth can be added to or incorporated into the front surface 410 or rear surface 412 of housing 404. In some cases, the front surface 410 and the rear surface 412 of the housing 404 may be of different materials or of the same material having different characteristics such as color or texture. For example, the rear portion 408 of the housing 404 may be a plastic element having a rear surface 412 that is textured to improve the sliding resistance of the system when held by a user. Conversely, the front portion 406 of the housing 404 may be a metal element having a front surface 410 that is smooth to improve the appearance and cleanliness of the instrument 400.
[094] A flexible membrane 120 can be arranged nearby and used to seal all or a portion of the touch sensitive or touch responsive display 102a. although shown only in the front portion 406 of the housing 404, in some cases, a portion of the user interface 102 may extend to the rear portion 408 of the housing 404. For example, a battery level indicator in the form of multiple illuminated elements may be located at the rear of housing 404.
[095] The housing 404 shown in figure 4 is generally a rectangular element having one or more rounded side edges. The housing 404 is generally uniform in thickness and tapers in width towards the region of housing 404 to be held in the hand of a user. The transition between the thickest portion of housing 400 containing the user interface and the narrowest portion of housing 404 is sharply tapered, again providing a front profile reminiscent of a traditional "milk bottle". A material having a first set of properties including material, color and surface finish (for example, a fine-textured, white, injection-molded plastic) forms the front portion 406 providing a high degree of contrast between the touch-sensitive display or responsive to touch 102a and the front surface 410. A material having a second set of properties including material, color and surface finish (for example, a medium textured plastic, gray color, injection molded) in addition to the rear portion 408 The top of housing 422 substantially forms an angle of 90 ° with respect to both the front portion 406 and the rear portion 408. The bottom of housing 424 is chamfered front and rear and forms substantially an angle of 90 ° with respect to both the portion front 406 as well as the rear 408.
[096] Figure 5 shows a touch sensitive or touch responsive display 102a communicatively coupled to a logic panel 502. Although represented as a single printed circuit board in figure 5, logic panel 502 can include components spread across any number of separate logic panels connected together. For example, logic panel 502 can include various components (for example, electrical or electronic components, connectors) and associated pathways or conductive traces. Logic panel 502 can be partially or fully arranged in housing 104, 204, 304, 404. The sample collection and analysis system can include at least one processor 504, non-transitory storage media 506, one or more power converters 508, an input / output controller 510, a graphics processing unit 512 and a network interface 516. A photon detector assembly (not shown in figure 5) is positioned in relation to a darkroom of a photon assembly. darkroom (not shown in figure 5), for example, partially arranged in it is used to measure, detect or otherwise feel bioluminescence of samples. The photon detector assembly is communicatively coupled to the logic panel 502 and can, in some cases, also be physically coupled to the logic panel 502.
[097] One or more 504 processors may include one or more devices capable of executing machine executable instructions providing sample testing and analysis functionality for the sample collection and testing instrument 100, 200, 300, 400. In some cases, one or more 504 processors may include multifunction devices capable of providing input / output, logic, communications, and graphic output, for example, a System device on a chip (SoC) or application specific Integrated Circuit (ASIC). In other cases, one or more processors 504 may include a plurality of discrete devices, each capable of providing one or more functions such as I / O, logic, communications and the like. One or more processors may include one or more single-core or multi-core microprocessors, for example, an AMD® K8, K10, Bulldozer, or Bobcat series processors; a Snapdragon Qualcomm® series processor, a Tegra® NVIDIA® series processor, or Intel®, x86, Pentium® or Atom® series processors. One or more processors 504 may also include one or more programmable port arrangements (PGA); one or more digital signal processors (DSP); one or more reduced instruction set (RISC) computers; one or more programmable logic circuits (PLCs), and the like. The use of one or more low-power or mobile 504 processors can advantageously increase the system's battery life. One or more 504 processors may include a limited amount of non-transitory storage in the form of basic input / output system memory (BIOS), cache, or other read-only memory containing components such as an operating system and machine executable instructions that when performed by one or more 504 processors provides sample collection and test functionality for the system.
[098] One or more 504 processors may include, or be communicatively coupled to one or more oscillators and one or more real-time (RTC) clocks useful in tracking, organizing and timing events such as calibration activities, service activities or maintenance, data collection activities, data recording activities, data transfer activities, communications activities and the like. One or more processors 504 can be communicatively coupled to non-transitory storage media 506, one or more power converters 508, one or more communication ports 510, and photon detection assembly using one or more serial data buses or parallel.
[099] The 506 non-transitory storage media may include one or more computer-readable devices or volatile and / or non-volatile processors (for example, memory, rotation media, solid state media) capable of storing data. Such devices may include random access memory (RAM) 506a and read-only memory (ROM) 506b in the sample collection and test instrument 100, 200, 300, 400. Such devices may also include one or more removable storage devices 506c as one or more secure digital interfaces (“SD”) capable of accommodating the insertion of an SD compliant memory device. In some cases, all or a portion of the data contained in the non-transitory memory in the sample collection and test instrument 100,200, 300, 400 can be transferred to a removable storage device communicatively coupled to the system.
[0100] The 506 non-transitory storage media may include one or more types of magnetic, electroresist, molecular, or optical storage media including, but not limited to, one or more hard disk drives (“HDD”), storage media electrostatic such as solid state drives (“SSD”), electrically erasable programmable read-only memory (“EEPROM”) and similar current and future storage devices. In addition to storing executable instructions on the machine and operating system, the 506 non-transitory storage media can also be useful for storing analytical results, test sequences, test points, time and date data, and similar data related to them. Such data retention can form at least a portion of a critical risk analysis control point (HACCP) program, for example, in a pharmaceutical or food production or preparation facility. The 506 non-transitory storage media can have any storage capacity or physical configuration. In one case, the total storage capacity can be 1 gigabyte (1 GB) spread across four storage devices mounted on a 256 megabyte (256 MB) addressable parallel board. Other devices such as single in-line memory modules (SIMM), dual in-line memory module packages (DIMM), and other packages and capabilities can also be used to provide a degree of system customization capability. The total storage capacity of the 100, 200, 300, 400 sample collection and test instrument can vary from approximately 128 MB to approximately 512 GB; from approximately 128 MB to approximately 512 GB; from approximately 128 MB to approximately 256 GB; from approximately 128 MB to approximately 128 GB; or from approximately 128 MB to approximately 10 GB.
[0101] One or more 508 power converters may include any number of systems or devices suitable for changing or adjusting the voltage, current or waveform of an energy supplied to the sample collection and test instrument 100, 200, 300, 400 for a different voltage, current or waveform useful in triggering the sample collection and test system. For example, one or more 508 power converters can convert 60 Hz, 120V alternating current into 3V direct current used by the 504 processor and photodetector. In some cases, all or a portion of one or more energy converters 508 is arranged in housing 104, 204, 304, 404, while in other cases all or a portion may be arranged external to the housing, for example, in the form of a plug-mounted converter / transformer (for example, a “wall bulge” type power source). At least in some cases, all or a portion of the energy provided by one or more 508 energy converters is used to increase the load on the energy storage cells (for example, rechargeable batteries or the like) in the sample collection and test instrument 100, 200, 300, 400. One or more 508 power converters can provide one or more output waveforms, for example, direct current, square wave, sawtooth wave, or any other useful form of power source . One or more 508 power converters can provide one or more output voltages, for example, 1.5V, 3.0V, 5.0V, 9.0V or 12V.
[0102] One or more 508 power converters may also include one or more protection devices, for example, one or more replaceable or non-replaceable fuses or similar overcurrent protection devices. One or more 508 power converters may include one or more filtration or regulation devices or systems to reduce the possibility of over / under voltage conditions in the 100, 200, 300, 400 sample collection and test instrument.
[0103] Analog and digital data are imported into and exported from the sample collection and analysis system using an I / O controller 510 communicatively coupled to at least one processor 504 and non-transitory storage media 506 through bus 524. In addition to receiving input from a touch sensitive or touch responsive display 102a, one or more additional input devices can be communicatively coupled to the I / O 510 controller. At least in some cases, the I / O 510 controller can be communicatively coupled to one or more serial interfaces recognized in the industry, for example, a universal serial bus (USB), mini-USB, micro-USB, IEEE 1394, Intel® Thunderbolt®, or any similar current or future serial interface. At least in some cases, the I / O controller can be communicatively coupled to one or more wireless interfaces, for example, a Bluetooth® wireless interface, a wireless near-field communication (NFC) interface, a wireless interface ZigBee®, or any similar current or future wireless interface. At least in some cases, the I / O controller can be communicatively coupled to one or more parallel interfaces. At least in some cases, the I / O controller can be communi- catedly coupled to one or more proprietary interfaces having a proprietary pin or connector configuration.
[0104] At least in some cases, the I / O controller 510 may include one or more analytical device ports to connect one or more external analytical sensors 526 to the sample collection and analysis instrument 100, 200, 300, 400. Devices External analytics attachable to the sample collection and analysis system include, but are not limited to temperature probes, pH probes, dissolved oxygen probes, conductivity probes and the like. Additional analytical measurements can be collected based, for example, on the installation's HACCP plan. Collecting multiple signals from multiple devices using a single system advantageously provides the ability to generate complete HACCP documentation, including biological contamination data and other physical data correlated to each critical control point identified and stored as a logical group on the media 506 non-transitory storage data. Such data may be periodically exported to one or more external devices to provide HACCP documentation. When an external probe is communicatively coupled to the system, the touch sensitive or touch responsive display 102a can display data relevant to the measurements provided by the external probe. For example, an external pH probe can cause the touch sensitive or touch responsive display 102a to display the pH felt using the pH probe and the level of biological contamination detected using the internal photon.
[0105] The I / O controller 510 can also be used to support additional input or output devices that are physically or logically separated from the 102 user interface. At least in some cases, one or more buttons, switches, knobs, diais, or similar tactile input devices can be communicatively coupled to the I / O 510 controller instead of, or in addition to, the touch sensitive or touch responsive display 102a. Such devices can include a full or partial keyboard (0-9, #, *), function buttons, or a full or partial keyboard (QWERTY, etc.) can be arranged in the system.
[0106] At least in some cases, the I / O 510 controller can facilitate the exchange of data between the sample collection and analysis instrument 100, 200, 300, 400 and one or more external devices. For example, the I / O controller 510 can be used to synchronize or otherwise connect the 100, 200, 300, 400 sample collection and analysis instrument to an external device using a USB or proprietary interface for the purpose of exporting data analytics recorded in the 506 non-transitory storage medium. Such data export capabilities can advantageously assist in maintaining a cohesive HACCP database on an external device or an external network that provides regulatory or management agency access to analytical data. In other cases, the I / O controller 510 can be used to synchronize or otherwise connect the sample collection and analysis instrument 100, 200, 300, 400 to an external device using a USB interface for the purpose of obtaining software updates , firmware updates, operating system updates, data security updates, and the like. At least in some cases, all or a portion of software, firmware or operating system updates can be downloaded over one or more networks, such as the Internet or the World Wide Web, through one or more portals or application stores.
[0107] The graphics processing unit 512 is shown communicatively coupled to the touch sensitive or touch responsive display 102a through one or more ribbon cables 514 or similar. In some cases, a graphics processing unit 512 can be partially or fully integrated at least in a 504 processor. Although only a touch sensitive or touch responsive display 102a is shown attached to the sample collection and analysis instrument 100, 200, 300, 400, any number of touch sensitive or touch responsive displays 102 or other user interface elements or devices can be used to provide multiple outputs to, or collect multiple inputs from, the user. At least in some cases, the touch sensitive or touch responsive display 102a can show 100, 200, 300, 400 sample collection and analysis instrument output and collect input using a graphical user interface (GUI) that displays and collects via least a portion of the data in the form of user-selectable images or icons.
[0108] The touch sensitive or touch responsive display 102a can include any current or future color or monochrome device having an appropriate physical form factor (for example, thin) and capable of displaying data as a liquid crystal display (LCD) , a light emitting diode (LED) display, a gas plasma display, an organic LED display, an eInk® display and the like. One or more other lights, indicators, transparent or colored incandescent lamps, transparent or colored LEDs, or the like, can also be used to indicate power status, charge status, battery level status, communication status, data links, peripheral and similar device status. One or more different types of user input devices can be used, for example, the user can mainly interact with one or more 504 processors via a touch sensitive or touch responsive display 102a, while communicating status and battery level are communicated using one or more LEDs. In some cases, user interface 102 may include a touch-sensitive or touch-sensitive display 102a from which at least one processor 504 receives input via I / O controller 510.
[0109] The network interface 516 can also be communicatively coupled to the sample collection and analysis instrument 100, 200, 300, 400. The network interface can include one or more transceivers or wireless network interfaces 516a (for example, IEEE 802.11 “WiFi” or similar), one or more transceivers or wired network interfaces 516b (for example, Ethernet or similar) or combinations thereof. At least in some modalities, the sample collection and analysis instrument 100, 200, 300, 400 can synchronize or exchange encrypted or unencrypted data with one or more external devices via the 516 network interface, for example, over a connection secure wireless network between the sample collection and analysis instrument 100, 200, 300, 400 and the external device. In some cases, the network interface 516 may include an illuminator (not shown), for example, a laser or a light emitting diode (LED) such as an infrared LED for optically transmitting information. The transmission of optical data requires a line of sight between the transmitter and the receiver, which can be considered a disadvantage, however it can be considered advantageous where security is a concern or where location determination is desirable.
[0110] The sample collection and analysis instrument 100, 200, 300, 400 can optionally include a 522 global positioning system (GPS) receiver to receive GPS positioning information from one or more GPS satellites. Such GPS data can be advantageously associated with analytical results stored in the 506 non-transitory storage medium and can be used to verify the location, time and date when a specific sample was obtained or a specific analysis performed. As part of an integrated HACCP program, such positional GPS data can advantageously provide additional evidence that samples collected under the auspices of an HACCP program are taken at the right times and in the right places.
[0111] The 100, 200, 300, 400 sample collection and test instrument can be equipped with one or more lighting systems, for example, a rear lighting system, to illuminate the user interface 102 and allow system operation under low ambient light conditions. To allow sample collection in low ambient light conditions, the 100, 200, 300, 400 sample collection and test instrument can be equipped with an outdoor lighting system, for example, an LED flashlight or similar.
[0112] Figure 6 shows an example sample collection and test instrument, 600, with the front portion of housing 106, 206, 306, 406 removed to expose at least a portion of the logic panel 502 and the camera assembly dark 602.
[0113] The darkroom assembly 602 includes a sample insertion tube 604 that defines or forms a passageway, a darkroom 606 having at least one partially concave inner surface 608 at a distal end of the sample insertion tube 604 and passage , a photon detection assembly 610, and optionally a heat dissipation assembly 612. A sample holder as a probe assembly (not shown in figure 6) containing a biological sample and one or more reagents is inserted into the assembly passage darkroom 600. The combination of the instrument 100, 200, 300 and 400 and the sample holder or probe assembly comprises a sample collection and test system. The sample holder or probe mount typically receives swabs, used to sample surfaces and other objects or materials.
[0114] After insertion, a distal portion of the probe assembly that contains a sample or specimen is positioned in the darkroom 606. Bioluminescence from the sample is reflected and / or focused by the inner surface of the darkroom towards the detection detector assembly photon 610, which detects, measures or otherwise senses one or more characteristics of bioluminescence, for example, a total level or quantity or intensity of light. The photon detection assembly 610 can advantageously employ a multi-pixel photon counter (MPPC, for example, set of avalanche photodiodes). The photon detection assembly 610 is cooled by the heat dissipation assembly 612 which transports heat away from the photon detection assembly 610 and dissipates heat.
[0115] The sample insertion tube 604 is defined by a generally cylindrical structure having a probe insertion port or port 118 arranged near the top 122, 222, 322, 422 of the sample collection and test instrument 100, 200, 300, 400, respectively. The darkroom 606 is located at the distal end of the sample insertion tube 604, opposite the probe insertion port or port 118. The sample collection tube 604 includes a probe insertion port or port 118 located at a first end close to an outer surface of the housing to accommodate the insertion of a sample holder or probe assembly in it. The sample holder or probe assembly is inserted through the probe insertion port or port 118 into the passageway. A distal portion of the sample holder or probe mount, which is optically transparent at least for some wavelengths of interest and which contains at least a little of the sample for bioluminescent analysis, is positioned in the darkroom 606, in a field of the photon detector (for example, MPPC) of the 610 photon detection assembly.
[0116] The darkroom assembly 602 can be formed from parts of thermoplastic, injection molded, cast, formed or extruded. In some cases, all or a portion of the darkroom assembly 602 may include a molten or formed metal structure. Several rings, guides and supports (not visible in figure 6) can be positioned internally, for example, in the passage of the darkroom assembly 602, to precisely, safely and reproducibly position the sample holder or probe assembly on it. Some or all of the rings, guides or supports may limit the type, number or physical configuration of the sample holders or probe assemblies that can be received in the passage of the 602 darkroom assembly, for example, some or all of the rings, guides or holders in the darkroom assembly 602 may have profiles specifically adapted to allow passage of specific sample holders or probe assemblies having an appropriate size, dimension or reagent content, while blocking the entry or passage of other non-sample holders or probe assemblies.
[0117] The passage of the sample insertion tube 604 ends in the darkroom 606. The darkroom provides a volume that is protected from external sources of light, and that has a reflective inner surface to reflect bioluminescence, increasing the number of detectable photons by a photon detector from the 610 photon detection assembly.
[0118] A photon detection assembly 610 is arranged nearby and can, in some cases, form at least a portion of one of the walls or other surfaces that form or define darkroom 606. In darkroom 606, photons emitted from of a bioluminescent sample in the probe assembly can be reflected to increase measurement or detection accuracy. The level of biological contamination present in the sample is directly or indirectly indicated by the quantity or number of photons detected by the photon detector of the 610 photon detection assembly. The photons that reach the photon detector must therefore be attributable only to the bioluminescent sample. . Scattered photons not attributable to the bioluminescent sample, for example, photons attributable to ambient or external lighting or heat, will adversely affect the performance of the 610 photon detector assembly. Such scattered photons can be reduced or even prevented from entering the darkroom 606 for providing a 606 light-proof darkroom and for using the sample holder or probe assembly and / or cover to optically seal the 606 darkroom.
[0119] Although the darkroom 606 can have any shape or form, certain shapes that increase the reflection towards the 610 photon detector are strongly preferred. Preferably, an interior of the darkroom 606 will have a physical shape capable of reflecting or otherwise directing at least a portion of the photons generated by the bioluminescent sample towards the 610 photon detector assembly. Such a reflection can be performed using one or more surfaces internal concave 608 integrally formed or added to an interior space of the darkroom 606. At least in some cases, the concave inner surface (s) 608 may be generically cylindrical, for example, as shown in figure 6. It is particularly advantageous where the inner surface (s) 608 in the darkroom 606 are substantially spherical or hemispherical, unlike where there are openings in the darkroom 606. In some cases, the (s) reflective inner surface (s) 608 can (m) reflect only a portion of the electromagnetic spectrum, for example, electromagnetic radiation between 500 nanometers (nm) and 600 nm.
[0120] The darkroom 606 can be formed as two separate pieces of molded plastic. As best illustrated in figure 13B, in some implementations, a coating, layer or reflective material 1312 can be arranged at least on a portion of a surface 1314 of the molded plastic parts 1316 that will form the darkroom 606. For example, a coating, reflective metallic layer or material 1312 can be applied to the inner or inner concave surfaces 1314 of the parts 1316 that will form the darkroom 606. The reflective metallic layer, layer or material 1312 may include some form of the silver chemical element (Ag), or may include some other optically reflective metallic element. The coating, layer or reflective metallic material 1312 can be deposited on the inner surface 1314, for example, by means of a thermal or steam arrangement. Alternatively, the reflective coating, layer or material 1312 can be applied in some other way. For example, a coating, layer or reflective material 1312 can be applied to the concave surfaces 1314 of molded plastic parts 1316 through electroplating as electroplating. Less preferably, a coating, layer or reflective material 1312 can be applied to the concave surfaces 1314 of the molded plastic parts 1316 as a sheet. The coating, layer or reflective metallic material 1312 can be polished after application, or can be applied in a way that produces a high degree of reflection without the need for polishing. A protective layer, coating or material can be formed deposited on or overlapping the reflective coating, layer or material 1312. For example, a 1318 protective oxide dielectric coating can be formed, for example, using techniques commonly used to form layers of passivation in silicon manufacturing processes. Oxide 1318 can provide environmental protection to the underlying reflective coating, layer or material 1312. Oxide 1318 can additionally or alternatively serve as a filter, ensuring reflection of certain defined wavelengths or wavelength ranges, while reducing or eliminating the reflection of other wavelengths or wavelength bands. In this way, wavelengths that are not of interest can be advantageously suppressed. The type of oxide, and the thickness of oxide 1318, can be controlled to obtain the desired filtration.
[0121] Less preferable from a metallic layer, a highly reflective white coating can be employed, for example, through a coating comprising a form of titanium dioxide. Also less preferable to a metallic layer, a layer of barium compound can be employed, however, this can be difficult to safely adhere to the concave surfaces of the molded plastic parts.
[0122] Photon detection assembly 610 is physically and operatively coupled to the interior of darkroom 606 in such a way that a photon detector is positioned to detect photons in or emanating from darkroom 606. A spherical reflective inner surface 608 darkroom 606 advantageously reflects photons, and focuses the photons on the photon detector. As explained in detail below, certain aspects of the sample holder or probe assembly, particularly in combination with the geometry of a spherical reflective inner surface 608 and the general positioning and orientation of the photon detection assembly with respect to the 606 darkroom, focuses synergistically photons for highly accurate results or detection.
[0123] In some cases, the photon detection assembly 610 can form at least a portion of the inner surface 608 of the darkroom 606. In operation, photons emitted by the bioluminescent sample reach or fall on one or more photon detectors (for example, example, MPPC) of the 610 photon detection assembly. The photons that fall on the photon detector (s) create an electrical signal that can be filtered, amplified and transmitted to one or more 504 processors. The characteristic (for example, voltage, current, charge cycle) of the electrical signal provided by the 610 photon detection assembly is related to the number of photons emitted by the bioluminescent sample. The number of photons emitted by the bioluminescent sample is, in turn, proportional to the amount of biological material present in the sample. The electrical signal generated by the 610 photon detection assembly therefore provides an indication not only of the presence but also of the relative amount of biological material present in the bioluminescent sample. At least in some cases, the 610 photon detection assembly may be particularly sensitive to heat that adversely compromises and affects the accuracy, reliability and reproducibility of the electrical signals provided by the 610 photon detection assembly. At least in some cases, an assembly heat dissipation device 612 can be thermally conductively coupled to the photon detection assembly 610 to remove heat away from it, and dissipate at least a portion of such heat, for example, through fins 612a or some other dissipation structure of heat.
[0124] The 612 heat dissipation assembly may include one or more active or passive structures, devices or systems that are thermally conductively coupled to the 610 photon detection assembly. In some cases, the 612 heat dissipation assembly may include a single-piece or multi-piece extended surface heat transfer device, active or passive (for example, an extended surface fin heat transfer device) that is thermally coupled to the 610 photon detection assembly as shown in figure 6. In some cases, the heat dissipation assembly 612 may include one or more heat tubes or similar structures using a phase change heat transfer fluid to conduct heat away from photon detection generically 610 for dissipation elsewhere in housing 104, 204, 304 and 404 or from housing 104, 204, 304, 404 to the environment. In other cases, the heat sink assembly 612 may include an active cooler, for example, a fan passing air through a thermally conductively extended surface heat sink coupled to the 610 photon detection assembly, or a thermally conductive Peltier cooler - coupled to the 610 photon detection assembly.
[0125] Figure 7 shows a portion of an example 700 sample collection and test instrument, according to an illustrated embodiment. In particular, figure 7 shows the darkroom assembly 602 including a sample insertion tube 604, and a photon detection assembly 610 which are both physically and communicatively coupled to the logic panel 502, as shown in figure 7, in some cases the darkroom 702 may be a multi-piece assembly that is physically coupled to the photon detection assembly 704 using one or more fasteners 706, for example, one or more threaded fasteners like the threads shown in figure 7. In others cases the darkroom 702 can be attached to the photon detection assembly 704 through thermal bonding or through one or more chemical adhesives. One or more sealing elements or gaskets can be arranged between the darkroom 702 and the photon detection assembly 704 to provide a light tight seal that reduces the number of scattered photons entering the darkroom 702.
[0126] At least in some cases, the darkroom assembly 602 can be physically coupled to logic panel 502, for example, using structural supports 708 as uprights and one or more fasteners 706, for example, one or more threaded fasteners as the screws shown in figure 7. In other cases, the darkroom 602 can be physically attached to the logic panel 502 using non-reversible connectors, for example, a plurality of structural supports 708 that are thermally or adhesively connected to the logic panel 502 or riveted on it, thereby rigidly attaching the darkroom 602 to the logic panel 502.
[0127] Figure 8A shows an example 850 test swab in use in collecting samples or specimens, according to an illustrated modality.
[0128] The test swab 850 includes at least one shaft element 852 having a swab tip 854 made of absorbent or liquid-permeable material such as cotton, Dacron, poly-foam or porous liquid-permeable plastic sampling surfaces , arranged at one end. The tip of the 854 swab can be pre-moistened to assist in sample collection. In some cases, the tip of the swab 854 can be selected, sized, molded or configured to retain a known volume of liquid sample, for example, 0.1 milliliters (ml); 0.5 ml; 1.0 ml; 2.0 ml; 3.0 ml; or 5.0 ml. The liquid-permeable material allows a reagent solution used with probe assembly 800 (figure 8B) to flow through or along shaft element 852 to the tip of swab 854 and react with any biological matter present in it. The reagent solution can leach biological matter from the 854 swab tip.
[0129] The test swab 850 can be used to recover a sample or specimen from a surface or object of 856 interest. For example, a user can swipe or otherwise contact a surface or object of interest 856 with a portion (for example, swab tip 854) of test swab 850. The surface or object of interest 856 can take any of a wide variety of shapes. For example, the surface or object of interest 856 may be a surface on which food manufacturing or preparation takes place or with which food is prepared or manufactured. The surface of interest 856 can be part of an object used during manufacture or food preparation, for example, a bowl, roasting leaves, pan, cauldron, bowl, spoon, ladle, spatula or mixer paddles. The surface of interest 856 can be a piece of equipment or part of a piece of equipment used for preparation or manufacture, or for approximately any activity in which hygiene is important.
[0130] After collecting the sample or specimen, the test swab 850 is placed in the sample holder or probe assembly 800 (figure 8B), which in turn is inserted in the passage of the darkroom assembly 602 of the instrument 100, 200 , 300, 400.
[0131] Figure 8B shows a test stand or probe assembly 800, for example, which contains a sample test swab 850 (figure 8B), according to an illustrated embodiment. Figure 8D shows a portion of the sample holder or probe assembly 800 containing a test swab 850 and with a plunger 860 of the sample holder or probe assembly 800 in a disengaged position or condition, before violating any reservoirs or chambers, according to an illustrated modality. Figure 8E shows the portion of the sample holder or probe assembly 800 containing the test swab 850 and with the plunger 860 in a engaged condition or position, violating reservoirs or chambers to release their contents, according to an illustrated modality .
[0132] The test stand or probe assembly 800 combines synergistically and cooperates with the instrument structure 100, 200, 300, 400 to form a sample collection and test system with high sensitivity and precision.
[0133] Probe assembly 800 is an elongated hollow element having an optically transparent chamber 802 (figure 8B) disposed at a distal end 803 of probe assembly 800 and one or more reagent chambers 804a, 804b (collectively 804) arranged between the distal end 803 and a close end 805 of the probe assembly 800 which is spaced across a length of the probe assembly 800 from the distal end 803. A first hollow cylindrical element 806 and a second hollow cylindrical element 808 are arranged between the optically transparent chamber 802 and reagent chamber (s) 804. A conduit or passageway 810 extends through at least the first cylindrical element 806, second cylindrical element 808 and terminates in the optically transparent chamber 802. The conduit or passageway 810 couples the optically transparent chamber 802 fluidly to the reagent chamber (s) 804.
[0134] As best illustrated in figures 8D and E, a first reagent chamber 804a can be a "wet" chamber storing a liquid solution, and a second reagent chamber 804b can be a "dry" chamber stored a powder or material in particles or solid. The solution and / or the solid can be a reagent. Typically, the solid can be the reagent, and the liquid solution is used to dissolve the solid reagent in contact with it. Each of the reagent chambers 804a, 804b can be sealed by a respective frangible membrane 862a, 862b (illustrated in figure 8D, collectively 862), respectively. Plunger 860 can be advanced downwards from the position shown in figure 8D to reach the position shown in figure 8E. When advancing to the position illustrated in figure 8E, a penetration structure 864 violates (for example, penetrates, breaks) the frangible membranes 862, releasing the contents of the reagent chambers 804.
[0135] The liquid and solid can mix, activating the reagent. The resulting solution can enter a channel 866 on the axis element 852 of the test swab 850 to the tip of the swab 854 (figure 8A). the shaft element 852 can be retained by a swab retaining portion 868 which can include a port 870 to provide fluid communication into the channel. The knuckle retaining portion 868 may include bias elements (e.g., laminated springs) 872 to elastically engage the shaft element 852 when received in an opening 873 of the swab retaining portion 868.
[0136] The plunger 860 can be selectively removably attached to a main body portion 874 via a collar 876 or other coupler. The collar 876 may include a thread that threadably engages a complementary thread loaded into the main body portion 874. One or more seals may be formed between the plunger 860 and the main body portion 874 to prevent leakage of solution and / or ingress of light. Seals can include various O-ring seals (e.g., rubber, latex, polymer) or can be obtained by a tight interference fit between the plunger portions 860 and an internal surface of the main body portion 874.
[0137] The main body portion 874 can be coupled to a portion of tube 878. In particular, the main body portion 874 may have a necked or reduced diameter portion 880 that attaches to the portion of pipe 878. The portion of tube 878 can be attached to the narrow or small diameter portion 880 through an interference fit, threads or some other physical coupler.
[0138] At least in some cases, a portion of the shaft element 852 (e.g., portion spaced away from the swab tip 854) may contain a similar edge, tip, or penetration structure useful in penetrating or breaking through a metal, sheet , plastic, glass or similar membrane that seals the 804 reagent chamber.
[0139] Test swab 850, including shaft element 852 and swab tip 854, can be sized to fully fit into conduit 810 by extending through the first cylindrical element 806 and the second cylindrical element 808. In some implementations, the swab test 850 is received such that the swab tip 854 resides at least partially in the optically transparent chamber 802. In other implementations, the swab 850 is received such that the swab tip 854 does not reside in the optically transparent chamber 802. Such implementations are based on reagent solution leaching sufficient quantities or material from the swab tip 854 and into the optically transparent chamber 802.
[0140] The optically transparent chamber 802 is a hollow chamber that is formed of a material having optically transparent properties at least with respect to wavelengths of bioluminescence emitted from the sample and / or reagent. For example, the optically transparent chamber 802 may be transparent (i.e., substantially pass) electromagnetic radiation having wavelengths from approximately 370 nm to approximately 750 nm; from approximately 450 nm to approximately 650 nm; or from approximately 500 nm to approximately 600 nm. The optically transparent chamber 802 may, in some cases, be a thermoplastic material such as transparent polycarbonate or the like. For example, the sample holder or probe assembly 800 can be formed through a two-charge injection molding process, one charge being, for example, a transparent polycarbonate and the other charge being, for example, a plastic of opaque acrylonitrile styrene butadiene (ABS). In other cases, the optically transparent chamber 802 may be a glass, for example, borosilicate glass or the like. The interior of at least the optically transparent chamber 802 is preferably sterile, containing no biological material that would adversely impact the accuracy of test results.
[0141] After mixing with one or more reagents (for example, luciferase), one or more biological compounds, including, but not limited to, adenosine triphosphate (ATP) will bioluminescence and emit photons. The photons emitted by the biolumescence will fall on the photon detector of the 610 photon detector assembly or will be reflected inside the darkroom 606 and eventually reach the photon detector of the 610 photon detector assembly. hit the photon detector of photon detection assembly 610 provide an indication of the presence and relative amount of biological matter present in the swab tip 854, without significant loss in the darkroom and without significant interference from scattered photons or thermal noise.
[0142] Reagent chamber (s) 804 contains one or more reagents that when mixed with the sample on the swab tip 854, reacts and causes at least a portion of the biological material present in the swab test perform bioluminescence. In some cases, the reagent chamber 804 may contain more than one reagent, or different reagents may be contained in a separate reagent chamber (s). for example, reagent chamber 804 may contain a solid reagent and a liquid reagent that combine when a sheath containing reagents in reagent chamber 804 is ruptured by the pointed end of shaft element 852. In some cases, bioluminescence can be caused by the reaction of adenosine triphosphate with one or more enzymes such as luciferase, according to the following reaction: ATP + D-Luciferin + 02 -> Oxyluciferin + AMP + PPi + CO2 + light (560 nm)
[0143] Reagents in the 804 reagent chamber flow through or around the test swab and into the swab tip 854. The swab tip 854 can be positioned in the optically transparent chamber 802 with the reagent solution. Alternatively, the reagent solution with sample or leached specimen collected in the optically transparent 802 chamber. At least in some implementations, the reagents can be sealed or retained in the 804 reagent chamber using a plastic or glass ampoule or similar. In other implementations the reagents can be sealed or retained in the reagent chamber 804 using a sealed plastic or foil container that is perforated or otherwise broken by the shaft element 852. In some implementations, a portion of the 850 swab itself can contain all or a portion of one or more reagents. Sometimes, the reagent chamber 804 can be physically connected to the shaft element 852. In some implementations, the shaft element 852 is driven into the reagent chamber 804 when the chamber is attached to the probe assembly 800 by the user.
[0144] In one implementation, reagent chamber 804 is attached to shaft element 852 of test swab 850. After collecting a sample from the tip of swab 854, the test swab is inserted into conduit 810 in probe assembly 800. Male threads 818 in an outer portion of reagent chamber 804 engage female threads on the inner surface of the second cylindrical element 808. As the reagent chamber 804 is driven into the second cylindrical element 808 using threads 818, the shaft element 852 penetrates an ampoule containing the reagents, releasing the reagents into the conduit 810.
[0145] In another implementation, test swab 850 is separated from reagent chamber 804. After collecting a sample on swab tip 854, the test swab is inserted into conduit 810 in probe assembly 800. One or more flexible rings are arranged around the perimeter of the reagent chamber 804. One or more flexible rings provide a liquid-tight seal between the reagent chamber 804 and the inner surface of the second cylindrical element 808. As the user presses the reagent chamber 804 in the second cylindrical element 808, the shaft element 852 penetrates an ampoule containing the reagents, releasing the reagents into the conduit 810.
[0146] The first cylindrical element 806 is connected, threaded, joined or otherwise physically and fluidly attached to the optically transparent chamber 802. The conduit 810 extends the length of the first cylindrical element 806, providing a passage of central fluid through it. The size, shape and configuration of conduit 810 accommodates the passage of test swab 850, including shaft element 852 and swab tip 854. In some implementations, the first cylindrical element 806 may be an opaque material such as one or more thermoplastics (for example, ABS plastic) to minimize photon transmission by mounting probe 800 into darkroom 606. Although not shown in figure 8A, in some cases one or more identification or exclusive marks may be arranged on the outer surface of the first cylindrical element 806, for example, one or more printed, stamped or engraved logos, one or more trademark logos printed, stamped or engraved, or one or more machine-readable, printed, stamped or engraved bar codes, codes matrix, or the like.
[0147] The first cylindrical element 806 can have a perimeter or profile in uniform or non-uniform cross section. In one example, as illustrated in figure 8C, a first portion 812 of the first cylindrical element 806 may have a cross-sectional profile of an outer surface or perimeter in the shape of D 807, having a flat portion 807a and an arcuate portion 807b. although the first portion 812 may have a profile in non-circular cross section 807, the first portion 812 may also have a profile in circular cross section of internal surface 809, as illustrated in figure 8C. the profile in circular cross-section of internal surface 809 forms part of the conduit, is dimensioned and sized to receive a cotton swab in it. The first portion 812 can, for example, transition to a second portion 814 having a cross-sectional profile or circular perimeter of substantially similar diameter. The second portion 814 can, for example, transition to a third portion 816, having a circular perimeter of a larger diameter or cross-sectional profile than the second portion 814, for example, as illustrated in figure 8B.
[0148] The first cylindrical element 806 can be physically coupled to or integrally formed with the second cylindrical element 808.
[0149] The second cylindrical element 808 is disposed between the first cylindrical element 806 and the reagent chamber 804. One or more clamping devices 818, for example, threads, flexible friction collars, or similar devices, can be arranged in the chamber reagent 804, the inner surface of the second cylindrical element 808, or any combination thereof. In some cases, the clamping devices 818 may include one or more threads to threadably couple the reagent chamber 804 with the second cylindrical element 808. In other cases, the clamping devices 818 may include one or more flexible friction collars. for frictionally coupling the reagent chamber 804 to the second cylindrical element 808.
[0150] The second cylindrical element 808 can be a transparent or translucent material which advantageously allows visual observation of the flow of reagents in the conduit 810. The second cylindrical element 808 can have the same or different diameter or cross section than the first cylindrical element 806. For example, the second cylindrical element 808 may have a larger diameter than the third portion 816 of the first cylindrical element 806 as shown in figure 8.
[0151] Figure 9 shows an example 900 darkroom assembly, according to an illustrated embodiment. The darkroom assembly 900 includes a generally cylindrical intermediate section 902 having an opening 904 at a first end that is sized, shaped and configured to accommodate the insertion of a probe assembly 800. A substantially rectangular darkroom 906 is arranged at the distal end from the middle section 902. At least a portion of the darkroom 906 can be radiused to form a spherical or curved surface defining a concave surface 908 in the darkroom 906. The curved or spherical surface will have a central point 1310 (figure 13A). The substantially rectangular darkroom 906 may have a larger cross-sectional area than the generally circular intermediate section 902.
[0152] At least in some cases, the spherical or concave surface 908 is positioned at least partially in opposition to a photon detection assembly 910. One or more reflective surfaces or coatings may be arranged on at least a portion of the concave surface 908 such that the photons that reach the curved surface 908 are reflected towards the photon detection assembly 910. The reflection of photons emitted by a bioluminescent material placed in the darkroom 906 towards the photon detection assembly 910 can increase the overall accuracy or responsiveness of the 910 photon detection assembly.
[0153] The photon detection assembly 910 includes at least one photodiode that is communicatively coupled to a 914 transmitter. Preferably, the photon detection assembly 910 includes a set of avalanche diodes, in the form of a counter sensor of 912 multi-pixel photons. Photons emitted by bioluminescent material placed in the optically transparent chamber 802 enter darkroom 906 and fall on the 912 photodiode (s). Photons on the 912 photodiode (s) fall. provide an indication that biological matter (for example, adenosine triphosphate) is present in the optically transparent 802 chamber. The number and intensity of photons incident on photodiode (s) 912 provide an indication of the relative amount of biological matter present in the optically transparent 802 camera.
[0154] Although the 912 photodiode (s) provides a signal output related to the number and intensity of incident photons, the signal is of a sufficiently low level and quality to avoid direct transmission to the logic panel 502. In some cases, the signal provided by the photon detection assembly 910 is introduced into a communicatively coupled transmitter 914. The transmitter 914 can filter or amplify the electrical signal received from the photon detection assembly 910 to provide an output of signals having sufficient strength and quality for communication to logic panel 502. At least in some cases, signal output from transmitter 914 can be provided to at least one processor 504 in logic panel 502.
[0155] Obtaining an accurate, consistent and reproducible signal from the 910 photon detection assembly depends on multiple factors. Consistent and proper placement of each bioluminescent sample in the darkroom 906 can reduce variability attributable to the alignment or lack of alignment between the bioluminescent sample, the photon detection mount 910, and the curved or spherical surface 908. This is particular so that where the transparent portion of the probe assembly 800 and liquid retained in the same form or serve as an optical lens, for example, a cylindrical lens. The transparent portion 802 of the probe assembly 800 can advantageously be spaced from the photon detector 912 of the photon detection assembly 910 by a distance that at least approximately matches a focal length of the optical lens formed by the transparent portion 802 of the photon assembly. probe 800 and liquid retained in it. This can increase the detection of emitted photons. Reducing or eliminating scattered photons or incidents from entering the 906 darkroom can reduce noise in and improve the consistency of the signal provided by the 910 photon detection assembly.
[0156] To assist in properly positioning the optically clear camera 802 in the darkroom 906 and reducing the entry of scattered photons into the darkroom, one or more intermediate supports 916 can be positioned in the intermediate section 902 of the darkroom assembly 900. The supports intermediate 916 maintain proper lateral placement of probe assembly 800 in darkroom assembly 900 by coaxially aligning probe assembly 800 and darkroom assembly 900. Intermediate supports 916 can, in some cases, position the camera optically clear or substantially transparent 802 containing the bioluminescent sample at or near the focal point of the concave or spherical surface 908.
[0157] In some cases, an opening through which the probe assembly 800 is passed may penetrate some or all of the intermediate supports 916 in the intermediate section 902. In some cases, the intermediate supports 916 may share a common opening size, shape , configuration or position. In other cases, all or a portion of the intermediate supports 916 may have a different opening size, shape, configuration or position. The size, shape, configuration or position of the opening in each of the intermediate supports 916 may depend wholly or in part on the size, shape, configuration or position of the outer perimeter of the probe assembly 800 at the point where the probe assembly 800 passes through the opening . The intermediate supports 916 can be uniformly or non-uniformly distributed in the intermediate section 902. At least in one case shown in figure 9, two intermediate supports 916 can be positioned in the intermediate section 902 in locations that are closer to the darkroom 906 than the aperture 904.
[0158] At least in some cases, the openings in each of the intermediate supports 916 limit the orientation or position of the probe assembly 800 in the darkroom assembly 900. For example, the openings in each of the intermediate supports 916 can be in the form of D and the outer or outer surface of the first portion 812 of the first cylindrical portion of the probe assembly 806, 800, may have a cross-sectional profile in the form of a complementary D. In such a situation, probe assembly 800 can only be inserted into darkroom assembly 900 when the D-shaped portions of probe assembly 800 and aperture align. In addition to positioning probe assembly 800 on darkroom assembly 900, maintaining close tolerance between intermediate supports 916 and outer perimeter of probe assembly 800 advantageously reduces the intrusion of scattered photons into darkroom 906. Although the outer or outer surface of the first portion 812 of the first cylindrical portion of the probe assembly 806, 800 may have the profile in cross-section in the complementary D shape, an inner surface may have a profile in circular cross-section.
[0159] At least in some cases one or more darkroom brackets 918 may be arranged in darkroom 906. Darkroom brackets 918 locate the optically transparent chamber 802 of the probe assembly 800 laterally in darkroom 906. At least in in some cases, the darkroom brackets 918 may position the optically transparent chamber 802 in the darkroom 906 at or near the focal point of the spherical or curved surface 908. In addition to positioning the probe assembly 800 laterally, maintain a close tolerance between the aperture on the darkroom brackets 918 and the outer perimeter of the probe assembly 800 can further advantageously reduce or limit the intrusion of scattered photons into the darkroom 806.
[0160] A spring 920 or similar tension element can be disposed in the intermediate portion 902 of the darkroom assembly 900. The spring 920 can be retained in a desired position in the intermediate portion 902 using, for example, a collar 922 disposed at least partially around the inner surface of the intermediate portion 902. The spring 920 is useful in positioning the probe assembly 800 along the axial centerline of the darkroom assembly 900. Such an axial positioning can accurately and consistently position the optically transparent camera 802 in a desired axial location in the darkroom 906. Such positioning allows for substantially uniform photon measurement conditions on a sample-by-sample basis by reducing any variability associated with positioning the optically transparent chamber 802 in the darkroom 906. For example, spring compression 920 against collar 922 using probe assembly 800 can axially position the probe assembly near photodiode 912 in darkroom 906.
[0161] In some cases, the third larger diameter portion 816 of the first cylindrical element 806 may physically engage the spring 920 within the intermediate portion 902 in the darkroom assembly 900. For example, the larger diameter portion 816 of the first cylindrical element 816 can rest on the top of spring 920. In some cases, the increased diameter of the second cylindrical element 808 can physically engage the spring 920 within the intermediate portion 902 of the darkroom assembly 900. For example, the second cylindrical element 808 can rest on top of spring 920.
[0162] Figure 10 shows a system 1000 showing an example 800 probe assembly inserted into an example 900 darkroom assembly of an instrument. In the system 1000, the relationship between the darkroom 906, the optically transparent camera 802 and the photodiode (s) (for example, MPPC) 912 is visible. Specifically, as shown in figure 10, photons emitted by the bioluminescent sample and exiting of the optically transparent camera 802 fall directly on the photodiode (s) 912 or are reflected from the concave surface 908 of the darkroom 906 and are reflected back towards the photodiode (s) 912. As previously noted , the transparent portion of the probe assembly 800 and liquid contained therein may serve or function as a lens, focusing the bioluminescence towards the photodiode (s) 912 and achieving an advantageous synergistic effect. This may be true if the bioluminescence shifts directly towards photodiode (s) 912 without reflection or reflects from the reflective inner surface of the darkroom 906. The transmitter 914 in the photon detection assembly 910 generates and transmits a signal which is related to the quantity or intensity of the photons that reach the photodiode (s) 912.
[0163] In operation, the optically transparent camera 802 can be arranged close to photodiode (s) 912 partially or completely in the darkroom 906. The placement of the optically transparent camera 802 in the darkroom 906 and close to the photodiode (s) (s) 912 allows accurate and safe collection of photons emitted by the bioluminescent sample contained in the optically transparent chamber 802. The concave surface 908 can assist in the collection of photons emitted by the bioluminescent sample in the optically transparent chamber 802 by reflecting a portion of the photons emitted back towards the 912 photodiode (s). Providing a reflective surface on at least a portion of the concave surface 908 can further increase the efficiency, accuracy and reliability of the 912 photodiode (s) in the collection of photons emitted by the bioluminescent sample in the optically transparent chamber 802, as can the focus obtained by the optically transparent chamber 802 and the liquid contained therein.
[0164] Providing accurate, reliable and reproducible results depends at least in part on the proper lateral placement of the bioluminescent sample contained in the optically transparent portion 802 of probe assembly 800 in darkroom 906. One or more features, for example, one or more supports intermediates 916 can be positioned in the darkroom assembly 900 to make proper lateral placement of the probe assembly 800 and limit the entry of external scattered photons into the darkroom 906. In some cases, one or more darkroom brackets or clamps 918 it can also be arranged in the darkroom 906. Such darkroom brackets or clamps 918 can position the optically clear camera 802 in the darkroom 906. For example, one or more darkroom brackets or clamps 918 can position the optically clear camera 802 in the focal point of the curved surface 908.
[0165] After insertion into the darkroom assembly 900, the probe assembly 800 compresses the spring 920. The spring 920 can help to keep the camera optically transparent 802 in a suitable axial alignment with photodiode 912 in the darkroom 906. At least in some cases, the first cylindrical section 806 can compress the spring 920. In other cases, the second cylindrical section 808 can compress the spring 920.
[0166] A cover assembly 1002 can be pivotally, slidably, threaded or similarly displaceable to the system 100, 200, 300, 400. At least in some cases, cover assembly 1002 can be operatively coupled to the top of the housing 122, 222, 322, 422. Cover assembly 1002 may have one or more locks or similar mechanical or electromechanical devices to maintain cover assembly 1002 in one or more desired positions, for example, an open position exposing at least a portion of the darkroom assembly 900, or a closed position covering at least a portion of the darkroom assembly 900.
[0167] The cover assembly 1002 may, in some cases, be used individually or in combination with one or more other systems or devices to attach the probe assembly 800 to the darkroom assembly 900. When in the closed position, the cover assembly 1002 can advantageously assist in limiting the entry of scattered photons of light from the environment for the darkroom assembly 900. In some cases, cover assembly 1002 may include a hinged door that rotates around one or more joints after probe assembly 800 is placed in darkroom assembly 900. In other cases, cover assembly 1002 may include a sliding door that is displaceable across one or more channels after probe assembly 800 is placed in the 900 darkroom mount.
[0168] The cover assembly 1002 can keep the spring 920 in compression while the probe assembly 800 is arranged in the darkroom assembly 900. In some cases, the cover assembly 1002 may have one or more projections 1004. One or more projections 1004 may be useful, for example, in exerting additional pressure on probe assembly 800, thereby assisting in the proper positioning of probe assembly 800 on darkroom assembly 900. In other cases, one or more projections 1004 may displace reagent chamber 804 stops over test swab 850, breaking one or more ampoules located on or frangible membranes located through reagent chamber 804. In some cases, compression of spring 920 may provide an indication for system 100, 200 , 300, 400 that a probe assembly 800 has been inserted and the photon detection assembly 910 must be energized. In other cases, placing the cover assembly 1002 in a closed position can provide an indication to the system 100, 200, 300, 400 that a probe assembly 800 has been inserted into the darkroom assembly 900.
[0169] At least in some cases, opening the cover assembly 1002 can assist in removing the probe assembly 800 from the darkroom assembly 900 by releasing the compressive force on the spring 920. After releasing the compression the spring 920 can return to an uncompressed position, providing an upward force on probe assembly 800 that tends to "lift" the probe assembly from the darkroom assembly 900.
[0170] Figure 11 shows a portion of a system 1000 including an example 800 probe assembly inserted into an example 900 darkroom assembly. Intermediate brackets 916 in the neglected chamber assembly 900 hold probe assembly 800 in one position more or less coaxially centered in the middle section 902 and in the darkroom 906. The optically transparent chamber 802 is maintained substantially in the focus of the concave or spherical surface 908 by the darkroom brackets 918. The compression of the spring 920 against the collar 922 inside the intermediate section 902 longitudinally positions the optically transparent chamber 802 in the darkroom 906. The spring 902 is held in compression by the cover assembly 1002 and the projection 1004, both of which prevent upward displacement of the probe assembly 800 in the darkroom assembly 900 .
[0171] Proper placement of probe assembly 800 in darkroom assembly 900 advantageously allows substantially all of the photons emitted by the bioluminescence of the biological sample in the optically transparent chamber 802 to fall on the 910 photon detection assembly, and ensure the effect advantageously synergist of the optically transparent chamber 802 and the liquid contained therein. In such a way that the 910 photon detection assembly is capable of providing an accurate, reliable and reproducible signal that is related to the number and intensity of the incident photons. The relatively tight fit between the intermediate supports 918 and the first cylindrical element 906 and the darkroom supports 818 and the optically transparent chamber 902 reduces the likelihood of external photons entering the darkroom and affecting the accuracy of the photon detection assembly 810.
[0172] At least in some cases, one or more identifiers may be arranged in whole or in part in the first cylindrical element 806. These identifiers may include in a varied way one or more stamped, engraved or printed designs, stamped, engraved or printed trademarks , stamped, engraved or printed trade names, machine-readable, embossed or printed bar symbols (for example, one-dimensional or barcode symbols, area or matrix or two-dimensional code symbols) or combinations thereof. Although not shown in figure 11, at least in some cases, a reader (for example, a set of photodiodes) or similar device can be arranged near the probe assembly 800 to "read" or otherwise convert one or more identifiers to the assembly of probe 800 on one or more electronic signals. Such electronic signals can be compared with reference signals stored in the non-transitory storage medium 506 and are useful, for example, in detecting the type of probe assembly 800 used, detecting the type and quantity of reagent in the reagent chamber 804, detecting compatibility of probe mount 800 with photon detection mount 910, detect whether probe mount 800 conforms to the requirements of the manufacturer or distributor, detect whether probe mount 800 is genuine and similar. This can be critical to ensure that the probe mount 800 aligns correctly with the optimum (for example, reflective spherical inner surface, lenses, filters) and / or 912 photodiode (s).
[0173] Figure 12 shows the probe assembly 800 positioned in the darkroom 906. The physical relationship and proximity between the optically transparent camera 802, the photodiode (s) 912 and the darkroom 906 is evident in figure 12. The swab tip 854 contains the biological sample and can in some cases be positioned in the optically transparent chamber 802. The reagent from the reagent chamber 804 at the opposite end of the test swab assembly 800 flows along the shaft element 852 and mix with the biological sample on the tip of the swab 854. The reagent causes one or more compounds present in the biological sample to perform bioluminescence. As a consequence of the sample's bioluminescence, photons of light are emitted from the optically transparent portion 802. The emitted photons fall on the photodiode (s) (for example, MPPC) 912, causing the (s) ) photodiode (s) 912 transmit a signal proportional to the number and intensity of the incident photons to transmitter 91. In turn, transmitter 914 filters and amplifies the signal to generate and transmit a signal proportional to the amount or intensity of photons incident on the photodiode (s) 912 for one or more external devices such as at least one 504 processor.
[0174] Figure 13A shows a spherical darkroom 1300 having an inner reflective hemispherical curved surface 1304 that forms an interior 1302. Photons 1306 generated by the bioluminescent sample 1308 in the optically transparent chamber 802 are shown as scattered lines coming out of the optically transparent chamber 802 and reflecting off the reflective inner surface 1304 of the wall (s) of the spherical darkroom 1300.
[0175] The spherical darkroom 1300 includes one or more receiver openings of probe mount or sample holder 1320a, 1320b (collectively 1320) sized to receive an optically transparent chamber portion 802 from a probe mount or sample holder 800. As illustrated, the spherical darkroom 1300 includes two such receiving openings 1320a, 1320b, diametrically opposed to each other through a diameter or center point 1310 of the reflective inner surface 1304 of the spherical darkroom 1300. In other implementations, the darkroom spherical 1300 may include a single receiving aperture 1320a, for positioning a distal tip 803 of the optically transparent chamber portion 802 of the probe assembly or sample holder 800 in the cavity or interior 1302 during use.
[0176] Notably, the receiving openings 1820a, 1820b or opening 1820a are arranged to position the optically transparent portion 802 to pass through the central point 1310 of the reflective inner surface 1304 of the spherical darkroom 1300 to orient and / or focus lighting on towards an opening of detector 1822 and associated photodiode (s) 912. This can not only direct the illumination on or on the photodiode (s) 912, but can also advantageously be used as a fluid contained in it as a lens cylindrical to focus illumination on or in photodiodes 912. As illustrated in figure 13A, a portion of the photodiodes 912 or associated detector assembly can project into the interior 1302 of the spherical darkroom 1300 through detector opening 1822. In other implementations, photodiodes 912 or associated detector assembly can be fully located externally from inside 1302, detector opening 1822 allowing light transmission nation through to opening 1822 photodiodes 912 or associated detector assembly. This can pass through a window or lens at the 1822 detector opening.
[0177] Photodiode (s) (for example, MPCC) 912 is (are) shown (s) positioned (s) close to the spherical darkroom 1302. Photons leaving the interior 1302 of the darkroom 1300 reach the photodiode (s) 912. Although several example darkrooms (for example, cylindrical, spherical) have been described above, a darkroom having any geometry capable of reflecting at least a portion of the 1306 photons emitted by a sample bioluminescent 1308 for photodiode 912 can be replaced. For example, one or more parabolic surfaces, one or more faceted surfaces, or one or more segmented surfaces can be used to form all or a portion of the darkroom 1302. Spherical internal surfaces are particularly desirable.
[0178] The various modalities described above combine the ability to accurately, precisely and efficiently measure the bioluminescence of a sample collected from a surface in an installation subject to HACCP requirements. The bioluminescence of the sample is measured using the 910 photon detection assembly, and data associated with the sample (eg, date, time, location, test results, etc.) is stored on the 506 non-transitory storage media for further communication to one or more external devices or networks. The advantages of such a system are evident, particularly in the food industry where HACCP-based standards are prevalent and the use of bioluminescence as a means to assess biological contamination of surfaces is accepted and very relevant. To comply with HACCP guidelines, a food processor or food manufacturer must be able to identify critical control points (“CCPs”) in their processes. CCPs are points, steps or procedures where some form of control can be applied and a risk to food safety can be reduced or eliminated. The processor or manufacturer may need to measure a variety of parametric indicators for each CCP (for example, measurements of temperature and time to verify a cooking process), identify deviations from statistically acceptable ranges, perform trend analysis of such deviations, and document the data to show corrective actions taken in accordance with the HACCP guidelines. The capacity of the 100, 200, 300, 400 system to increase the accuracy, reliability and reproducibility not only of bioluminescence measurements, but the inherent record keeping associated with data collection is therefore highly desirable.
[0179] One way to increase accuracy, reliability and reproducibility is by providing the sample collection and analysis system with the ability to identify a probe assembly 800 inserted in the 900 darkroom assembly. The provision of a machine-readable identifier on probe assembly 800 allows the sample collection and analysis system to verify or authenticate probe assembly 800. Verification or authentication of probe assembly 800 can provide a degree of assurance that probe assembly 800 is both physically and chemically compatible with the sample collection and analysis system. Physical compatibility is important, for example, to ensure a tight fit of probe assembly 800 on intermediate supports 916 to limit the intrusion of scattered photons into the 906 darkroom. Chemical compatibility is important, for example, to ensure that the lengths of wave of photons emitted by the bioluminescent sample are within the sensitivity range of photodiode (s) 912 of the photon detection assembly 910. By providing the user with assurances that the probe assembly 800 is both physically and chemically compatible with the sample collection and analysis system, user confidence is increased and the overall quality of the HACCP program is improved. Such identification can provide the user with a quality assurance that the probe assembly 800 used with the sample collection and analysis system is approved for use by the system distributor or manufacturer, and that the probe assembly 800 is not counterfeit or otherwise inferior to products supplied by the manufacturer or distributor.
[0180] In response to the detection of an authorized probe assembly 800 that is physically and chemically compatible with the sample collection and analysis system, the system can enter a normal operating mode by reading the bioluminescence of the sample 1308 contained on probe assembly 800. Test results can be reported via user interface 102 and stored together with any associated location, time and date data in non-transitory storage medium 506. In response to the detection of an unauthorized probe assembly 900, for example, a probe assembly that is counterfeit or physically or chemically incompatible with the sample collection and analysis system, the system may display an indicator on user interface 102 indicating that the 900 probe assembly is incompatible with the system , and can inhibit the bioluminescence reading of the sample contained in the 900 probe assembly. Such a system can also be used to deter harmful use of the collection and analysis system. sample lysis, for example, using the same probe assembly 800 for a number of different HACCP test points.
[0181] System 100, 200, 300, 400 can identify the identity, physical construction or chemical composition of probe assembly 800 using one or more methods, including optical scanning of identification marks on probe assembly 800 or scanning of radio frequency to identify electronic devices in probe assembly 800. Figures 14A and 14B show several circuit panels, each containing an example electronic scanning device 1402a, 1402b useful in scanning and identifying one or more electronic identifiers loaded by probe assembly 800 In some cases, such electronic scanning devices 1402 may generate one or more radio frequency interrogation (RF) signals to interrogate a radio frequency identification tag (RFID) or similar electronic transponder that is attached to or incorporated into the probe assembly 800 Data returned to the electronic scanning device 1402 in the form of an RFID or electronic response signal may include r items such as an authentication code, physical dimensions of probe assembly 800, and reagents present in probe assembly 800. In other cases, electronic scanning devices 1402 can transmit one or more data streams or codes to an electronic tag built into probe assembly 800 and monitor the response from the electronic tag to verify or authenticate probe assembly 800 to the system. Since probe assembly 800 is visible electronically to electronic scanning device 1402, the scanner can be flexibly positioned in housing 104, 204, 304, 404, for example, in a location that is nearby, but not necessarily integrated with the 900 darkroom assembly.
[0182] Figure 15A shows an example of an optical scanning device 1502 capable of reading an authenticator 1504 illustrated in figure 15B. authenticator 150 can be loaded onto a surface of probe assembly 800. At least in some cases, the authenticator can be engraved, stamped, printed or otherwise inscribed or applied to or on the flat portion of the first portion in the form of D 812 probe assembly 800.
[0183] Optical scanning device 1502 may include a set of photos configured to read electromagnetic radiation reflected from a recorded, stamped, printed or otherwise inscribed or applied audio device (eg, trademark, trade name, logo) carried over the surface of probe assembly 800 as authenticator 1504 passes close to optical scanning device 1502. At least in some cases, the electromagnetic radiation used to illuminate authenticator 1504 can be integral with or arranged close to the optical scanner 1502 to illuminate the authenticator 1504 in the probe assembly 800. At least in some cases, the accuracy or resolution of the optical scanner 1502 can be enhanced or otherwise increased by placing one or more auto-focus lenses (eg, SELFOC® lenses from the GoFoton® Group) between the optical scanning device 1502 and the authenticator 1504.
[0184] Optical scanning device 1502 converts authenticator 1504 into an electronic signal by reading the electromagnetic radiation reflected by authenticator 1504. The electronic signal provided by optical scanning device 1502 can be compared with one or more reference signals to determine whether a substantial similarity between the electronic signal provided by the optical scanning device 1502 and at least one of the reference signals. In such a way that the optical scanning device 1502 is capable of electronically "reading" and "identifying" an authenticator loaded by the probe assembly 800.
[0185] The use of an optical scanner 1502 requires at least a partial line of sight between the optical scanner 1502 and the authenticator 1504. As a consequence, the optical scanner 1502 can be arranged at least partially in a door or similar opening that is formed in the darkroom assembly 900. In some cases, the optical scanner 1502 may be arranged external to the darkroom assembly 900, for example, the optical scanner 1502 may be arranged external to the opening 904 defining the entrance to the darkroom assembly 900 and close to the probe insertion door 118.
[0186] In at least one case, the optical scanning device 1502 can be positioned in an opening in the darkroom assembly 900 such that the first portion 812 of the first cylindrical element that carries the authenticator 1504 passes before the scanning device optical 1502 as probe assembly 800 is inserted into darkroom assembly 900. In other cases, optical scanner 1502 can be positioned in an opening in darkroom assembly 900 such that authenticator 1504 is opposite to the optical scanning device 1502 when the probe assembly 800 is positioned in the darkroom assembly 900, for example, after the cover assembly 1002 is placed in a "closed" position.
[0187] Figure 16 shows an example infrared scanning device 1602 capable of reading an authenticator printed on a responsive infrared media on the surface of the probe assembly 800. The infrared scanning device 1602 can include one or more infrared emitters and one or more detectors that are able to illuminate an authenticator printed on the probe assembly 800 with electromagnetic radiation in the infrared spectrum. A portion of the infrared light is reflected back to the detector, which converts the infrared light reflected by the authenticator printed on the probe assembly 800 into an electronic signal. The authenticator printed on the surface of the probe assembly 800 may include, but is not limited to, a trade name, a trademark, a bar code, an area code or matrix, or the like.
[0188] The signal provided by the infrared scanning device 1602 carries indicative data from the printed authenticator on probe assembly 800. The signals returned from substantially similar printed authenticators must themselves be substantially similar. One or more reference signal profiles stored, for example, on the non-transitory storage media 506 can therefore be used to verify or authenticate the signal read by the infrared scanning device 1602 from the authenticator printed on the probe assembly 800. In in some cases, at least one processor 504 can compare the signal provided by the infrared scanner 1602 with one or more stored reference signal profiles to determine whether the signal provided by the infrared scanner 1602 matches substantially with one or more signal profiles stored reference points. The presence of a reference signal profile match can authenticate the probe assembly 800.
[0189] The use of an infrared scanning device 1602 requires at least a partial line of sight between the infrared scanning device 1602 and the printed authenticator on probe assembly 800. As a consequence, the infrared scanning device 1602 can be arranged by the least partially in a door or similar opening that is formed in the darkroom 900 assembly. In some cases, the infrared scanner 1602 can be arranged external to the darkroom 900 assembly, for example, the infrared scanner 1602 can be external arrangement to opening 904 defining the entrance to the darkroom assembly 900 and close to the probe insertion door 118.
[0190] In at least one case, the infrared scanning device 1602 can be positioned in an opening in the darkroom assembly 900 such that the first portion 812 of the first cylindrical element carrying the printed authenticator passes before and is illuminated by infrared infrared scanner 1602 as probe assembly 800 is inserted into darkroom assembly 900. In other cases, infrared scanner 1602 can be positioned in an opening in darkroom assembly 900 such that the Authenticator printed on probe assembly 900 is opposite to infrared scanning device 1602 when probe assembly 800 is positioned on darkroom assembly 900, for example, after cover assembly 1002 is placed in a "closed" position.
[0191] The use of electronic signals provided by electronic scanning devices 1402, optical scanning devices 1502, infrared scanning devices 1602 or combinations thereof, to identify and authenticate a probe assembly 800 by comparison with one or more signals reference, it advantageously allows periodic updates and renewals of a reference signal library containing one or more reference signals that is stored on the 506 non-transitory storage media. Such updates and renewals of the reference signal library can be provided electronically, by example, over the Internet for synchronizing the sample collection and analysis system with an external device connected to the Internet. Such updates and renewals of the reference signal library can be provided as software, for example, on a non-transitory, removable storage medium (for example, secure digital cards, flash drives, and the like) that are communicatively attachable to the collection system. and sample analysis.
[0192] In addition, the use of electronic signals to verify or authenticate the probe assembly 800 can also improve tracking and accounting capabilities in an HACCP program by allowing the association of a specific probe assembly 800 with a specific test result . Electronic signals can also be used for other purposes, for example, a reagent expiration date can be coded on a probe assembly 800 containing an integral reagent chamber. Such uses can increase confidence in the results obtained and help to ensure the accuracy of the HACCP records generated using the sample collection and analysis system.
[0193] Figure 17 shows an example 1700 sample collection and analysis system. Figure 17 shows physical and spatial arrangements of the various parts, components, systems, and devices described in detail above. For example, the front portion of the housing 160, 206, 306, 406 and the rear portion of the housing 108, 208, 308, 408 are shown separately, making visible several alignment tongues 1702 and threaded fasteners 1704 useful in physically aligning and couple the front portion with the rear portion to form the housing 104, 204, 304, 404. Also shown in figure 17 is a two-piece darkroom assembly 900. An opening 1706 accommodating a scanning device (for example, a scanning device) electronic scan 1402, optical 1502, or infrared 1602) is visible in the middle section 902 of the darkroom assembly. The darkroom assembly 900 shown in figure 17 includes an example spherical darkroom 906. A multi-piece logic panel 502 is shown in figure 17. At least one of the logic panels 502 can include one or more communication interfaces 1708 which physically align with one or more communication ports 114 which in the housing shown in figure 17 are located at the rear portion 108, 208, 308, 408.
[0194] The heatsink 612 shown in figure 17 includes two thermally conductive elements. The first thermally conductive element is an extended surface, that is, a finned heat transfer device that passively, convectively, transfers heat to the environment around the first thermally conductive element. The second thermally conductive element is a thermally conductive toroidal element which is arranged around the photodiode (s) (e.g., MPPC) 912 and thermally conductively coupled to the first thermally conductive finned element. Heat generated by 912 photodiodes is transferred by conduction and convection to the second toroidal element and then transferred through conduction to the first thermally conductive element. These elements constitute at least a portion of a thermal management subsystem that can include passive (for example, ends, pins) and / or active (for example, fans, electric coolers) components or heat transfer elements.
[0195] A two-piece housing top 122, 222, 322, 422 is shown in figure 17. Probe insertion door 118 is visible at the top of the housing. Cover assembly 1002 includes a hinged door and a torsion spring 1712 to keep the hinged door in an open position when the hinged door is pivoted away from the probe insertion door 118. Maintaining the hinged door in an open position can assist in passing the probe assembly 800 into the 900 darkroom assembly.
[0196] Figure 18 shows a selection test point through the 1802 scrolling screen of a graphical user interface according to an illustrated modality, which can be presented through a processor on a display, for example, a display of touch screen, a portable monitoring instrument such as those described above.
[0197] The selection test point via the 1802 scrolling screen displays for selection by an end user a number of test point identifiers 1804a-1804n (two evoked, collectively 1804) for respective test points. The test points and associated test point identifiers can be defined by the end user, company or some other entity. As illustrated, test point identifiers 1804 can be presented as a list. Test point identifiers 1804 may be in the form of a test point number 1806 (one evoked) and / or a recognizable human description or name of test point 1808 (one evoked). selecting and dragging an 1810 user selectable scroll icon allows a user to scroll through the list of 1804 test point identifiers in a current window or page, allowing identification and selection of a desired test point identifier 1804 (for example, test point number 1806, description or test point name 1808). The currently identified test point identifier 1804 is visually distinguished, for example, by highlighting 1812. A user entry, for example, a single tap or double tap, selects the identified test point identifier 1804.
[0198] Selecting one of a pair of user selectable page icons 1814a, 1814b (collectively 1814) causes additional windows or pages of test point identifiers 1804 to appear. The pages or windows can include point identifiers 1804 test for the same process or for different processes, which may or may not be related to one or the other. Test point identifiers 1804 can be logically grouped together on different pages or windows, for example, test identifiers 180 can be grouped corresponding to a respective location, system, subsystem or portion of a process, collectively referred to as zones. For example, a food manufacturing process can be logically divided or segmented into several processes, for example, preparing raw ingredients, mixing ingredients, cooking, cooling, quality assurance, and packaging, each identified as a respective zone. Each segment or zone can be associated with respective equipment, work surfaces and / or personnel, and each assigned a respective page or window with one or more test points. In this way, multiple pieces of equipment associated with mixing can be assigned multiple test points and associated test point identifiers 1804 to a given zone grouped together on a common page or windows. Selecting a left-facing arrow head 1814a can result in a set of 1804 test point identifiers associated with a first zone that, for example, occurs earlier in the food preparation manufacturing process, while selecting a right-pointing arrow head 1814b can cause a set of 1804 test point identifiers associated with a second zone that occurs later in the food manufacturing or preparation process. Previous steps or operations can be assigned lower or lower test point numbers 1806, while later steps or operations can be assigned higher or higher test point numbers 1806. Test point numbers may reflect the zones with which the associated tests are grouped. For example, zones can be identified by digits to the left of a decimal point and / or digits to the right of the decimal point. One or more test points can be associated with a respective zone of the zones. Several groups of sets and sub-sets can be identified using places in a multi-digit test point identifier number.
[0199] The selection test point through the 1802 scrolling screen includes an 1816 test type indicator that indicates a type of test being performed. For example, as illustrated, an ATP indication is displayed indicating that an ATP test must be performed. Selecting an 1818 user selectable test selection icon allows the user to select other tests, for example, pH, temperature, pressure, dissolved gases, conductivity, reduction potential, and / or specific ions.
[0200] The selection test point through the 1802 scrolling screen may include an 1820 test point input box, the selection of which causes the display of a virtual key block or virtual keyboard (not shown). The user can then switch to a 1804 test identifier, and select an enter key to select the desired test point.
[0201] The selection test point via the 1802 scrolling screen may include an 1822 quick test user selectable icon, the selection of which performs a quick test.
[0202] The selection test point via the 1802 scrolling screen may include a new test point user selectable icon 1824. User selection of the new test point user selectable icon 1824 may cause a display to appear. new test point creation window. This allows the end user to create new test points and associated test point identifiers 1806, 1808.
[0203] The selection test point via the 1802 scroll screen can include a navigation bar with a number of user selectable icons to allow navigation to various modes and associated windows or pages. For example, the navigation bar can include an 1826 test plan user selectable icon, an 1828 test point user selectable icon, an 1830 data user selectable icon, and an 1832 device user selectable icon. currently selected mode or page or window can be visually distinguished, for example, by highlighting as illustrated.
[0204] Figure 19 shows a selection test point through the 1902 input screen of a graphical user interface according to an illustrated modality, which can be presented through a processor on a display, for example, a display of touch screen, from a portable monitoring instrument such as those described above. The selection test point via the 1902 input screen has a number of constructions or elements that are identical or similar to those of the selection test point via the 1802 scroll screen. Identical or similar elements or constructions (for example, icons selectable by user, menus, indicators, scrollbars and controls) are identified using the same reference numbers as set out above, and discussion of those elements is not repeated in the interest of brevity. Only significant differences are discussed below.
[0205] The selection test point via the 1902 entry screen includes a virtual key block 1904 that allows the user to enter a 1804 test point identifier in the 1820 test point entry box. The user simply touches the screens user-selectable virtual keys 1904a-1904n (twelve shown, only two evoked) as desired to enter a 1804 test point identifier. As illustrated, virtual key block 1904 includes virtual keys 1904a- 1904n corresponding to the digits 0-9 and arrows left and right pages, allowing entry of a 1806 test point number (figure 18) or scrolling to different pages. Alternatively, the virtual key block 1904 may display alpha or other characters and may include a greater or lesser number of virtual keys. The virtual key block 1904 can be context sensitive, for example, displaying different alphanumeric characters or other characters based on the context. Optionally, the selection of 1814 user-selectable page icons or left and right arrow soft keys may cause different virtual key blocks to be displayed.
[0206] Figure 20 shows a screen of 2002 test results from a graphical user interface requiring a result of moving to a test zone according to an illustrated modality, which can be presented through a processor on a display, for example. example, a touch screen display, a portable monitoring instrument like those described above. The 2002 test results screen has a number of constructs or elements (for example, user-selectable icons, menus, indicators, scrollbars and controls) that are identical or similar to those of the selection test point via the scrolling screen 1802 (figure 18). Similar or identical elements are identified using the same reference numbers as explained above, and discussions of those elements are not repeated in the interest of brevity. Only significant differences are discussed below.
[0207] The 2002 test results screen displays results for a test. The results include an easy to recognize 2004 visual indication of the results, in this case a large circle with the description “APPROVED” and an identification of a zone with which the specific test point is associated. The test results are further emphasized by color, for example, using the color green to indicate an approval result.
[0208] The 2002 test results screen can also include a set of test results details. These may include an indication of the test point number 2006, test point name 2008, a value of a code 2010, limit values (for example, alert limit 2012, failure limit 2014) and an indication 2016 if the retest must be performed.
[0209] Figure 21 shows a screen of test results 2102 from a graphical user interface showing an alert result for a test zone according to an illustrated modality, which can be presented through a processor on a display, for example example, a touch screen display, a portable monitoring instrument like those described above. The test results screen 2102 has a number of elements or constructions (for example, user-selectable icons, menus, indicators, scroll bars and controls) that are identical or similar to those of the test results screen 202. Elements or constructions similar or identical are identified using the same reference numbers as explained above, and discussion of these elements is not repeated in the interest of brevity. Only significant differences are discussed below.
[0210] The test results screen 2102 displays results for a test. The results include an easy to recognize 2102 visual indication of the results, in this case a large square with the description “WARN” and an identification of a zone with which the specific test point is associated. The test results are further emphasized by color, for example, using yellow to indicate a marginal result.
[0211] Figure 22 shows a screen of test results 2202 from a graphical user interface showing a failure result for a test zone according to an illustrated modality, which can be presented through a processor on a display, for example. example, a touch screen display of a portable monitoring instrument like those described above. The 2202 test results screen has a number of elements or constructs (for example, user selectable icons, menus, indicators, scroll bars and controls) that are identical or similar to those of the 2002 test results screen. Similar elements or Identicals are identified using the same reference numbers as explained above, and discussion of those elements is not repeated in the interest of brevity. Only significant differences are discussed below.
[0212] The test results screen 2202 displays results for a test. The results include an easy to recognize 2204 visual indication of the results, in this case a large hexagon with the description “FAILED” and an identification of a zone with which the specific test point is associated. The test results are further emphasized by color, for example, using the color red to indicate a failure result.
[0213] Figure 23 shows a 2302 instrument panel screen of a user interface according to an illustrated modality, which can be presented on a display through a computer system processor, communicatively coupled to a monitoring instrument. portable as those described above. The 2302 instrument panel display provides a convenient way for a user to examine test and compliance, and interact with one or more pieces of portable monitoring equipment.
[0214] The 2302 instrument panel screen includes a 230 menu bar of user selectable icons. Selecting a user selectable icon from a 2306 file allows the user to save a file, select an existing file, or create a new file. Selecting a user-selectable icon to view raw data 2308 causes raw data to be presented, and optionally a raw data user interface, to the user. Selecting an MVP 2310 user-selectable icon allows the user to select a specific portable monitoring instrument for reporting and / or calibration. Selecting a user selectable icon from 2312 options presents a list of user selectable options. Selecting a 2314 support user selectable icon gets support for the user. This may include accessing a user guide, a list of frequently asked questions, and / or contacting user support personnel via e-mail (eg e-mail) or a voice line.
[0215] The 2302 instrument panel display also includes a 2316 indication of an identity for a currently communicatively coupled piece of portable monitoring equipment. The user's selection of a 2317 user-selectable decoupling icon ends the communicative coupling with the piece of portable monitoring equipment. The 2302 instrument panel screen also includes a 2318 indication of an identity of a currently open file in which the information is saved.
[0216] A set of user-selectable navigation icons allows the user to navigate between various modes and associated windows or pages. For example, selecting a user-selectable 2320 test report icon provides detailed test reports to the user, optionally with a test report user interface to allow navigation between and within selected test reports, and / or edit reports of test. Selecting a user selectable icon from ATP 2322 usage reports provides detailed usage reports to the user, optionally with a usage reporting user interface to allow navigation between and within selected ATP usage reports and / or editing reports use of ATP. Selecting a user selectable icon for HACCP 2324 compliance reports provides detailed HACCP compliance reports for the user, optionally with a HACCP compliance reporting user interface to allow navigation between and in selected HACCP compliance reports , and / or edit HACCP compliance reports. Selecting a 2326 test point configuration user user selectable icon causes a test point configuration user interface to be presented to the user, allowing the user to configure new test points, modify existing test points and / or delete existing test points.
[0217] The 2302 instrument panel screen includes a number of simplified information display boxes for presenting summaries of key information.
[0218] Information display boxes may include a 2328 test run box that provides a 2328a indication of a total number of tests (for example, ATP swabs) performed for a current period (for example, monthly) as well as an indication 2328b of a total target number of tests for the current period. A color can be used to signify or emphasize a status, for example, green where comprised of an acceptable limit or value of tests has been performed, red where outside an acceptable limit or value of tests have been carried out, and yellow or magenta where marginal or borderline the limit or acceptable value of the number of tests has been carried out. Selecting a 2328c user-selectable report icon causes a report to be displayed detailing the tests performed.
[0219] Information display boxes can include a 2330 alert result box that shows a 2330a indication of a percentage of tests (for example, ATP swabs) that resulted in a defined condition or result (for example, alert) for an identified period (for example, January 1 - June 1) 2330b. Again, a color can be used to signify a status, for example, green where comprised at the limit or acceptable value of a percentage of tests resulting in an alert result, red where outside a limit or acceptable value at a percentage of tests resulting in an alert result, and yellow or magenta where marginal or borderline the limit or acceptable value of a percentage of tests resulting in an alert result. Selecting a 2330c user-selectable report icon causes a report to be displayed detailing alert results.
[0220] Information display boxes can include a 2332 failure result box that shows a 2332a indication of a percentage of tests (for example, ATP swabs) that resulted in a defined result or condition (for example, failure) for an identified period (for example, January 1 - June 1) 2332b. Again, a color can be used to signify a status, for example, green where comprised of a limit or acceptable value of a percentage of tests resulting in a failure result, and where outside a limit or acceptable value of a percentage of tests resulting in a failure result, and yellow or magenta where marginal or borderline the limit or acceptable value of a percentage of tests resulting in a failure result. Selecting a 2332c user-selectable report icon causes a report to be displayed detailing failure results.
[0221] Information display boxes can include a 2334 calibration box that shows a 2334a indication of a date that a piece of portable monitoring equipment was last calibrated and a 2334b indication of a next date to calibrate the portable monitoring equipment, for example, in the form of a number of days left until the next scheduled calibration. Again, a color can be used to signify a status, for example, green where it is within an acceptable time limit or value from the last calibration, red where it is outside an acceptable time limit or value from the last calibration, and yellow magenta where marginal or borderline the acceptable limit or value of a time from the last calibration. Selecting a 2334c user-selectable report icon causes report display detailing calibration records.
[0222] The 2302 instrument panel screen includes a number of graphs or simplified diagrams to present graphical summaries of key information.
[0223] Graphs or diagrams may include a 2336 graph or diagram of cleaning effectiveness (%) per test point. This can indicate effectiveness along one axis 2336a, with several test points displayed along another axis 2336b. Again, color can be advantageously employed to visually distinguish or emphasize between conditions, for example, green indicating very effective cleaning, yellow marginally effective cleaning and red indicating ineffective cleaning.
[0224] Graphs or diagrams can include a 2338 graph or diagram of cleaning effectiveness (%) per sampling plan. This can include effectiveness along one axis 2338a, with several items in a sampling plan displayed along another axis 2338b. Again, color can be advantageously employed to visually distinguish or emphasize between conditions, for example, green indicating very effective cleaning, yellow marginally effective cleaning and red indicating ineffective cleaning. Selecting a 2338c user-selectable report icon can cause plan sampling cleaning efficacy to show.
[0225] Graphs or diagrams may include a 2340 graph or diagram of retest effectiveness (%) per test point. This can indicate effectiveness along a 2340a axis showing the percentage of pass, alert and failure results, with several test points displayed along another 2340b axis. Again, color can be advantageously employed to visually distinguish or emphasize between conditions, for example, green indicating a conformity value, yellow indicating a marginally conforming value that is close to non-conformity, and red indicating a non-conformity value.
[0226] A 2342 window scroll bar allows a user to scroll up and down in the 2302 instrument panel screen window.
[0227] Figure 24 shows a 2402 raw data screen of a user interface according to an illustrated modality, which can be presented on a display through a computer system processor, communicatively coupled to a portable monitoring instrument. like those described above. The 2402 raw data screen has a number of elements or constructions (for example, user-selectable icons, menus, indicators, scroll bars and controls) that are identical or similar to those on the 2302 instrument board screen (figure 23). Similar or identical constructions or elements are identified using the same reference numbers as set out above, and discussion of those elements is not repeated in the interest of brevity. Only significant differences are discussed below.
[0228] The raw data screen 2402 includes a raw data table or graph 2404 to present raw data for various test points and associated information. The raw data screen 2402 also includes a number of user selectable raw data tabs 2406a-2406c (five shown, collectively 2406), which a user can select to determine which type of raw data is shown in the raw data table or graph. 2404. For example, raw data screen 2402 may include an ATP raw data tab 2406a, pH raw data tab 2406b, raw temperature data 2406c tab, raw conductivity data tab 2406d, raw data tab of PPM 2406e. A currently selected raw data tab 2406a can be visually indicated or emphasized, for example, through highlighting or a color change.
[0229] Raw data can, for example, be presented in rows and columns. For example, figure 24 illustrates the presentation of raw ATP data, each row 2408a-2408n (only two evoked) corresponding to a respective test point. The columns can include a test point number column 2410 that identifies the test point by the test point number. A 2412 point name column can identify the test point by the test point name. A sampling plan column 2412 can identify a portion of a sampling plan to which the raw data refer. A date column 2416 and a time column 2418 can indicate a date and time when the raw data was captured. A zone zone 2420 that includes an indication of a zone with which the test point and related specific raw data are associated. A 2422 retest column can provide an indication of whether the raw data is from a test point retest. A product identification column 2424 can provide an identifier that identifies a piece of equipment or work surface with which specific raw data is associated. A plant identification column 2426 can provide a plant identifier that identifies a plant or other production or manufacturing facility in which the test point is located. A 2428 note column includes notes related to the respective test point. An alert column 2430 includes an indication of an alert threshold at which an alert result occurs. A fault column 2432 includes an indication of a fault threshold at which a fault or fault result occurs. A 2434 gross RIU column includes a gross RIU indication for the respective test point.
[0230] Other raw data can be reported based on user selection from tabs 2406, for example, raw pH data, raw temperature data, raw conductivity data, or raw parts per million (PPM) data.
[0231] Vertical and horizontal scroll bars 2436a, 2436b allow the user to scroll through the table or graph of raw test data 2404.
[0232] The raw data screen 2402 can optionally include a filter menu 2438 that provides a number of selectable options per user to filter the data presented in the raw data table or graph 2404. For example, the user can select to view all test points as illustrated. Alternatively, the user can filter by sampling plans, for example, by location, equipment, zone and / or date.
[0233] Figure 25 shows a 2502 test point configuration screen for a user interface according to an illustrated modality, which can be presented on a display through a computer system processor, communicatively coupled to an instrument. portable monitoring systems like those described above. The 2502 test point configuration screen has a number of constructions or elements (for example, user-selectable icons, menus, indicators, scrollbars and controls) that are identical or similar to those on the 2302 instrument panel screen (figure 23) or 2402 raw data screen (figure 24). Similar or identical constructions or elements are identified using the same reference numbers as set out above, and discussion of those elements is not repeated in the interest of brevity. Only significant differences are discussed below.
[0234] The 2502 test point configuration screen includes a 2504 test point configuration table or graph to display various test points and associated information, allowing the user to configure or establish test points. The 2502 test point configuration screen also includes a number of user selectable test point configuration tabs 2506-2506f (six shown, collectively 2506), which a user can select to determine which type of test point is being configured and therefore what type of test point-related information is displayed on test point configuration screen 2502. For example, test point configuration screen 2502 may include an ATP test point configuration tab 2506a, tab pH test point configuration tab 2506b, temperature test point configuration tab 2506c, conductivity test point configuration tab 2506d, PPM test point configuration tab 2506e and standards test point configuration of PPM 2506f. a currently selected test point configuration tab 2406a (for example, ATP test points) can be visually indicated or emphasized, for example, through highlighting or a color change.
[0235] The 2504 test point configuration table or graph can, for example, be presented in rows or columns. For example, each row 2508-2508n (only two evoked) corresponds to a respective test point. The columns can include some of the columns described above with reference to figure 24. For example, a test point number column 2510 includes a test point number that identifies the test point. A 2512 test point name column can include a human recognizable test point name that identifies a respective test point. A 2514 sampling plan column can identify a portion of a sampling plan to which the respective test point is associated. This may include a 2515 user selectable expand / collapse icon (only one evoked) whose selection articulates between expanding and folding the respective cell and the sampling plan information contained therein. A product identification column 2524 includes a product identifier that identifies a piece of equipment or work surface with which the respective test point is associated. A plant identification column 2526 includes a plant identifier that identifies a plant or other production or manufacturing facility in which the respective test point is located. A 2428 note column includes notes related to the respective test point. An alert column 2530 includes an indication of an alert threshold at which an alert result occurs for the respective test point. A 2532 fault column includes an indication of a fault threshold at which a fault or fault result occurs for the respective test point.
[0236] Vertical and horizontal scroll bars 2536a, 2536b allow the user to scroll through the 2504 test point configuration table or graph.
[0237] In addition to a 2438 filter menu, test point configuration screen 2502 can include a number of user selectable action icons 2540a-2540d (collectively 2540). For example, selecting a new test point icon 2540a creates a new test point entry in the 2504 test point configuration table or graph, and in any associated database or other data structure. Selecting a test point edit icon 2540b allows the user to edit information about a test point entry in the 2504 test point configuration table or graph, and in any associated database or other data structure. Selecting a test point delete icon 2540c deletes a test point entry from the 2504 test point configuration table or graph, and in any associated database or other data structure. Selecting a new 2540d sampling plan icon creates a sampling plan entry in the 2504 test point configuration table or graph, and in any associated database or other data structure.
[0238] Figure 26 shows a new 2602 test point configuration screen for a user interface according to an illustrated modality, which can be presented on a display through a computer system processor, communicatively coupled to a portable monitoring instrument such as those described above. The new test point configuration screen 2602 has a number of constructs or elements (for example, user selectable icons, menus, indicators, scroll bars and controls) that are identical or similar to those on the 2302 instrument board screen ( figure 23) or test point configuration screen 2502 (figure 25). Similar or identical constructions or elements are identified using the same reference numbers as explained above, and discussion of those elements is not repeated in the interest of brevity. Only significant differences are discussed below.
[0239] The new test point configuration screen 2602 can be displayed in response to the selection of the new test point icon 2540a (figure 25). In response, a new row 2508n + 1 is configured in the 2504 test point configuration table or graph, and in any associated database or other data structure. The user can then fill in information in the various columns 2510, 2512, 2514, 2524, 2526, 2528, 2530, 2532 in the new row 2508n + 1 that updates the information in any associated database or other data structure.
[0240] Figure 27 shows a new sampling plan configuration screen 2702 of a user interface according to an illustrated modality, which can be presented on a display through a computer system processor, communicatively coupled to a portable monitoring instrument such as those described above. The new sampling plan configuration screen 2702 has a number of constructions or elements (for example, user-selectable icons, menus, indicators, scroll bars and controls) that are identical or similar to those on the 2302 instrument board screen ( figure 23) or test point configuration screen 2502 (figure 25). Similar or identical constructions or elements are identified using the same reference numbers as set out above, and discussion of those elements is not repeated in the interest of brevity. Only significant differences are discussed below.
[0241] In response to the selection of the new sampling plan icon 2540d, a new sampling plan dialog box 2750 is displayed, allowing the user to specify a new sampling plan. The new 2750 sampling plan dialog box includes a number of fields. For example, a sampling plan name field 2752 allows the user to enter a name for the new sampling plan. The sampling plan name can be text and / or numeric, and it can be recognizable by human. The sampling plan name can be entered via screens on a keyboard or keyboard keys or virtual key block. The new sampling plan dialog box 2750 can include a description field 2754 that allows a user to enter a description of the new sampling plan. Again, the description can include alphanumeric characters and can be understandable by humans. The new sampling plan dialog box 2750 can have a 2756 test point entry field that allows the user to specify test points for association with the sampling plan. Test points can be identified by test point number and / or test point name. The test point number or names can be entered manually, by typing or typing, or they can be dragged and dropped from a table or graph. The new sampling plan dialog box 2750 can include a selection field, icon, or pull down menu 2758 to select test points, for example, allowing selection of all defined test points, or all identified test points in a table or graph. The new sampling plan dialog box 2750 includes alert threshold field 2760 and failure threshold field 2762, allowing the user to specify threshold values that produce alert and fault results, respectively. The new sampling plan dialog box 2750 can also include a note field 2764, which allows the user to enter notes related to the sampling plan. Notes can be alphanumeric characters and must be understandable by humans.
[0242] The new 2750 sampling plan dialog includes a number of selectable action icons per user. For example, the user selection of a save icon 2766 causes the new sampling plan to be saved together with the information specified in the various fields of the new sample plan dialog box 2750. The user selection of an icon cancel 2768 cancels the creation of the new sampling plan without saving changes to any database or other data structure. Selecting a 2770 delete icon per user deletes an existing sampling plan from a database or other data structure.
[0243] Figure 28A shows an upper portion and figure 28B shows a lower portion of a HACCP 2802 report screen of a user interface according to an illustrated modality, which can be presented on a display via a processor. a computer system, communicatively coupled to a portable monitoring instrument such as those described above. The HACCP 2802 reporting screen has a number of constructs or elements (for example, user-selectable icons, menus, indicators, scrollbars and controls) that are identical or similar to those on the 2302 dashboard screen (figure 23) . Similar or identical constructions or elements are identified using the same reference numbers as set out above, and discussion of those elements is not repeated in the interest of brevity. Only significant differences are discussed below.
[0244] In place of the various charts or tables on the 2302 instrument panel screen (figure 23), the HACCP 2802 report screen included a HACCP 2804 compliance report. The HACCP 2804 compliance report may include some fixed portions , such as titles, headings, dates, lines, margins, etc., as well as some fillable portions per user and other portions that can be automatically populated with information, for example, based on user selections.
[0245] For example, the HACCP 2804 compliance report can include a field created by 2806 that allows the user to enter an identifier that specifies the person or entity that creates the compliance report. This can be a human recognizable name or an identity code. The identifier can be entered via a keyboard or virtual keyboard. A 2808 logo field can allow a user to upload a logo, for example, a company logo, to customize the report.
[0246] A description field 2810 allows the user to enter a textual description. This may allow free-form text input including alphanumeric characters. The description can be entered via a keyboard or virtual keyboard.
[0247] A 2812 chart field allows the user to include one or more charts. Charts can include axes (for example, vertical axis 2814 and horizontal axis 2816). Selecting a 2818 chart type pull down menu icon expands a chart type pull down menu that allows the user to specify a chart type from a number of defined chart types. This determines the type of data to be plotted. Selecting a 2820 chart date range pull down menu icon expands a date range pull down menu that allows the user to specify a date range for data that will populate the chart. The chart can be automatically populated based on the type of chart selected by user and date range using previously collected information or data. In the absence of user selection of a chart type, the chart can be omitted from the 2804 compliance report.
[0248] A table field 2822 allows the user to include one or more tables. Tables can include one or more rows and one or more columns. A pull-down menu of table type 2824 allows the user to specify a table type from a number of defined table types. This determines the type of data to be included in the table. A 2826 table date range pull down menu allows the user to specify a date range for data that will populate the table. The table can be automatically populated based on the type of table selected by the user and the date range of the table using previously collected information or data. In the absence of user selection of a table type, the table can be omitted from the 2804 compliance report.
[0249] A 2828 calibration log field allows the user to include one or more calibration log tables. The calibration log tables can include one or more rows of calibration dates, that is, dates on which a portable monitoring instrument has been calibrated. A 2830 date range pull down menu allows the user to specify a date range for data that will populate the calibration log table. The table can be automatically populated based on the selected date range using previously collected information or data. In the absence of user selection for a date range, the calibration log table can be omitted from compliance report 2804.
[0250] The HACCP 2804 compliance report can include a summary of statistics, represented in the same or similar way as on the 2302 dashboard screen. Thus, the summary of statistics can include a test report section 2832 , an alert results report section 2834, a failure results report section 2836, and a calibration report section 2838. A HACCP 2830 report scroll bar allows the user to scroll through the HACCP 2804 report.
[0251] The HACCP 2802 report screen can also include user-selectable action icons 2840a-2840d (four shown, collectively 2840). For example, selecting an add chart 2840a icon creates or generates a new chart or new chart field in the HACCP 2804 report. Selecting an add table 2840b icon creates or generates a new table or new table field in the report. HACCP 2804. Selecting an add 2840c calibration log icon creates or generates a new calibration log table or new calibration log table field in the HACCP 2804 report. Selecting an add statistics icon Summary Table 2840d creates or generates new summary statistical report sections in the HACCP 2804 report.
[0252] Figure 28C shows the upper portion of the HACCP 2802 report screen with an expanded 2842 graphical pull down menu, according to an illustrated modality. The 2842 chart type pull down menu includes a number of user selectable icons, which identify specific chart types from which the user can select. Graph type icons may, for example, include number of used cotton swabs 2842a, retests performed by test point 2842b, retests performed by date range 2842c, calibration / verification records 2842d, and compliance / partial compliance records / non-conformity (C / PC / NC) 2842e. The user's selection of a chart type, and optionally, a date range, can cause automatic occupation of a chart with the appropriate data or information.
[0253] Figure 28D shows the upper portion of the HACCP 2802 report screen with an expanded date range selection element 2844, according to an illustrated modality. The date range pull down menu 2844 includes a start date calendar 2844a to select a start date and an end date calendar 2844b to select an end date for the range. The 2844 date range pull down menu can include a check box for all 2844c dates, the selection of which selects all available dates for the date range.
[0254] Figure 29 shows a high level method 2900 of operating a portable monitoring instrument to collect data collected, for example, using swabs, according to an illustrated modality. In 2902, the 2900 method begins. This can, for example, be in response to TURN ON or power on the portable monitoring instrument. In 2904, a sensor detects the insertion of a cotton swab into the portable monitoring instrument. The sensor may, for example, take the form of an optical transmitter / receiver pair, positioned to pass light through a swab receiving passage. Alternatively, the sensor may be in the form of a contact switch, or any other device capable of detecting a swab or a cover position that selectively controls access to the swab receiving passage.
[0255] In 2906, a reader reads an identifier from the swab. The reader may be in the form of an imager that captures an image of a portion of the cassette. The reader may be in the form of a scanner that scans a portion of the swab, for example, as the swab moves through a sensor. the reader can take the form of an optical reading, including at least one photodetector, for example, a photodiode or a set of devices coupled to the load. where an optical reader is employed, it may include a dedicated light source, for example, an incandescent light, fluorescent light or light emitting diode (s). The reader may alternatively or additionally take the form of a magnetic reader, for example, a magnetic stripe reader that can read information encoded on a magnetic stripe carried by the swab. Alternatively or additionally, the reader may take the form of an interrogator or radio frequency identification (RFID) reader, which wirelessly interrogates an RFID tag or transponder carried by the swab. Other forms of readers can be employed.
[0256] In 2908, a controller, for example, a microprocessor, determines whether the identifier read from the swab is a valid identifier. The controller can compare the read identifier with a stored identifier. If the identifier is not valid, the controller provides notification of invalidity in 2910. The notification can be provided through a user interface of the portable monitoring instrument. In 2912, a light source illuminates a sample contained in a portion (for example, tip) of the swab. In 2914, one or more sensors detect sample illumination results. For example, one or more optical sensors can detect an optical response of the sample to illumination. In 2916, a controller, for example, a microprocessor, stores raw result data with date and time indication to a computer-readable medium or non-transitory processor. This can be stored in a database or other data structure (eg, record) in a computer-readable medium or non-transitory processor. In 2918, the 2900 method ends. The method can end until it is instituted or called again. Alternatively, the 2900 method can continue to run as a background process, until a new swab is detected.
[0257] Figure 30 shows a high level 3000 method of operating a portable monitoring instrument to collect data collected, for example, through transducers or external probes, according to an illustrated modality. In 3002, the 3000 method begins. This can, for example, be in response to TURN ON or power on the portable monitoring instrument. This can alternatively be in response to the selection of one or more user input elements (for example, user selectable icons, keys, switches). In 3004, a controller, for example, a microprocessor, tests one or more ports for coupled transducers. The controller can test a circuit that detects the presence of a coupled transducer. Presence can, for example, be determined by detecting physical presences, or it can be determined by detecting an electrical characteristic such as impedance. The physical presence can be detected through an optical transmitter-receiver pair, physical contact switch or other element.
[0258] In 3006, the controller determines whether a transducer or probe is attached to any of the ports. In 3008, the controller samples ports to which a transducer is attached. Sampling collects data from gross results measured or otherwise felt by the respective transducers. The raw result data can be in digital form. Alternatively, a digital to analog converter can be used to convert raw analog output data into a digital form. In 3010, the controller stores raw result data (for example, pH, temperature, conductivity, ppm) with date and time indication for a computer-readable medium or a non-transitory processor. This or another data structure (for example, record) in a computer-readable medium or non-transitory processor. In 3012, the 3000 method ends. The method can end until it is instituted or called again. Alternatively, the 3000 method can continue to run as a background process.
[0259] Figure 31 shows a main method 3100 of operating a portable monitoring instrument to collect data collected, for example, using swabs, according to an illustrated modality.
[0260] The main method 3100 starts at 3102. This can, for example, be in response to the ON or hand-on of the portable monitoring instrument. After starting, the main method performs a series of initialization activities. For example, one or more processor (s) can be started in 3104. Also for example, the processor (s) can run a series of self tests in 3106. Problems or errors, if any, that are detected during self-tests can be recorded and / or reported. Depending on the severity of any problems or errors detected, the main method may continue, or end, by stopping the operation of the portable monitoring instrument. Various components can be initialized in 3108. These components can, for example, include various circuit panels, power sources, analog to digital converters (ADCs) and other components. As an additional example, several firmware modules can be initialized in 3110. This may include initializing one or more databases and / or graphics.
[0261] After initialization, main method 3100 enters a main control loop, as indicated in 3112 and by return derivation 3112a. the main control loop is where the portable monitoring instrument performs its main functions in collecting and analyzing data. The main control loop includes a number of task subloops that include the execution or performance of several tasks, each associated with a respective timing cycle in which the task subloop is triggered.
[0262] As illustrated, the primary control loop 3112, 3112a can include a first task subloop indicated at 3114 and 3116, a second task subloop indicated at 3118 and 3120, and a third task subloop indicated at 3122 and 3124. The first, second and third task subloops can, for example, have timing cycles that repeat every 1 ms, 32 ms and 512 ms, respectively.
[0263] During the first task subloop, the processor (s) and / or other components perform a first set of tasks. For example, the processor (s) and / or other components can perform tasks to take measurements or capture data and / or pre-process or process the data. This may include controlling lighting and / or controlling capture of electromagnetic energy returned from a sample or specimen. This can also include pre-processing or processing of measured or captured data, for example, normalizing or correlating these and / or formatting them. Also, for example, the processor (s) and / or other components can perform tasks related to calibration. This may, for example, include determining whether one or more sensors are within a sensor-calibrated tolerance, determining whether one or more light sources are within a source-calibrated tolerance, and calibrating against one or more sensors or light sources . As an additional example, the processor (s) and / or other components can perform tasks related to the load. Load tasks may include monitoring or determining an external source or type of external source that supplies power, if any at the given time. For example, electrical power can be supplied via a USB port (for example, 5V) or through a port for an input from an external power source. The external power source can, for example, be an adapter (for example, wall adapter) that receives common household current (for example, AC 120 V, 60 Hz) and lowers the voltage and rectifies the current (for example, 12VDC ). Charge tasks can additionally or alternatively include monitoring or determining a characteristic (eg charge level, voltage, number of recharge cycles, age) of an onboard power source. Charging tasks may include ensuring that an on-board power source is adequately charged via a charging circuit (for example, power converter and rectifier in switching mode). Some exemplary tasks suitable for performance as part of the first task subloop are illustrated and discussed below with reference to figure 32.
[0264] During the second task subloop, the processor (s) or other components can perform probe detection task. This can, for example, include checking a state or condition of one or more sensors. This may include additionally or alternatively verifying the authenticity of a specimen or sample probe, for example, by verifying sensory data indicative of the presence of a safety signal or safety chip, for example, radio frequency identification (RFID) or transponder of electronic article surveillance (EAS), carried by specimen probe or authenticated sample. As described here, sample or specimen probes can have unique traits or characteristics that improve the accuracy or reliability of measurements. In this way, the confirmation ensures that the results will be reliable.
[0265] During the third task subloop, the processor (s) or other components maintain a real-time clock. For example, the processor (s) or other components can determine a real world time based on a number of system clock or oscillator cycles that have occurred since a previous time. This does not require an especially high degree of precision of mode that can be performed at a relatively slow rate once every 512 ms.
[0266] Many of the tasks of the subloops are further described here, for example, with the methods illustrated in figures 32 and described in reference to them.
[0267] Also, as part of executing the primary control loop 3112, 3112a, the processor (s) or other components can perform various communications-related tasks. For example, the processor (s) or other components may receive and / or transmit information, data and / or instructions through one or more communication ports. This may include wired and / or wireless communications. Communications can employ any communications standards or protocols, for example, Universal serial Bus® (USB), FireWire®, Thunderbolt®, Ethernet®, IEEE 802.11 protocols and infrastructure.
[0268] Also, as part of executing the primary control loop 3112, 3112a, the processor (s) or other components can perform various user interface tasks. For example, the processor (s) or other components can receive user input and / or provide user output through various user interface devices (for example, touch sensitive display, trackpad, joystick, thumbstick, Keys speakers, LEDs, LCDs, displays, microphones). In particular, the processor (s) or other components may present information to the end user, for example, data, prompts, instructions, user-selectable input controls, etc. The processor (s) or other components can poll various user input devices to receive user selections, instructions and / or other information.
[0269] Figure 32 shows a first subloop method of task 3200 of operating a portable monitoring instrument to collect data collected, for example, using swabs, according to an illustrated modality. As noted above, the first 3200 task subloop can be run at a relatively high rate or frequency (for example, 1 ms). As such, tasks performed as part of the first 3200 task subloop have low latency and low agitation.
[0270] The first task subloop method 3200 starts at 3202. This can, for example, start in response to an interruption (for example, a high priority interruption) or in response to some other call, for example, a call from the main method 3100 (figure 31).
[0271] In 3204, the processor (s) or other components perform a high voltage control loop method to provide high voltage to other components, for example, to provide a high voltage to a multi-photon counter. pixels (MPPC) in the defined voltage range.
[0272] In 3206, the processor (s) or other components perform an ATP temperature control loop method. This may, for example, include adjusting a temperature at least close to the sample or specimen using active cooling structures.
[0273] In 3208, the processor (s) or other components perform an ATP measurement service method. This may, for example, include illuminating a sample or specimen carried by a swab or probe, and detecting or measuring illumination returned from the sample or specimen.
[0274] In 3210, the processor (s) or other components perform a touch screen feel method. This may, for example, include probing several touch sensitive sensors (for example, capacitive, resistive, inductive, infrared) that are part of a touch sensitive display device. This may also include identifying an input or command associated with the activated sensors.
[0275] In 3212, the processor (s) or other components perform a beeper service routine. For example, the processor or other components help to produce any tones, beeps or other sounds that are indicated by the conditions. For example, the processor (s) or other components can cause a speaker or bell to produce an alert.
[0276] In 3214, the processor (s) or other components return from the interruption that triggered the execution of the first task subloop method 3200.
[0277] Figure 33 shows a 3300 high voltage controller to control a high voltage supply for components of a portable monitoring instrument, according to an illustrated experiment. The 3300 high voltage controller can run in response to an interrupt called from the first task subloop method 3200 (figure 32) or it can run in the background.
[0278] The high voltage controller 330 includes a variable high voltage supply 3402, which is responsive to a control voltage 3304 to provide high voltage 3306 for one or more components, for example, an MPPC 3308. The control voltage 3304 is generated by a 3310 high voltage proportional integral derivative (PID) controller, such as a 3312 variable pulse width modulated (PWM) trigger signal, which can be filtered by a 3314 low-pass filter. high voltage 3310 receives two inputs 3316, 3318. A first input 3316 is indicative of a high voltage setpoint 3320 provided through a voltage source. The second input 3318 is indicative of a high voltage value being provided by the variable high voltage source 3402. Notably, the second input 33118 does not itself need to be a high voltage, but instead simply represents the magnitude of the high voltage 3306 In particular, the value can be felt or generated through a precision resistor divider network 3322, and supplied to the 3310 high voltage PID controller via an analog to digital converter 3324.
[0279] Figure 34 shows a temperature controller 3400 for controlling a temperature of a sensor, for example, an MPPC of a portable monitoring instrument, according to an illustrated modality. The 3400 temperature controller can run in response to an interruption or call from the first 3200 task subloop method (figure 32) or it can run in the background.
[0280] The 3400 temperature controller includes a 3402 thermoelectric cooler (for example, Peltier effect cooler), which is responsive to a 3404 control signal, for example, a PWM control signal, to adjust a temperature (for example, remove heat) from a master, such as an MPPC 3406. The control signal 3304 is generated by a thermoelectric cooler driver 3408. The thermoelectric cooler driver 3408 is responsive to a variable PWM signal 3410 generated by a high voltage PID controller 3412 The high voltage PID controller 3412 receives two inputs 3414, 3416. A first input 341 is indicative of a temperature setpoint 3418. The second input 3318 is indicative of a temperature of, or a temperature at least close to, the MPPC 3406 as measured, detected or otherwise felt by a 3420 temperature sensor. The indicative temperature value can be supplied to the 3412 temperature PID controller via a convert r from analog to digital 3422.
[0281] Figure 35 shows a method of measuring ATP 3500 for use in operating a portable monitoring instrument to collect data from samples, for example, carried by swabs, according to an illustrated modality.
[0282] The ATP 3500 measurement method starts at 3502. This can, for example, start in response to an interruption or call, for example, a call from the first task subloop method 3200 (figure 32).
[0283] In 3504, a processor (s) or other component of the instrument detects a user input indicative of a selection to perform ATP measurements. The processor (s) or other component can, for example, detect, a user selection of a user selectable icon of measuring ATP displayed as part of a GUI. Alternatively, the processor (s) or other component may detect user selection from one or more keys, buttons or switches, or a spoken command.
[0284] In 3506, the processor (s) or other component prompt the user to insert a cotton swab and close a door that provides access to an instrument's darkroom. The processor (s) or other component can cause a prompt to be displayed through a GUI, for example, by displaying an appropriate message or dialog box. In addition, or alternatively, the processor (s) or other component may cause the prompt to be provided as an audible message through an instrument speaker.
[0285] In 3508, the processor (s) or other component determines whether the door to the darkroom door is open. The door not only selectively provides access to the interior of the darkroom, but it is also used to prevent or limit the entry of light into the darkroom from outside sources. This facilitates accurate readings.
[0286] If the processor (s) or other component determines that the port is felt or detected as being in an open state or condition, the processor (s) or other component will prompt the user to close the door at 3510, and return control to 3508. The processor (s) or other component may cause the prompt to be displayed through a GUI, for example, by displaying an appropriate message or box dialog. In addition or alternatively, the processor (s) or other component may cause the prompt to be provided as an audible message through an instrument speaker. This can essentially institute a blocking mechanism, the loop preventing the instrument from performing ATP measurements until the condition is tended, consequently ensuring the reliability of felt and / or recorded or reported data. Conversely, if the processor (s) or other component determines that the door is felt or detected as being in a closed state or condition; the control changes to 3512 without providing the prompt at 3510.
[0287] In 3512, the processor (s) or other component tries to validate a cotton swab that has been inserted. The processor (s) or other component determines whether the swab that was inserted is valid or authenticated. This may include reading one or more safety signs carried by the swab.
[0288] Safety signs can take a variety of forms. For example, safety signs may be one or more machine-readable, optically readable symbols printed on embossed on prints, embossed or otherwise inscribed or applied to a portion of the swab. Machine-readable symbols that are optically readable can be encoded or form part of one or more human-readable symbols. For example, a flat portion of a probe may carry a trademark or trade name, which is human-readable. A portion of the trademark or trade name encodes or constitutes the machine-readable, which may not be human-readable. In this way, forward and / or back edges of letters or other elements of the trade name or trademark as seen with respect to a straight scan line passing through them, may constitute a type of machine-readable symbol (for example, linear bar). Alternatively, a two-dimensional area or matrix code symbol can be employed. In some embodiments, the machine-readable symbol may not be visible to humans, for example, being optically detectable only in the ultraviolet or infrared portions of the electromagnetic spectrum.
[0289] Safety signs may have a non-optical shape. For example, safety signals may additionally or alternatively include one or more wireless transponders carried by the swab. Wireless transponders can take a variety of forms, for example, radio frequency identification (RFID) transponders that store or otherwise encode an ex-clusive identifier. If employed, RFID transponders are likely to be in the form of passive RFID transponders, not having a discrete power source (for example, chemical battery cells). The detection of RFID transponders typically includes reading the unique identifier from an RFID transponder in an interrogation field produced by a radio or interrogator, which may be part of the instrument. The unique identifier can be transmitted wirelessly or returned to the radio or interrogator in an encrypted form to further increase security.
[0290] Alternatively or in addition, the wireless transponder may take the form of an electronic surveillance article (EAS) transponder. EAS transponders typically do not store or encode unique identifiers. The detection of EAS transponders is typically a simple detection of the presence or absence of an EAS transponder in an interrogation field produced by a radio or interrogator.
[0291] If the processor (s) or other component cannot validate or authenticate the swab, the processor (s) or another component performs an error routine at 3514. If the swab is validated, the control it goes directly to 3516, without executing the error routine 3514. The performance of the error routine can include performing one or more actions. For example, the processor (s) or other component may record the attempt to use an invalid or authenticated swab in a record maintained on computer-readable media or a non-transitory processor. Also, for example, the processor (s) or other component may generate an alert. The generation of the alert may include providing the alert to an end user through the instrument's UI. For example, an appropriate visual alert message or dialog box can be displayed via an instrument display, an indicator (eg, red LED) can be illuminated, and / or an appropriate provided an appropriate audible alert message can be displayed. presented through a loudspeaker of the instrument. Additionally or alternatively, generating the alert may include having the alert provided to remote individuals or systems located remotely from the instrument. For example, the processor (s) or other component can cause an appropriate alert message to be transmitted wirelessly and / or wired from the instrument via a transmitter, port or radio.
[0292] In 3516, the processor (s) or other component performs the ATP measurement. For example, the processor (s) or other component can sample the sensor, adding beads during an integration period and subtracting dark beads from the sum (s).
[0293] In 3518, the processor (s) or other component prompt the end user to remove the swab and close the door to the darkroom. The processor (s) or other component can cause the prompt to be displayed through a GUI, for example, by displaying an appropriate message or dialog box. In addition, or alternatively, the processor (s) or other component may cause the prompt to be provided as an audible message through an instrument speaker. In 3520, the processor (s) or other component determines whether the swab has been removed and the door closed. The processor (s) or other component can consult one or more sensors, which detect: 1) if a swab is present, and 2) position or condition of a door. If the swab has not been removed or the door is not closed, the control returns to 3518, where the processor (s) or other component again prompt the end user to remove the swab and / or close the door.
[0294] After the swab has been removed and the door closed, the processor (s) or other component provides results. The processor (s) or other component can deliver the results to an end user through the UI devices or elements. For example, the processor (s) or other component can cause the results to be displayed through an instrument display. In addition, or alternatively, the processor (s) or other component can cause the results to be presented in aural way, through a loudspeaker of the instrument. Additionally or alternatively, the processor (s) or other component can provide the results to remote individuals or systems, located remotely from the instrument. For example, the processor (s) or other component may cause an appropriate results message to be transmitted wirelessly and / or wired from the instrument through a transmitter, port or radio. Results can be presented in any of a variety of formats, for example, in zone units.
[0295] Figure 36 shows a dark count calibration method 3600 for use in the operation of a portable monitoring instrument to collect data from samples, for example, carried by swabs, according to an illustrated modality. Many sensors, for example, MPPC sensors produce thermally generated background counts, which occur even in the dark. These can be termed "dark counts." Calibration for such dark counts improves the accuracy of results during testing or further analysis of a sample or specimen.
[0296] The dark count calibration method 3600 starts at 3602. This can, for example, start in response to an interruption or call, for example, a call from the first task subloop method 3200 (figure 32).
[0297] In 3604, the processor (s) or other component of the instrument determines whether a current dark count calibration is valid. For example, the processor (s) or other component can determine whether a time period has been exceeded. For example, the processor (s) or other component can determine whether a time period since a more recent calibration has exceeded a defined time limit. The defined time limit can be empirically adjusted based on observations of how long it typically takes for an instrument to go out of calibration. The defined time limit can be adjusted to include an adequate margin of error, for example, based on statistical evaluation of the empirical results. In addition or alternatively, the processor (s) or other component can determine whether an instrument temperature, a portion of the instrument and / or in an environment at least close to the instrument is outside a defined temperature limit range. The defined temperature limit range can be empirically adjusted based on observations of the temperature variation effect of the instrument or portions of it (for example, MCCP, light sources such as LEDs that are temperature sensitive). The defined temperature limit range can be adjusted to include an adequate margin of error, for example, based on statistical evaluation of the empirical results.
[0298] If the processor (s) or other component determines that the current dark count calibration is valid, the control returns to 3604, a wait loop is implemented. If the processor (s) or other component determines that the current dark count calibration is not valid, the control changes to 3606.
[0299] In 3604, the processor (s) or other component of the instrument determines whether the door to the darkroom door is open. The door not only selectively provides access to the interior of the darkroom, but is also used to prevent or limit the entry of light into the darkroom from outside sources. This facilitates accurate readings. The processor (s) or other component may check a state or condition of a positioned sensor or otherwise responsive to a position, condition or state of the door.
[0300] If the processor (s) or other component determines that the door is felt or detected as being in an open state or condition, the processor (s) or other component prompt the user to close the door in 3608, and returns control to 3606. The processor (s) or other component can cause the prompt to be displayed through a GUI, for example, by displaying an appropriate dialog or message. In addition or alternatively, the processor (s) or other component may cause the prompt to be provided as an audible message through an instrument speaker. This can essentially institute a blocking mechanism, the loop preventing the instrument from performing the dark count validation until the condition is met, consequently ensuring the reliability of felt and / or recorded or reported data. Conversely, if the processor (s) or other component determines that the door is felt or detected as being in a closed state or condition, the control changes to 3610 without providing the prompt in 3608.
[0301] In 3614 the processor (s) or other component of the instrument determines whether the darkroom is empty. The presence of a cotton swab and / or probe will adversely affect the ability to perform accurate calibration. The processor (s) or other component can check a state or condition of a positioned sensor or otherwise responsive to the presence or absence of a swab or probe.
[0302] If the processor (s) or other component determines that the darkroom is not empty, the processor (s) or other component prompt the user to empty the darkroom at 3612, and returns control to 3606. The processor (s) or other component can cause the prompt to be displayed through a GUI, for example, by displaying an appropriate dialog or message. In addition or alternatively, the processor (s) or other component may cause the prompt to be provided as an audible message through an instrument speaker. This can essentially institute a blocking mechanism, the loop preventing the instrument from performing the dark count calibration until the condition is met, consequently ensuring the reliability of felt and / or recorded or reported data. Conversely, if the processor (s) or other component determines in 3610 that the darkroom is empty, the control changes to 3614 without providing the prompt in 3612.
[0303] In 3614, the processor (s) or other sample component (s) the sensor and determine (m) a darkroom calibration value, adding up the counts over a calibration period. Since the darkroom is empty, the counts represent measurements of background lighting in the darkroom, unrelated to any samples or specimens.
[0304] In 3616, the processor (s) or other component determines whether the determined darkroom calibration value is within defined limits or threshold of an initial darkroom calibration value. If the darkroom calibration value is within defined limits or threshold of the initial darkroom calibration value, in 3618 the processor (s) or other component accepts (that is, defines) the new value of darkroom calibration as the value for darkroom calibration in performing ATP measurements. Conversely, if the determined darkroom calibration value is not within defined limits or threshold of the initial, the processor (s) or other component performs an error routine at 3620.
[0305] Error routine 3620 may include one or more acts. for example, the processor (s) or other component may (s) reject (that is, not define or employ) the new darkroom calibration value. In addition, the processor (s) or other component may prompt the end user to check at least one that the darkroom is empty (for example, swab and / or probe removed) that the door stops. the darkroom is closed. The processor (s) or other component can cause the prompt to be displayed through a GUI, for example, by displaying an appropriate message or dialog. Additionally or alternatively, the processor (s) or other component may cause the prompt to be provided as an audible message through an instrument speaker.
[0306] The various modalities described above can be combined to provide additional modalities. All US patents, US patent application publications, US patent application, foreign patents, foreign patent application and non-patent publications mentioned in this specification and / or listed in the order data sheet, including, but not limited to US patent application serial number 12 / 135,934; filed on June 9, 2008; US patent application no. Serial 11 / 354,413, deposited on 02/14/06; US patent application no. Series 10 / 313,941, deposited on 5/12/02; and US patent application no. Series 60 / 338,844, deposited on 12/06/01 and incorporated here as a reference, in full. Aspects of the modalities can be modified, if necessary to employ concepts from the various patents, applications and publications to further provide additional modalities.
[0307] These and other changes can be made to the modalities in the light of the above detailed description. In general, in the following claims, the terms used should not be interpreted as limiting the claims to the specific modalities revealed in the specification and claims, but should be interpreted as including all possible modalities together with the total scope of equivalents to which such claims have right. Therefore, the claims are not limited by the disclosure.
[0308] US patent application no. 61 / 666,637, filed on June 29, 2012 and US patent application no. 13 / 645,183, deposited on October 4, 2012 are hereby incorporated by reference in their entirety.

权利要求:
Claims (34)
[0001]
1. Portable monitoring system CHARACTERIZED by the fact that it comprises: a housing sized to be manually retained by a human being, the housing having a passage sized to receive removably at least one sample holder, the passage including at least one opening through the less close to a portion of the passageway that provides access into the passageway from outside the housing; a darkroom having an inner surface that at least partially encloses an interior of the darkroom, at least a portion of the optically reflective and spherical inner surface with an associated focal point, the darkroom located at a distal portion of the passageway with respect to at least an opening, the passage oriented towards the darkroom to position a distal portion of the sample holder to pass through the focal point of the spherical and optically reflective portion of the inner surface when the sample holder is removably received in the passage; at least one photo-responsive sensor exposed to the interior of the darkroom; at least one processor communicatively coupled to at least one photo-responsive sensor; and at least one screen communicatively coupled to at least one processor.
[0002]
2. Portable monitoring system, according to claim 1, CHARACTERIZED by the fact that it also comprises at least one sample holder, in which the distal portion of the sample holder is transparent at least in some wavelengths of light and in use contains a liquid, and the passageway positions the distal portion of the sample holder with a portion of the liquid coinciding with the focal point of the spherical and optically reflective portion of the internal surface when the sample holder is removably received in the passage, and the transparent distal portion and the liquid form a cylindrical lens that has a coincident focus with at least one photo-responsive sensor.
[0003]
3. Portable monitoring system according to claim 2, CHARACTERIZED by the fact that the transparent distal portion of the sample holder is spaced from at least one photo-responsive sensor by a distance that at least approximately matches a focal length of the cylindrical lens formed by the transparent distal portion and the liquid retained therein.
[0004]
4. Portable monitoring system, according to claim 2, CHARACTERIZED by the fact that the liquid includes reagent and sample leached from a test swab received by the sample holder.
[0005]
5. Portable monitoring system, according to claim 1, CHARACTERIZED by the fact that at least one photo-responsive sensor is a multi-pixel photon counter in the form of a set of avalanche photodiodes.
[0006]
6. Portable monitoring system, according to claim 1, CHARACTERIZED by the fact that more than half of the inner surface of the darkroom is reflective and spherical.
[0007]
7. Portable monitoring system, according to claim 1, CHARACTERIZED by the fact that the darkroom comprises a first unitary portion and a second unitary portion, the second unitary portion physically coupled to the first unitary portion.
[0008]
8. Portable monitoring system, according to claim 1, CHARACTERIZED by the fact that the inner surface of the darkroom carries a reflective layer.
[0009]
9. Portable monitoring system, according to claim 1, CHARACTERIZED by the fact that the reflective layer is a metallic coating.
[0010]
10. Portable monitoring system, according to claim 9, CHARACTERIZED by the fact that the inner surface of the darkroom carries a protective oxide layer that overlaps and is spaced into the metallic layer.
[0011]
11. Portable monitoring system, according to claim 1, CHARACTERIZED by the fact that the camera includes first opening in which the passage is coupled to the camera, and a second nearby opening that at least one photo detector is optically coupled to the interior the camera.
[0012]
12. Portable monitoring system, according to claim 11, CHARACTERIZED by the fact that the second opening is substantially perpendicular to the first opening.
[0013]
13. Portable monitoring system, according to claim 1, CHARACTERIZED by the fact that it also comprises: a mechanical safety mechanism that includes an irregular surface that has a non-circular internal profile that is complementary to a non-circular external profile of a portion of the sample holder to be received in the passage.
[0014]
14. Portable monitoring system, according to claim 13, CHARACTERIZED by the fact that the mechanical safety mechanism is part of the passage or at least close to the opening of the passage.
[0015]
15. Portable monitoring system, according to claim 13, CHARACTERIZED by the fact that the internal non-circular profile is a D-shaped profile.
[0016]
16. Portable monitoring system, according to claim 1, CHARACTERIZED by the fact that each sample holder has an elongated rod having a flat portion, and in which the portable monitoring system further comprises: a machine-readable symbol reader positioned to read at least a portion of a machine-readable symbol on the flat portion of the elongated rod of the test swab when the sample holder is received at least partially in the passage, the machine-readable symbol reader communicatively coupled to at least one processor .
[0017]
17. Portable monitoring system according to claim 16, CHARACTERIZED by the fact that the machine-readable symbol is stamped on the elongated rod of the test swab and the machine-readable symbol reader includes at least one of a symbol engine machine-readable or a machine-readable symbol engine.
[0018]
18. Portable monitoring system, according to claim 16, CHARACTERIZED by the fact that at least one processor determines whether the machine-readable symbol reader reads at least one machine-readable symbol that encodes valid authentication information, in which at least at least one processor obtains test results through at least one photo-responsive sensor and where at least one processor provides test results only for sample holders that include a respective machine-readable symbol that encodes valid authentication information.
[0019]
19. Portable monitoring system, according to claim 1, CHARACTERIZED by the fact that at least one display is operable to present output indicative of a level of biological contamination present in a test specimen inserted in the sample holder.
[0020]
20. Portable monitoring system, according to claim 19, CHARACTERIZED by the fact that it also comprises a keyboard communicatively coupled to at least one processor.
[0021]
21. Portable monitoring system, according to claim 19, CHARACTERIZED by the fact that at least one processor determines the level of biological contamination responsive to at least one output from at least one photo-responsive sensor, in which at least one processor compares the level of biological contamination to at least a first value or a second value, and where at least part of the screen displays a first color responsive to at least one indication by at least one processor that the level of biological contamination is lower that the first value; wherein at least a portion of the screen displays a second color that responds to at least an indication from the at least one processor that the level of biological contamination is greater than the second value; and wherein at least a portion of the screen displays a third color that responds to at least an indication from at least one processor that the level of biological contamination is greater than or equal to the first value and less than or equal to the second value.
[0022]
22. Portable monitoring system, according to claim 1, CHARACTERIZED by the fact that it also comprises the sample holder in the form of a probe assembly sized for insertion in the passage and the darkroom, and which includes a passing fluid conduit through at least a first cylindrical portion and ending in an optically transparent chamber at the distal portion at a distal end of the first cylindrical portion, a portion of the fluid conduit sized to accept the passage of a test swab that includes at least one shaft and a cotton swab tip.
[0023]
23. Portable monitoring system, according to claim 22, CHARACTERIZED by the fact that the probe assembly carries at least one authentication element detectable by at least one scanning device, and in which the portable monitoring system further comprising: at least one scanning device including at least one of: an electronic scanning device, an optical scanning device, and an infrared scanning device, in which at least one component of the portable monitoring system authenticates the probe assembly based on the least in part in detecting at least one authentication element.
[0024]
24. Portable monitoring system according to claim 23, CHARACTERIZED by the fact that at least a portion of an exterior of the first cylindrical section includes a D-shaped portion comprising a flat portion and a radius portion, the at least an authentication element on the flat exterior portion of the first cylindrical section, the at least one authentication element selected from the group consisting of: a wireless transponder, a machine-readable symbol, an engraved trademark, an engraved trade name, a printed trademark and a printed trade name.
[0025]
25. Portable monitoring system, according to claim 1, CHARACTERIZED by the fact that it also comprises at least one communication interface communicatively coupled to at least one processor, the communication interface to accept the communicable coupling of at least one external sensor .
[0026]
26. Portable monitoring system according to claim 25, CHARACTERIZED by the fact that at least one external sensor includes at least one of: a pH sensor, a dissolved oxygen sensor, a conductivity sensor and a sensor temperature.
[0027]
27. Portable monitoring system, FEATURED by the fact that it comprises: an elongated probe assembly having a close end and a distal end and a conduit that extends between an opening at least close to the close end and a substantially transparent chamber portion at least near the distal end, the conduit is sized and sized to receive a cotton swab in it through the opening; and an instrument including a housing, a darkroom mount, a multi-pixel photon counter, and at least one processor, the darkroom mount, the multi-pixel photon counter sensor and at least one processor housed by the housing, the darkroom assembly having a passageway sized to removably receive the elongated probe assembly thereon through an entrance that provides access into the passage from the exterior of the housing and ending in a darkroom having a surface at least partially enclosing the interior of the darkroom, at least a portion of the optically reflective and spherical inner surface with an associated focal point, the passage having a longitudinal axis that intersects the focal point of the optically reflective and spherical portion of the surface inside the darkroom, the multi-pixel photon counter sensor exposed to the inside of the darkroom and protected Any ambient light, the at least one processor communicatively coupled to the multi-pixel photon counter sensor.
[0028]
28. Portable monitoring system according to claim 27, CHARACTERIZED by the fact that in use the chamber portion of the probe assembly contains a liquid and a substantially transparent wall of the probe assembly and the liquid focuses on bioluminescence from a sample in the probe mount on the multi-pixel photon counter sensor.
[0029]
29. Portable monitoring system according to claim 27, CHARACTERIZED by the fact that the probe assembly includes at least one reagent reservoir and a membrane that holds a reagent in the reagent reservoir until violated.
[0030]
30. Portable monitoring system, according to claim 27, CHARACTERIZED by the fact that the instrument includes at least one spring that proposes to mount the probe in a first direction towards the entrance of the passage, and the instrument includes a cover selectively movable between an open position that provides access to the passage through the entrance from the outside of the housing and a closed position that engages access to the passage from the outside of the housing, and in which in the closed position the cover causes the assembly of probe is induced away from the entrance of the passage towards the darkroom.
[0031]
31. Portable monitoring system, according to claim 27, CHARACTERIZED by the fact that the instrument also includes a conductively coupled heat exchanger to transfer heat away from the multi-pixel photon counter sensor.
[0032]
32. Portable monitoring system according to claim 27, CHARACTERIZED by the fact that at least a portion of the probe assembly has a defined non-circular profile and a defined length, and at least a portion of the darkroom assembly has a complementary non-circular profile sized and sized to receive the probe assembly portion.
[0033]
33. Portable monitoring system according to claim 27, CHARACTERIZED by the fact that at least a portion of the probe assembly has an authentication value and the instrument includes at least one transducer positioned to read the authentication value when the assembly probe is at least partially inserted into the passage through the inlet.
[0034]
34. Portable monitoring system according to claim 27, CHARACTERIZED by the fact that a portion close to the probe assembly is opaque.

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法律状态:
2018-12-04| B06F| Objections, documents and/or translations needed after an examination request according [chapter 6.6 patent gazette]|

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2019-11-19| B06U| Preliminary requirement: requests with searches performed by other patent offices: procedure suspended [chapter 6.21 patent gazette]|

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2021-03-16| B09A| Decision: intention to grant [chapter 9.1 patent gazette]|

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2021-04-13| B16A| Patent or certificate of addition of invention granted [chapter 16.1 patent gazette]|Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 05/03/2013, OBSERVADAS AS CONDICOES LEGAIS. |

优先权:

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申请号 | 申请日 | 专利标题

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US201261666637P| true| 2012-06-29|2012-06-29|

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US61/666,637|2012-06-29|

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US13/645,183|US9446406B2|2012-06-29|2012-10-04|Sample collection and bioluminescent analysis system|

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US13/645,183|2012-10-04|

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PCT/US2013/029105|WO2014003832A1|2012-06-29|2013-03-05|Sample collection and bioluminescent analysis system|

---