Method of pasteurizing the water supply of laboratory diagnostic instruments

Abstract

A method and system for operating a temperature-controlled water supply system is provided. A reservoir holds water while a recirculating loop includes a pump, a water heater, and a manifold to supply water to a plurality of stations via a plurality of electrically controllable valves. A processor controls the recirculating loop to perform an assaying procedure, whereby the water heater heats the water to a temperature between 30 and 35 degrees Celsius and recirculating water is discharged from the manifold to the plurality of stations in accordance with an assaying procedure. The processor further controls the recirculating loop to perform a maintenance procedure to kill bacteria, whereby the water heater raises the temperature of recirculating water above 50 degrees Celsius and holds the temperature for a predetermined amount of time and purges the water through the plurality of stations.

Description

METHOD OF PASTEURIZING THE WATER SUPPLY OF LABORATORY DIAGNOSTIC INSTRUMENTSCROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit of priority of U.S. Provisional Patent Application Serial No. 63 / 673.420, filed on July 19. 2024, which is incorporated herein by reference in its entirety.TECHNICAL FIELD

[0002] The present application relates generally to sanitizing water supply systems and, more particularly, to sanitizing temperature-controlled water supplies and related systems of laboratory' diagnostic instruments.BACKGROUND

[0003] Temperature-sensitive assays require the precise thermal management of all the fluidic vessels, sub-systems and tubing that interact with them during diagnostic testing. Thermal management of the instruments’ internal environment may be challenging, often requiring large convective heaters and complex control loops. One such system is commonly a water supply system that recirculates temperature-controlled water at one or more pressures for use throughout the instrument.

[0004] An exemplary water supply subsystem for an in-vitro diagnostics (IVD) system includes basic water storage and supply, water temperature regulation, water filtration and degassing, and dilution probe cleaning. During normal operation, assaying operations are performed and the nominal temperature for the water supply loop in an IVD system is around that of the nominal human body temperature. While thermal maintenance at this temperature is helpful for IVD operations, this temperature is also an ideal temperature for bacterial growth. Bacterial grow th in the fluidics of an IVD system is a problem for many reasons, usually requiring downtime to clean out from the system.

[0005] Water supplies of diagnostic instruments can succumb to bacterial growth due to several factors. Filling of water supplies can introduce bacteria and keeping the water at near body temperatures, necessary for the instrument’s functions, encourages bacterial growth. Additionally, when faulty parts are replaced without being sterilized, bacteria could beintroduced to the system. Without user intervention to add chemicals to carry out decontamination procedures, there is no cost effective and regularly scheduled decontamination procedure. Many affected customer sites were shown to have bacteria present in the instrument water supply, most commonly Ralstonia picketti. In addition to bacteria clogging filters with their biofilm and discoloring parts, carry over issues appear when the microbiological quality’ of instrument water is poor.

[0006] The most common yvay to address bacteria in the water supply system is through chemical treatment. This can lead to additional problems such as chemical contamination, which requires a substantial flushing of the system to dilute and purge chemicals.SUMMARY

[0007] In some embodiments, a diagnostic device includes a system that uses existing temperature-controlling elements in a water system to pasteurize the water system during a maintenance operation.

[0008] According to one aspect of some exemplary embodiments, a water supply system, includes a reservoir configured to hold water and a recirculating loop configured to recirculate water to and from the reservoir that further includes a pump, a water heater, and a manifold configured to supply water to a plurality of stations via a plurality of electrically controllable valves. A processor is configured to operate the recirculating loop under software control to perform an assaying procedure during normal operation, whereby the water heater heats the water to a temperature between 30 and 35 degrees Celsius and recirculating water is discharged from the manifold to the plurality of stations in accordance with an assaying procedure. The processor is further configured to operate the loop to perform a maintenance procedure to kill bacteria, whereby the water heater raises the temperature of recirculating yvater above 50 degrees Celsius, holds the temperature for a predetermined amount of time, and the plurality of electrically controllable valves purge the water through the plurality of stations.

[0009] In some embodiments, the yvater heater comprises a first PTC heater yvith a first threshold of 30-35 degrees Celsius and a second PTC heater yvith a second threshold above 50 degrees Celsius. In some embodiments, the water heater comprises a resistive heating element controlled by a PID controller. In some embodiments, the processor is further configured to refill the reservoir with fresh yvater that is at or below 30-35 degrees Celsiusafter the maintenance procedure. In some embodiments, the processor is further configured to discharge the water above 50 degrees Celsius individually to each of the plurality’ of stations such that bacteria is killed in lines between each station and the manifold. In some embodiments, the processor is further configured to discharge a portion of the water prior to the water heater raising the temperature of recirculating water above 50 degrees Celsius such that a time needed to heat the water is reduced.

[0010] According to one aspect of some exemplary' embodiments, a method of operating a water supply system, includes filling a reservoir with water and providing a recirculating loop configured to recirculate water to and from the reservoir. The loop includes a pump, a water heater, and a manifold configured to supply water to a plurality of stations via a plurality of electrically’ controllable valves. The method further includes operating the recirculating loop under software control to perform an assaying procedure during normal operation, whereby the water heater heats the water to a temperature between 30 and 35 degrees Celsius and recirculating water is discharged from the manifold to the plurality’ of stations in accordance with an assaying procedure. The method further includes operating the recirculating loop under software control to perform a maintenance procedure to kill bacteria, whereby the water heater raises the temperature of recirculating water above 50 degrees Celsius, holds the temperature for a predetermined amount of time, and the plurality of electrically controllable valves purge the water through the plurality of stations.

[0011] In some embodiments, the water heater comprises a first PTC heater with a first threshold of 30-35 degrees Celsius and a second PTC heater with a second threshold above 50 degrees Celsius. In some embodiments, the water heater comprises a resistive heating element controlled by a PID controller. In some embodiments, the step of operating the recirculating loop further includes refilling the reservoir with fresh water that is at or below 30-35 degrees Celsius after the maintenance procedure. In some embodiments, the step of operating the recirculating loop further includes discharging the water above 50 degrees Celsius individually to each of the plurality of stations such that bacteria is killed in lines between each station and the manifold. In some embodiments, the step of operating the recirculating loop further includes discharging a portion of the water prior to the water heater raising the temperature of recirculating water above 50 degrees Celsius such that a time needed to heat the water is reduced.

[0012] According to one aspect of some exemplary embodiments, a method of operating the recirculating loop water system under software control includes a step of heating recirculating water to a first temperature between 30 and 35 degrees Celsius, recirculating the water to a manifold, and selectively discharging the water to a plurality of stations, each having a drain, during a normal operation. It further includes a step of killing bacteria byheating the recirculating water to a second temperature of the recirculating water above 50 degrees Celsius and holding the temperature for a predetermined amount of time during a maintenance procedure and purging the water through the plurality of stations via one or more valves.

[0013] In some embodiments, the step of heating the recirculating water to the first temperature comprises heating water with a first PTC heater with a first threshold of 30-35 degrees Celsius and the step of heating the recirculating water to the second temperature comprises heating water with a second PTC heater with a second threshold above 50 degrees Celsius. In some embodiments, the steps of heating the recirculating water to the first temperature and to the second temperature comprises heating water with a resistive heating element controlled by a PID controller. In some embodiments, the method further includes a step of refilling the reservoir with fresh water that is at or below 30-35 degrees Celsius after the maintenance procedure. In some embodiments, the step of purging the water includes discharging the water above 50 degrees Celsius individually to each of the plurality of stations such that bacteria is killed in lines between each station and the manifold. In some embodiments, the method further comprises a step of discharging, prior to the step of heating the recirculating water to a second temperature, a portion of the recirculating water such that a time needed to heat the water is reduced.BRIEF DESCRIPTION OF THE DRAWINGS

[0014] The foregoing and other aspects of the disclosed embodiments or systems and methods are best understood from the following detailed description when read in connection with the accompanying drawings. For the purpose of illustrating the disclosed technology, there is shown in the drawings embodiments that are presently preferred, it being understood, however, that the technology is not limited to the specific instrumentalities disclosed. Included in the drawings are the following Figures:

[0015] FIG. 1 is a system diagram of an exemplary water supply system that may be used in conjunction with disclosed embodiments;

[0016] FIG. 2 is a perspective view of an exemplary water supply system that may be used in conjunction with disclosed embodiments;

[0017] FIG. 3 is a system diagram of an exemplary water heater that may be used in conjunction with disclosed embodiments;

[0018] FIG. 3A is a system diagram of an exemplary water heater that may be used in conjunction with disclosed embodiments;

[0019] FIG. 4 is a flowchart of the operation of an exemplary water supply system that may be used in conjunction with disclosed embodiments;

[0020] FIG. 5 is a depiction of exemplary' test results using an exemplary maintenance procedure in accordance with disclosed embodiments;

[0021] FIG. 6 is a block diagram of an exemplary' IVD device that may be used in conjunction with disclosed embodiments; and

[0022] FIG. 7 is a system diagram of an exemplary IVD device that may be used in conjunction with disclosed embodiments.DETAILED DESCRIPTION OF EXEMPLARY EMBODIMENTS

[0023] While the concepts disclosed herein will be described with respect to an IVD system, the sanitation and maintenance processes can also be applied to other water supplies that include a processor-controlled heating system and a recirculation system.

[0024] Since many diagnostic instruments require w ater to be supplied at near human body temperature, they incorporate heaters to warm the supply water. This system uses the existing heater hardware to elevate the temperature of the water supply to invoke thermal death of microorganisms, thereby pasteurizing the water supply' and all components that are wetted. Research has indicated that temperatures in the 55-60°C range for a duration of 1 hour is effective at killing and minimizing the colony formation counts of bacteria typically found in water supplies.

[0025] Diagnostic instruments are typically decontaminated with chemicals only once a year or when bacteria overgrowth is detected. This new method uses existing heaters to raise the water temperature above its typical setting of 34°C. By increasing the temperature to 55- 60°C for 1 hour, the entire water supply can be pasteurized during the weekly maintenance routine. This system therefore incurs no additional costs or requires chemicals or sendee interv ention.

[0026] In a laboratory system, such as an IVD system, the water supply system must generally deliver water in accordance with a predefined specification. Exemplary' specifications dictate upper limits for ionic impurities (measured by resistivity), microbiological impurities (such as a maximum heterotrophic plate count), organic impurities (measured in ppb), particulate content (mitigated by7a defined filtration standard to create a maximum particulate size), dissolved gas. Exemplary' specifications also set required pressure and temperature ranges and minimum available flow rates for nominal operation.

[0027] FIG. 1 explains an exemplary water supply system 100 that can be designed to meet the standards required for a laboratory IVD system. A water source, such as a municipal water supply 102, supplies water to system 100. This source water can be filtered by filter 104 to reduce particulate and chemical impurities. Any suitable standard filtration method can be used. The flow of water from source 102 can be controlled by inlet valve 106. This can be a manual valve operated on demand by a person or a pneumatic / electromechanical valve that can be controlled by a processor, or a float valve. The source flow temperature can be monitored by temperature 108. This flow terminates in tank 110, which acts as a reservoir for the remaining system, allowing only intermittent use of source 102 when the level in tank 1 10 is lower than some threshold.

[0028] Water stored in tank 110 can be supplied to the rest of the system at a given pressure by using a low-pressure pump 114. The output pressure of this pump can be regulated or monitored. The output of pump 1 14 passes through a filter to remove particulate and chemical buildup to maintain the water supply within the defined specification. This filter should be replaced at regular service intervals, such as once or twice a year. The water then passes through heater 120. Heater 120 is used to maintain the water at a set temperature. In some embodiments, this can be operated under processor control, allowing the temperature to be set by software. In some embodiments, the output of heater 120 is directly measured for temperature or flow.

[0029] The heated water from heater 120 flows to low pressure manifold 130. Manifold 130 allows distribution of the water to different parts of the IVD system, such as wash stations, pipettes, assay stations, etc. Low pressure water is best suited for rinsing wash basins and drains and the outside of pipettes, and supplying water to be used in assays, such as dilution water for diluting reagents and samples under test, during normal operation. Each station or tool (low pressure stations 134) that will use the water from manifold 130 receives water from a processor-controlled valve 132. This allows a processor to supply water to individual stations 132 under software control. Each valve is an electrically controlled valve that receives a signal from a processor / circuit to open or close the valve. Power can come from electrical, pneumatic, or similar sources. Once the water has been dispensed at the station, it is evacuated from the system via drain line 136 that is shared by the stations.

[0030] Low-pressure manifold 130 has an outlet side that feeds into high-pressure pump 138. High-pressure pump 138 increases the pressure from the low-pressure manifold to supply high-pressure water to high-pressure manifold 140. Like low-pressure manifold 130, high-pressure manifold 140 acts as a distribution manifold to supply high-pressure water to various stations in the IVD device. Exemplary high-pressure stations 144 include sample and reagent pipettes. High pressure water is well suited for rinsing the inside of pipettes. The high pressure water can be ejected through the pipette at high velocity to rinse the inner surface efficiently. Water can be supplied from high-pressure manifold 140 to these high-pressure stations 144 via high-pressure supply valves 144. These supply valves, like low-pressure supply valves 132 can be processed or controlled allowing their selective delivery of high- pressure water under software control. Water used by the high-pressure stations is drained from the system via drain line 136. Water can be drained into a municipal plumbing system or treated before leaving the laboratory.

[0031] Outlet water from low-pressure manifold 130 and high-pressure manifold 140 can be returned to tank 110. This forms a water circulation loop, loop 150. Because circulation loop 150 includes one or more pumps (low-pressure pump 114 and high-pressure pump 138) and heater 120, it creates a temperature-controlled recirculation system for w ater at a set temperature. Heater 120 can heat up all of the reservoir water in tank 110, such that tank 110 acts as a heat reserv oir helping maintain the temperature of the water. If tubing uses a relatively insulated material, such as silicone or poly tubing, the amount of energy required to maintain the temperature of recirculation loop 150 can be minimal. Thus, loop 150 allowsan efficient recirculating temperature-controlled water supply to deliver water on demand via manifolds 130 and 140 and the relevant supply valves 132 and 142.

[0032] The return portions of loop 150 include a flow restrictor 148 that allows the pressure from high-pressure manifold 140 to be restricted such that it does not create a backflow through low-pressure manifold 130. allowing water to recirculate through the manifolds back to tank 110. An in-line temperature sensor 152 can provide processor feedback on the current temperature of the recirculating loop. This can be used by a temperature control scheme to determine how and when to deliver power to heater 120. For example, a PID controller can be used with temperature sensor 152 and heater 120 to automatically maintain the temperature set by a processor. Degasser 154 can be placed in line on the return leg of loop 150 to remove gases from the water to meet the required specifications for the water supply.

[0033] Various components within water supply system 100, such as valves, pumps, and heater 120 can be operated under processor control as discussed throughout. A controller 160 within system 100 includes this processor. Controller 160 includes the necessary non-volatile memory' for instruction and parameters, RAM, a processor, and the various driver circuits that can operate under processor control to deliver the appropriate signals to these elements. Thus, controller 160 can operate system 100 under processor control, allowing software to dictate temperature and timing of the delivery' of water.

[0034] During normal operation, controller 160 will manipulate heater 120 and pumps 114 and 138 to maintain a recirculating loop 150 to have a nominal temperature around that of the human body' (e.g., about 37 degrees Celsius). In some embodiments, this temperature is lower than that of the human body, around 32.5 degrees C. Accordingly, during normal operation, controller 160 will manipulate heater 120 and pumps 114 and 138 to maintain a recirculating loop 150 to have a temperature at a first threshold temperature configured to operate the system 100 within a normal or nominal operating temperature. In some embodiments, the first threshold temperature is below' 50 degrees Celsius. In some embodiments, the first threshold temperature is below 40 degrees Celsius, and may be between 25 and 40 degrees Celsius or may be between 30 and 35 degrees Celsius. For example, in one embodiment, when the first threshold temperature is reached or is within the first threshold temperature range, the controller 160 turns off the heater 120, and once the temperature is below the first threshold temperature (or outside the range) then the controller160 turns on the heater 120 until the temperature reaches the first temperature threshold in accordance with a suitable control profile, such as a PID control profile.

[0035] In various embodiments disclosed herein, controller 160 can also manipulate heater 120 so that the recirculating loop has a temperature above that of the human body (e.g., about 37 degrees Celsius) or around 32.5 degrees Celsius, depending on the application. While this temperature would not be ideal for normal operation of the various stations, raising the temperature above a higher temperature threshold can be used to sterilize and sanitize the components in water supply system 100. By raising the temperature above a pasteurization threshold (e g., to second threshold temperature that is higher than the first threshold temperature), water can be recirculated in loop 150 to sanitize the components of loop 150. The second threshold temperature may be any temperature higher than the first threshold temperature (i.e., operating temperature or temperature range) and configured to pasteurize the components in the water supply system 100. In one embodiment, the second threshold temperature may be above 40 degrees Celsius, or may be above 50 degrees Celsius. Once the temperature is raised to this second threshold temperature and held there for a set amount of time while recirculating, this water can then be dispensed via supply valves 132 and 142 to purge the high-temperature water while also sanitizing the downstream components from the manifolds. This includes the supply valves and the delivery tubing in stations 134 and 144. Once the processor (in controller 160) purges the high-temperature water from loop 150, inlet valve 106 can then be opened to refill tank 110. Heater 120 can be controlled to reestablish the nominal operating temperature of loop 150 (such as that of the human body) without requiring the water in loop 150 to cool.

[0036] By raising the temperature of recirculating loop 150 under processor control and then purging the manifolds via supply valves 142 and 132 under processor control, a processor can automatically sanitize the entire water supply system under software control during any maintenance break when the IVD system is not operating. This can be a routine that is done nightly, weekly, monthly, etc. This can also be done on demand when bacterial growth is suspected. Once bacterial growth happens in the water supply system, it is important to address the problem by sanitizing the water supply system promptly to avoid contaminating test results. Additionally, high-temperature water is an effective solvent for various chemical and particulate build-ups. Using software to routinely execute this cleaningand sanitizing cycle using heater 120 can extend the operating interval of the IVD equipment between manual maintenance breaks.

[0037] FIG. 2 is a three-dimensional rendering of an exemplary water supply system 100 within a single housing. Tank assembly 110 has an outlet that supplies low-pressure pump 114 to push water through inline filter 116 and water circulation heater 120, housing-mounted water manifolds 130 and 140 supply water to valve assemblies 132 and 142, Degasser 154, intervening high-pressure pump 138 between the two manifolds, outlet flow restrictor 148, and sensor / thermistor 152, before returning to tank 110. Also shown is water inlet valve 106 to supply freshwater to take 110 and w ater temperature thermistor / sensor 108.

[0038] Exemplary high-pressure stations include reagent arm probes, dilution arm probes, and sample arms probes. Each one of these stations generally needs the w ater supply to supply w ater at 50 psi with a flow rate of around 2 ml / sec. In some embodiments, high- pressure water can be delivered at 50 to 63 PSI. It is assumed that each station requires a flow rate between 1.5 and 2.5 ml per second. A PID controller can control the high-pressure pump to ensure that pressure meets the pressure requirements with a maximum pressure variation of less than tw o psi / sec.

[0039] The low-pressure manifold can supply high-flow water at 11 psi to wash drains to provide rinsing action to the outside of probes to prevent sample and reagent carryover and supply water for use in assays during normal operation. These drains can require a flow' of around 5.5 ml per second to 7.5 ml per second, with a maximum pressure variation in the manifold of one psi / sec.

[0040] An exemplary water supply system should be capable of supplying w ater with a dissolved gas content at 30° C of less than 6 ppm, high pressure supply of 55 to 60 psi + / - 2 psi. and 11 to 12 PSI + / - 1 psi to the high and low-pressure stations at a temperature between 23° and 37° C, 32.5° C nominal. Depending on the system requirements for the stations, the tolerance for the water supply is approximately + / - 1.5° C. Overall flow through loop 150 should be at least 4 1pm for an exemplary clinical chemistry and technology and IVD test system. Using the water supply with a temperature above 25° C greatly reduces reagent probe / mixer carryover for IVD stations.

[0041] Various heater designs can be used for heater 120. In a simple embodiment, a resistive heater using a 1100 Watt heating element is driven by AC lor DC voltage by a PIDcontroller through a relay to efficiently set and maintain water temperature. Higher powered heating elements can also be used to more quickly heat the water. FIGs. 3 and 3A show alternative embodiments of water heaters. One or more thermistors in the circulation loop can be used to monitor the performance of the heating element and the temperature of the water in the loop and provide feedback for a control loop. In some embodiments, a thermistor is integrated into the body of heater 120, while in other embodiments, the thermostat temperature can be placed at the output of the high or low-pressure manifolds. A thermistor at either location can provide feedback for a software-based or circuit-based control loop (e.g., PID control or a learning algorithm such as model predictive control) to set the water temperature for loop 150.

[0042] In exemplary heater 120, shown in FIG. 3, water comes in from the tank at inlet 162, passing through heating element 164 and optional temperature sensor 166 before exiting the heater at outlet 68. Heating element 164 can be a resistive heating element, a solid-state heating element, a heat pump, or any other reasonable heating element that meets the design requirements. Exemplar}' heater 120 should be able to deliver heat at 650 to 1100 Watts to quickly heat water. Heater 120 is controlled by controller 160 via I / O circuit 170. Circuit 170 can include a digital interface for interacting with controller 160 or an analog interface for analog control. In exemplary circuit 170, heating element 164 is controlled by a PID controller within circuit 170. PID controller utilizes a thermistor signal from temperature sensor 166 to set the output temperature at outlet 168 based on the requested target temperature received from controller 160 via a digital interface. In some embodiments, information from temperature sensor 166 is also passed to controller 160 via circuit 170 for supervision.

[0043] Heater 120a in FIG. 3A adds heating element 174. Heating element 174 can be in series or in parallel with heating element 164. These heating elements can have different characteristics, which can grant certain benefits. For example, using one powerful heating element and one less powerful heating element allows for high power ramp up of water temperature at system startup or when pasteurization is needed, while the lower power heating element can be used to maintain a set temperature more precisely and more efficiently.

[0044] In some embodiments, each heating element 164 and 174 is a pair of positive temperature coefficient (PTC) heating elements. This allows two predetermined set pointtemperatures to be used to selectively heat and maintain water temperature and two different selected set points. For example, one PTC heating element can be used during normal operation to maintain a temperature around 32.5° C. When a maintenance procedure is needed, the second PTC heater can be used with a set point around 55° to 60° C, providing pasteurization of water passing through heater 120 on demand. From a control standpoint, the processor simply needs to choose which heating element will be used at a given moment and the physics of the heating element will maintain the temperature passing through heater 120 at the set point temperature.

[0045] A PTC material is a material that exhibits a non-linear positive resistance change in response to a temperature increase. A heater that utilizes a PTC material is a selfregulating device that does not rely on external feedback control to maintain a particular temperature (the “threshold temperature”). The PTC heater draws current through a printed circuit, thereby increasing the temperature of the PTC material and giving off heat. As the temperature of the PTC material increases in a non-linear manner at a threshold temperature, the temperature of the overall PTC heater also increases, thereby restricting the current flow and abating heat generation. The PTC heater is designed such that a temperature and resistance equilibrium is reached at the desired threshold temperature. In other words, when the PTC heater is below the threshold temperature, resistance is lower and current is higher, producing more heat. When the PTC heater reaches the threshold temperature, the resistance of the PTC material rapidly increases relative to temperature such that any heat generation does not further increase the temperature of the PTC heater. The PTC heater does not require a control loop (e.g., temperature sensor, external controls, etc ); the PTC material is selfregulating by way of the relationship between temperature and resistance.

[0046] FIG. 4 shows an exemplary flow chart for operating system 100 to provide both a nominal operating temperature for IVD assay operation and a maintenance pasteurization temperature to clean and sanitize the water supply system. Method 200 begins at setup. This occurs when the system is first turned on. At this point, the reservoir is filled, and recirculation begins. Heater 120 is driven to heat the water to at least the normal operating temperature while the pumps circulate the water.

[0047] At step 204, controller 160 determines whether or not maintenance is needed. This decision can be based on various software routines or human input. For example, software can determine how long it has been since the last maintenance interval anddetermine if pasteurization is needed based on how long the system has been operating. Controller 160 can also determine whether or not there is an unexpected drift in IVD assay results, which may indicate that there may be particulate or bacterial drift in the water supply that may be addressed through pasteurization and a cleaning and sanitizing routine. In some embodiments, artificial intelligence learning algorithms learn when the system might benefit from a maintenance cycle based on any measured factors. A human operator can also check the bacterial content of water using vanous standard test methods (such as plate growth) and request a pasteurization procedure.

[0048] Most of the time, however, maintenance will not be needed, and normal operation can begin at step 205. During normal operation the water supply system maintains a temperature at a first or operating temperature which may be, for example, around 32.5° C ± 50C, and operates the high and low -pressure pumps to circulate water at the predetermined pressures, as described above. Water at this temperature can be used, for example, to assist in an assaying procedure during normal operation. At step 206, water is heated via heater 120 to the first temperature, such as 32.5° C (or another required operating temperature). At step 208, the high and low-pressure pumps circulate w ater in loop 150. At step 210, controller 160 opens and closes the various valves to deliver water from the manifolds to the stations, in accordance with the assaying routines, such as flushing probes with high pressure, rinsing basins with low pressure, and the like.

[0049] When maintenance is needed, such as when bacterial growth is suspected or time has passed to the point where preventative pasteurization should be done to inhibit bacterial growth, controller 160 proceeds to step 220 to begin a maintenance operation. At step 222. heater 120 heats the water in circulating loop 150 to a second or pasteurization temperature that is higher than the first temperature to be used during a maintenance procedure to remove bacteria build up. The second temperature may be, for example, 55° to 60° C ± 50C (or another temperature sufficient for pasteurization). In one embodiment, the second temperature may be 55° to 60° C. At step 224, the pump continues circulating this high- temperature water through the manifolds. In some embodiments, continuous recirculation of the high-temperature w ater can be 30 to 60 minutes to ensure pasteurization of the entire circulating loop. In some embodiments, step 222 includes intentionally draining part of the tank volume via a tank drain in tank 110 or via the manifolds, by sending water to stations to purge volume. The purpose of this is to reduce the volume of w ater in the recirculating loopso that the loop can be brought to pasteurization temperature faster with the heating element. For example, draining half the volume of the tank (and loop components) before the temperature is increased can reduce the rise time for the recirculation loop by nearly half.

[0050] At step 226, controller 160 operates various valves to deliver the high- temperature water to the different IVD stations. This can occur at any time during the continuous recirculation step. The purpose of opening these valves is twofold. First, it allows the pasteurization water to pass through the delivery tubing to the stations to pasteurize the inside of the tubing and the valves. Second, by purging the high-temperature water, the system can purge the hot water in tank 110 so that it can be refilled with colder ater and heated to operating temperature without waiting for the pasteurization water to cool. In some embodiments, this flushing step 226 can be repeated multiple times throughout the 30 to 60- minute maintenance interval, such that tank 110 is repeatedly filled from the municipal supply so that sufficient volumes of water can pass through the deliver}' tubing to the stations to pasteurize each one of them. At step 228, controller 160 determines if sufficient time has passed during the heating, circulating, and purging steps to pasteurize the necessary components. If so, maintenance is complete and operation returns to step 204, where it is determined that additional maintenance is not necessary so that normal operation can resume.

[0051] FIG. 5 shows the results of three pasteurization procedures using heater 120 in an exemplary system. One line tracks water temperature, while the other shows bacterial count grown from samples taken at different time intervals. In this exemplary system, the thermal ramp period took nearly 30 minutes to raise the temperature to 55° C due to power limitations. In some embodiments, a more powerful heating element can be employed (or a smaller volume tank) to raise the temperature more quickly. As can be seen, bacterial levels are generally reduced w ell before 55° C. In some embodiments, low er temperatures for the pasteurization temperature may be effective, such as around 40° C, depending on application and the duration. Here, by the time the water temperature has reached the target pasteurization temperature, bacteria is almost entirely mitigated. Because bacterial levels are nearly completely reduced by the time the w ater temperature reaches the target temperature, the amount of time that the w ater temperature is held there can be less than 30-60 minutes in some embodiments. Alternatively, higher temperatures can be used to instantly clean stations during the purging process.

[0052] Clinical Chemistry Analyzer Module

[0053] One type of analyzer module in an IVD system that can benefit from the systems and techniques disclosed herein is a clinical chemistry module. A clinical chemistry module will be explained with respect to a mid-volume clinical chemistry module (MVCC). A MVCC module is an instrument for performing automated clinical chemistry testing. The MVCC module can be installed as part of a larger analyzer system (e g., analyzer 30) which might include multiple MVCC and immunoassay (IA) modules. The MVCC module can also be connected directly to a laboratory sample distribution track via a direct connect laboratory automation system (LAS) interface module. The MVCC communicates with an LIS to gather and report status of patient samples as they are processed.

[0054] The primary function of the MVCC module is to provide clinical chemistry assays using photometric and IMT detectors. An integrated multisensor technology (IMT) system uses ion selective electrodes to measure electrolytes in serum, plasma, and urine samples. An exemplary' MVCC module is capable of processing a maximum of 1200 photometric assays per hour and up to 600 IMT results per hour (200 samples per hour with up to 3 electrolyte results per sample). The MVCC module includes a dilution system, an IMT (Ion Selective Electrode / ISE) system, reagent system and photometric system, and is supported via common base utilities for the MVCC module.

[0055] In some embodiments, the MVCC module has no inherent capability for loading samples and must be linked to a source / sink, such as the sample handler module or a direct load track section via the vessel mover system. The MVCC module takes one or more sample aliquots from a primary’ sample vessel that is positioned via the vessel mover system at an aliquot position accessible to a pipette of the MVCC module and stores them on-board for processing.

[0056] The MVCC module accesses samples from an automation track (or directly at a single position on the left side, in some embodiments). The MVCC reagent cartridge design includes features which permit transfer mechanism interface and automatic cap opening; this allows it to be “automation friendly”. This allows the MVCC module to receive reagent cartridges via the automation track of the vessel mover system and automatically move these reagent cartridges from the automation track to reagent storage onboard the MVCC module. This allows the automatic delivery of reagents to the MVCC module. In some embodiments, the MVCC module can load and unload reagents to a single position on the PCM track in the back of the module or to the manual load station in the front.

[0057] FIG. 6 is a domain model of MVCC module 300. Patient samples, calibrators samples, or control samples (together, samples) 302 are sample tubes delivered via a carrier and the vessel mover system to position 56, where the sample preparation system 304 can access the sample. Sample preparation system 304 includes a pipette arm that accesses a sample access point 56. Preparation system 304 then aspirates one or more aliquots from the sample on the automation track. Based on the identi ty of that sample it is determined by the MVCC module whether ISE testing or photometric testing is appropriate for that sample aliquot. In the case of ISE sample testing, the aliquot is delivered to ISE sample delivery system 306. ISE sample delivery system 306 includes a plurality7of aliquot vessels, such as cuvettes, to receive the sample aliquot for ISE testing. Delivery system 306 then delivers the diluted sample aliquot to the ISE testing module that performs a standard ISE test. The resulting data of this test is then presented to module control processor 312. Processor 312 is responsible for scheduling and managing all testing going on in the MVCC module 300.Processor 312 receives commands in test orders from an LIS or manually from an operator or test menu. Once test results are completed and presented to the processor, processor 312 reports these test results and any other status data, such as completeness of testing for that sample, to the LIS or a user interface or database.

[0058] If the sample is determined to need photometric testing, preparation system 304 presents the aliquot to the photometric sample delivery system 308. Photometric sample delivery system 308 can include a dilution ring that dilutes and stores aliquots of samples. Each photometric sample aliquot is then presented to photometric reaction system 314. This reaction system can include a reaction ring that receives samples and reagents according to a set time schedule and presents those mixed samples to photometer 316. Photometer 316 may take multiple photometric measurements of the mixed sample at a regular time interval or schedule to observe the reaction between reagents and the diluted sample. Photometer 316 then presents its findings as photometer data to module control processor 312.

[0059] Reagents can be delivered via a drawer on the front for manual delivery by an operator or by placing a reagent vessel at a predetermined location on the automation track, such as position 64. Reagent delivery system 322 receives reagents 320 from the reagent drawer or from the automation track and, using a robot arm or similar mechanical means, reagent delivery system 322 moves that reagent into a reagent storage area 324. In some embodiments, reagent delivery may require some type of preparation of that reagent by thereagent delivery7system 322. Reagent storage area 324 can be an environmentally / temperature-controlled storage area where vessels of reagents are stored to be delivered as reagent aliquots on demand to the reaction ring used by the photometric reaction system 314. When a reagent is needed for a photometric test, an aliquot of that reagent can be withdrawn from reagent storage area 324 and placed into a reagent vessel or cuvettes that is part of the reaction ring of photometric reaction system 314.

[0060] MVCC module 300 also receives electricity7and water from the laboratory. Water is used for cleaning and rinsing testing components to prevent cross contamination of samples or reagents. The result of testing and cleaning of equipment is liquid waste that must be evacuated by the laboratory and treated or flushed. Consumables, such as diluent, cuvettes, or disposable tips or reagent packaging are also presented to MVCC module 300. Once these consumables are used, they may be disposed by the MVCC module into a solid waste storage area (e.g., an internal trash bin), along with any empty7reagent cartridges. Once full, an operator can be alerted to empty the solid waste bin and dispose of the contents appropriately (such as by placing them in the laboratory trash or biohazardous waste bin).

[0061] The MVCC module uses two measurement techniques: photometric and Ion Selective Electrode (IMT / ISE). Photometric tests are performed by mixing a sample aliquot w ith one or two liquid reagents and measuring light transmitted through the reaction mixture at one or more w avelengths over a period of time up to 10 minutes. IMT tests are performed by mixing a sample aliquot with IMT diluent and passing the mixture past electrodes specific to the target ions (e.g., Na, K, and Cl).

[0062] In an exemplary embodiment, the MVCC module is capable of processing a maximum of 1,200 photometric assays per hour and up to 600 IMT results per hour (200 samples per hour with up to 3 electrolyte results per sample). All photometric and IMT assays are processed from diluted aliquots of the original sample. For photometric assays, the MVCC module prepares one or more dilutions depending on the dilution ratios of the specific tests for a sample and the amount of sample fluid needed.

[0063] For IMT assays, an aliquot of the original sample is delivered to the IMT module, which prepares the dilution internally. For IMT assays, the aliquot of original sample is added to a measured quantity of IMT diluent. The mixture is drawn through the module pastthe IMT chip and the voltage of each of the sensors is read. A measurement of IMT Standard A is taken immediately before or after each sample to provide reference readings.

[0064] Dilutions for photometric assays are stored on a dilution ring until needed by the MVCC test scheduling software. At the appropriate time(s) an aliquot of diluted sample is delivered into a reaction cuvette by the sample arm. In general, all photometric assays follow the same standard template: the first reagent is delivered into an empty reaction cuvette followed by sample addition and mixing. For most photometric assays a second reagent is added to the reaction mixture (and mixed) 4.3 minutes after sample addition. Photometric readings are taken at set times until the assay is complete (a maximum of 9.75 minutes). After all the photometric data has been collected the assay result is calculated using one of several available calculations.

[0065] Photometric dilution ring scheduling operates in two basic modes: Synchronous and Asynchronous. Synchronous scheduling mode is in operation when the IMT is busy or no IMT work is available. During synchronous operation photometric dilutions are being created from samples presented to the module. The dilution ring advances every 6 seconds, processing dilution cuvettes in sequence. While the dilution ring is stationary', various operations are performed around the ring, such as creating a new diluted aliquot, washing a dilution cuvette, mixing, etc. In some embodiments, each sample is transferred to up to two cuvettes on the reaction ring from a single dilution cuvette. To maintain synchronization with the reaction ring two photometric tests are scheduled for the dilution at the mix station so that when that dilution reaches the reaction sampling position the appropriate cuvettes are ready on the reaction ring. Any remaining tests required for the sample being scheduled (beyond two) are added to the list of pending work. If the particular dilution at the mix station has only one test requested, the second scheduled test is a generic CLEAN test.

[0066] Asynchronous scheduling mode is in operation when the IMT is idle and has work available or when the photometric pending work list gets too long or when high priority (STAT) photometric tests are available. During asynchronous operation, no new dilutions are created, and no washing or mixing is performed. In asynchronous mode, the dilution ring is able to move freely as needed in order to make the highest priority photometric test available for processing.

[0067] FIG. 7 shows the hardware systems in an exemplary' MVCC module 300 that may utilize the systems and techniques and systems disclosed herein. Samples are moved within an automated IVD system to sample access point 156 via a vessel mover system, such as patient sample tube conveyor system. Once presented, a sample may be aspirated via dilution arm 330. Dilution arm 330 is a robotic arm with a pipette configured to aspirate an aliquot of a sample. If that sample aliquot is designated by the control processor of module 300 for an ISE test, dilution arm 330 swings counterclockwise to position the pipette above and access port for IMT system 332. If the sample aliquot aspirated by dilution arm 330 is designated for photometric testing, dilution arm 330 rotates clockwise to position the pipette above dilution ring 334.

[0068] A diluter system includes dilution arm and probe 330, dilution ring 334, dilution mixer 336, and a dilution aliquot washer, along with support pumps and bulk fluid feet systems. The diluter system services the photometric system and the IMT System. The dilution arm 330 transfers the sample from the sample access point 56 on the PCM track to either the IMT System 332 or the dilution ring 334. Mixer 336 can utilize any of the structures and techniques of embodiments disclosed herein, such as mixers 50, 80, 82, 84, or 86.

[0069] For photometric assays, the dilution arm creates the necessary sample dilution(s) using saline solution. The normal dilution is 1 :5 but other dilutions are available depending upon assay requirements. An exemplary system also has the capability to perform serial dilutions (impacting throughput) at ratios up to 1:2500. The diluted sample is held for retest or reflexive testing on dilution ring 334 until that aliquot reaches the aliquot wash station. Under normal (number of tests / sample) circumstances the sample is available for more than 10 minutes.

[0070] For the IMT assays, dilution arm 330 performs serum and / or urine dilutions directly into the IMT port where the dilution is mixed. In this case the IMT specific diluent is delivered by a separate metering system.

[0071] IMT system 332 is responsible for testing a diluted sample using an appropriate electrode for the ISE test. Once the sample aliquot has been tested, IMT system 332 can then flush and clean the internal vessel used to test that sample portion. The results of the IMTtesting are then sent to module control processor 312. IMT system 332 includes ISE module310 from FIG. 10.

[0072] IMT system 332 processes samples (serum or urine) delivered to the IMT port by dilution arm 330. IMT diluent is metered into the entry port where it is mixed with the sample. The diluted sample is drawn into the detection electrode "‘stack” where the concentration of the target ions (Na, K, Cl) is measured. Reference fluid(s) can be automatically pumped into the “stack” to perform periodic calibrations. This system operates on an 18 second cycle to process 200 samples per hour for a nominal throughput of 600 assays per hour.

[0073] Dilution ring 334 includes a series of disposable or cleanable vessels / cuvettes. Once dilution ring 334 has received a sample aliquot, that ring rotates the cuvettes until each cuvette having a sample reaches the dilution mixer 336 to perform a final mix of the diluted sample, making the sample suitable for photometric testing. Dilution ring 334 continues rotating clockwise until that sample is in a position that can be accessed by sample arm 338. It should be appreciated that dilution ring 334 can act as a random-access sample ring, allowing STAT samples to be moved directly from the interaction point with dilution arm 330 dilution mixer 336 and then to a position accessible to sample arm 338.

[0074] Sample arm 338 is responsible for aspirating the dilute sample portion prepared by dilution mixer 336, moving above a reaction ring 340, and dispensing that sample portion into reaction cuvettes in that reaction ring. In some embodiments, reaction ring 340 can include a plurality of concentric rings each holding a plurality of cuvettes with samples and reagents. These rings can be moved relative to one another to allow reagents to be aspirated and dispensed into reaction vessels containing samples. In some embodiments, a single ring is used. Reagents can be added before the sample arrives or after the sample arrives via reagent arm 342 or reagent arm 344.

[0075] The primary7function of reagent arms 342 and 344 is to move aliquots of reagents from reagent sen7er 346 or reagent server 345, respectively. These aliquots are then dispensed into reaction vessels in reaction ring 340. In some embodiments, the vessel receiving aliquot contains a patient sample; in some embodiments the vessel is empty, and the patient sample will be added later. Reagent servers 345 and 346 include a variety of different reagents, allowing a variety7of tests to be performed by MVCC module 300.Reaction ring 340 moves vessels in a predetermined sequence such that each reaction vessel reaches reagent mixer 348 or sample mixer 350 for mixing. Reagent mixer 348 can be used to premix reagents from reagent servers 345 and 346 or combination reagents. Sample mixer 350 is used to mix reaction vessels containing both reagent and sample. Once mixed, the reaction between the sample and reagent proceeds in the reaction vessel. Reaction ring 340 rotates to allow photometer 352 to take photometric measurements of the reaction at predetermined times. In some tests, additional reagents need to be added by reagent arms 342 and 344 at a predetermined time, the new solution mixed, and additional photometric measurements taken.

[0076] In some embodiments, the photometric system processes the photometric assays in 221 optical cuvettes on reaction ring 340. The system supports the traditional fixed assay templates used in other MVCC modules in the art. Reaction ring 340 indexes 75 cuvette positions every 3 seconds. Using this indexing pattern, a given cuvette advances 4 cuvette positions every third index. The system can initiate a new photometric test every 3 seconds yielding a nominal throughput of 1200 assays per hour.

[0077] Assay resources include reagent- 1 delivery, sample delivery', reagent mix-1, reagent-2 delivery and reagent mix-2 all at fixed points in time. The reactions are conducted in semi-permanent cuvettes that are washed and re-used after each assay by a cuvette washer. Assays are processed in reaction cuvettes held at constant (37°C) temperature on reaction ring 340 through the use of a heated fluid bath. The system processes assays on a 3 second cycle.

[0078] The assay is initiated with addition of the first reagent (Rl) by reagent arm 344. Shortly thereafter, a precision sampler (e.g. sample arm 338) transfers sample from an aliquot on the dilution ring 334 to the reaction cuvette. The contents are then mixed thoroughly with reagent mixer 348 or sample mixer 350 and a reaction ensues. The reaction cuvette is read by photometer 352 approximately once every 9 seconds while reaction ring 340 is indexing.The photometer 352 uses a standard set of 1 1 wavelengths currently used by similar photometers in the art. Photometer 352 supports absorbance and turbidimetric assays using the 11 available wavelengths.

[0079] Some assays only require a single reagent while others require a second reagent addition. The second reagent is added by reagent arm 342 at a fixed point in time (e.g.,approximately 260 seconds after sample addition) and the reaction is mixed by reagent mixer348 or sample mixer 350. The reaction is read by the photometer as before.

[0080] Reagent servers 346 and 345 contain a series of radially oriented reagent vessels placed in two concentric rings. These reagent vessels can be loaded via reagent loader 354. Reagent loader 354 includes a robot arm that moves on a gantry’ that allows it to be positioned above the vessel mover access point 64 on the automation track. The mechanical components of the reagent loader 354 can be substantially the same as those discussed with respect to robot arm 20, configured to interact with reagent cartridges. When a reagent within reagent server 345 or 346 needs to be refilled, the servers will automatically eject the empty cartridge, and the vessel mover system will retrieve a replacement reagent cartridge and position that cartridge via a carrier at the vessel mover access point 64. Reagent loader 354 will then move to that position and pick up the reagent cartridge using end effectors. Reagent loader 354 will then move that reagent cartridge to the appropriate empty slot in reagent server 345 or 346 and insert the cartridge into that location in the reagent server.

[0081] Alternatively, an operator can manually load reagents at the request of the machine or at a predetermined schedule. The operator can load a series of reagent cartridges into a tray at reagent manual load station 356. Reagent manual load station 356 includes a linear slide that receives the tray and moves the tray into position underneath reagent loader 354. End effectors of the robot arm of the reagent loader can then remove reagent cartridges from the tray place at the reagent manual load station 356 and move those cartridges into the appropriate slot in the reagent servers. This allows automatic or manual loading of reagents.

[0082] Reagents are stored and provided by the reagent system. The reagent system includes two refrigerated rotary’ reagent servers. One server (345) is dedicated solely to the first reagent addition and one (346) to the second reagent addition. Each server operates on a 3 second cycle with about 1 second allocated for motion and 2 seconds allocated for access by the respective reagent arms. Each reagent server holds reagent cartridges arranged in two concentric rings. There are 24 cartridges on the inner ring and 46 cartridges on the outer for a total cartridge capacity of 70. In some embodiments, up to four positions on each server can be dedicated to cartridges holding special cleaning fluids and one position can be held open for loading and unloading logistics. This means an exemplary system can simultaneously support 65 different on-board assays.

[0083] Reagent cartridges are loaded into the servers by reagent loader 354. Reagent loader 354 presents the reagent cartridge to a barcode reader to confirm the identity of the cartridge (PCM track load at position 64) or to identify the cartridge (reagent manual load station 356). Reagent loader 354 then places the cartridge in the appropriate server position (in server 345 or 346).

[0084] The reagent cartridge is sized for ease of handling by the PCM and has gripping features to allow pickup using reagent loader 354 and a PCM reagent handler (e.g. a robot arm). The cartridge is closed with a screw-on cap with auto-open features. One or more bar- coded labels are provided for identification by the customer and the system. The cartridge has dual wells with 25 ml capacity in each well. The dual well configuration can allow for longer on-board stability by only opening each well as needed.

[0085] The reagent cartridge is closed with a screw-on cap that can be opened either by the customer (in the case of the need for pre-hydrating the reagent) or automatically by the system. This cap should maintain a hermetic seal for long-term storage but be easily opened in use. This closure system is auto-open only with no provision to re-seal the opened cap. A foil seal is designed for piercing by reagent loader 354.

[0086] The embodiments of the present disclosure may be implemented with any combination of hardware and software. In addition, the embodiments of the present disclosure may be included in an article of manufacture (e.g., one or more computer program products) having, for example, computer-readable, non-transitory media. The media has embodied therein, for instance, computer readable program code for providing and facilitating the mechanisms of the embodiments of the present disclosure. The article of manufacture can be included as part of a computer system or sold separately.

[0087] While various aspects and embodiments have been disclosed herein, other aspects and embodiments will be apparent to those skilled in the art. The various aspects and embodiments disclosed herein are for purposes of illustration and are not intended to be limiting, with the true scope and spirit being indicated by the following claims.

[0088] An executable application, as used herein, comprises code or machine-readable instructions for conditioning the processor to implement predetermined functions, such as those of an operating system, a context data acquisition system or other information processing system, for example, in response to user command or input. An executableprocedure is a segment of code or machine-readable instruction, sub-routine, or other distinct section of code or portion of an executable application for performing one or more particular processes. These processes may include receiving input data and / or parameters, performing operations on received input data and / or performing functions in response to received input parameters, and providing resulting output data and / or parameters.

[0089] A graphical user interface (GUI), as used herein, comprises one or more display images, generated by a display processor and enabling user interaction with a processor or other device and associated data acquisition and processing functions. The GUI also includes an executable procedure or executable application. The executable procedure or executable application conditions the display processor to generate signals representing the GUI display images. These signals are supplied to a display device which displays the image for viewing by the user. The processor, under control of an executable procedure or executable application, manipulates the GUI display images in response to signals received from the input devices. In this way, the user may interact with the display image using the input devices, enabling user interaction with the processor or other device.

[0090] The functions and process steps herein may be performed automatically or wholly or partially in response to user command. An activity (including a step) performed automatically is performed in response to one or more executable instructions or device operation without user direct initiation of the activity.

[0091] While various illustrative embodiments incorporating the principles of the present teachings have been disclosed, the present teachings are not limited to the disclosed embodiments. Instead, this application is intended to cover any variations, uses, or adaptations of the present teachings and use its general principles. Further, this application is intended to cover such departures from the present disclosure that are within known or customary practice in the art to which these teachings pertain.

[0092] In the above detailed description, reference is made to the accompanying drawings, which form a part hereof. In the drawings, similar symbols typically identify similar components, unless context dictates otherwise. The illustrative embodiments described in the present disclosure are not meant to be limiting. Other embodiments may be used, and other changes may be made, without departing from the spirit or scope of the subject matter presented herein. It will be readily understood that various features of thepresent disclosure, as generally described herein, and illustrated in the Figures, can be arranged, substituted, combined, separated, and designed in a wide variety of different configurations, all of which are explicitly contemplated herein.

[0093] Aspects of the present technical solutions are described herein with reference to flowchart illustrations and / or block diagrams of methods, apparatuses (systems), and computer program products according to embodiments of the technical solutions. It will be understood that each block of the flowchart illustrations and / or block diagrams, and combinations of blocks in the flowchart illustrations and / or block diagrams, can be implemented by computer readable program instructions.

[0094] These computer readable program instructions can be provided to a processor of a general-purpose computer, special purpose computer, or other programmable data processing apparatus to produce a machine, such that the instructions, which execute via the processor of the computer or other programmable data processing apparatus, create means for implementing the functions / acts specified in the flowchart and / or block diagram block or blocks. These computer readable program instructions can also be stored in a computer readable storage medium that can direct a computer, a programmable data processing apparatus, and / or other devices to function in a particular manner, such that the computer readable storage medium having instructions stored therein comprises an article of manufacture including instructions which implement aspects of the function / act specified in the flowchart and / or block diagram block or blocks.

[0095] The computer readable program instructions can also be loaded onto a computer, other programmable data processing apparatus, or other device to cause a series of operational steps to be performed on the computer, other programmable apparatus or other device to produce a computer implemented process, such that the instructions which execute on the computer, other programmable apparatus, or other device implement the functions / acts specified in the flowchart and / or block diagram block or blocks.

[0096] The flowchart and block diagrams in the figures illustrate the architecture, functionality, and operation of possible implementations of systems, methods, and computer program products according to various embodiments of the present technical solutions. In this regard, each block in the flowchart or block diagrams can represent a module, segment, or portion of instructions, which includes one or more executable instructions for implementingthe specified logical function(s). In some alternative implementations, the functions noted in the blocks can occur out of the order noted in the figures. For example, two blocks shown in succession can, in fact, be executed substantially concurrently, or the blocks can sometimes be executed in the reverse order, depending upon the functionality involved. It will also be noted that each block of the block diagrams and / or flowchart illustration, and combinations of blocks in the block diagrams and / or flowchart illustration, can be implemented by special purpose hardware-based systems that perform the specified functions or acts or carry out combinations of special purpose hardware and computer instructions.

[0097] A second action can be said to be “in response to'’ a first action independent of whether the second action results directly or indirectly from the first action. The second action can occur at a substantially later time than the first action and still be in response to the first action. Similarly, the second action can be said to be in response to the first action even if intervening actions take place between the first action and the second action, and even if one or more of the intervening actions directly cause the second action to be performed. For example, a second action can be in response to a first action if the first action sets a flag and a third action later initiates the second action whenever the flag is set.

[0098] The present disclosure is not to be limited in terms of the particular embodiments described in this application, which are intended as illustrations of various features. Many modifications and variations can be made without departing from its spirit and scope, as will be apparent to those skilled in the art. Functionally equivalent methods and apparatuses within the scope of the disclosure, in addition to those enumerated herein, will be apparent to those skilled in the art from the foregoing descriptions. It is to be understood that this disclosure is not limited to particular methods, reagents, compounds, compositions or biological systems, which can, of course, vary'. It is also to be understood that the terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting.

[0099] With respect to the use of substantially any plural and / or singular terms herein, those having skill in the art can translate from the plural to the singular and / or from the singular to the plural as is appropriate to the context and / or application. The various singular / plural permutations may be expressly set forth herein for sake of clarity.

[0100] It will be understood by those within the art that, in general, terms used herein are generally intended as ’open" terms (for example, the term ‘"including” should be interpreted as ‘"including but not limited to,” the term "‘having” should be interpreted as ‘"having at least,” the term “includes” should be interpreted as “includes but is not limited to,” et cetera). While various compositions, methods, and devices are described in terms of “comprising"’ various components or steps (interpreted as meaning “including, but not limited to”), the compositions, methods, and devices can also “consist essentially of’ or “consist of’ the various components and steps, and such terminology should be interpreted as defining essentially closed-member groups.

[0101] As used in this document, the singular forms “a,” “an,” and “the” include plural references unless the context clearly dictates otherwise. Unless defined otherwise, all technical and scientific terms used herein have the same meanings as commonly understood by one of ordinary skill in the art. Nothing in this disclosure is to be construed as an admission that the embodiments described in this disclosure are not entitled to antedate such disclosure by virtue of prior invention.

[0102] In addition, even if a specific number is explicitly recited, those skilled in the art will recognize that such recitation should be interpreted to mean at least the recited number (for example, the bare recitation of “two recitations,” without other modifiers, means at least two recitations, or two or more recitations). Furthermore, in those instances where a convention analogous to “at least one of A, B, and C, et cetera” is used, in general such a construction is intended in the sense one having skill in the art would understand the convention (for example, “a system having at least one of A, B. and C” would include but not be limited to systems that have A alone, B alone, C alone, A and B together, A and C together, B and C together, and / or A, B, and C together, et cetera). In those instances where a convention analogous to “at least one of A, B, or C, et cetera"’ is used, in general such a construction is intended in the sense one having skill in the art would understand the convention (for example, “a system having at least one of A, B, or C” would include but not be limited to systems that have A alone, B alone, C alone, A and B together, A and C together, B and C together, and / or A, B, and C together, et cetera). It will be further understood by those within the art that virtually any disjunctive word and / or phrase presenting two or more alternative terms, whether in the description, sample embodiments, or drawings, should be understood to contemplate the possibilities of including one of the terms,either of the terms, or both terms. For example, the phrase "A or B” will be understood to include the possibilities of “A” or “B” or "A and B.”

[0103] In addition, where features of the disclosure are described in terms of Markush groups, those skilled in the art will recognize that the disclosure is also thereby described in terms of any individual member or subgroup of members of the Markush group.

[0104] As will be understood by one skilled in the art, for any and all purposes, such as in terms of providing a written description, all ranges disclosed herein also encompass any and all possible subranges and combinations of subranges thereof. Any listed range can be easily recognized as sufficiently describing and enabling the same range being broken down into at least equal halves, thirds, quarters, fifths, tenths, et cetera. As a non-limiting example, each range discussed herein can be readily broken dow n into a lower third, middle third and upper third, et cetera. As will also be understood by one skilled in the art all language such as ‘"up to,” "at least,” and the like include the number recited and refer to ranges that can be subsequently broken down into subranges as discussed above. Finally, as wall be understood by one skilled in the art, a range includes each individual member. Thus, for example, a group having 1-3 components refers to groups having 1, 2, or 3 components. Similarly, a group having 1-5 components refers to groups having 1, 2, 3, 4. or 5 components, and so forth.

[0105] Independent of the grammatical term usage, individuals with male, female or other gender identities are included within the term. Various of the above-disclosed and other features and functions, or alternatives thereof, may be combined into many other different systems or applications. Various presently unforeseen or unanticipated alternatives, modifications, variations or improvements therein may be subsequently made by those skilled in the art, each of which is also intended to be encompassed by the disclosed embodiments.

[0106] The system and processes of the figures are not exclusive. Other systems, processes and menus may be derived in accordance with the principles of the technology' to accomplish the same objectives. Although this technology has been described with reference to particular embodiments, it is to be understood that the embodiments and variations shown and described herein are for illustration purposes only. Modifications to the current design may be implemented by those skilled in the art, w ithout departing from the scope of the invention. As described herein, the various systems, subsystems, agents, managers andprocesses can be implemented using hardware components, software components, and / or combinations thereof. No claim element herein is to be construed under the provisions of 35 U.S.C. 112(f) unless the element is expressly recited using the phrase “means for.”NON-LIMITING ILLUSTRATIVE EMBODIMENTS

[0107] The following is a list of non-limiting illustrative embodiments disclosed herein:

[0108] Illustrative embodiment 1. A water supply system, comprising: a reservoir configured to hold water; a recirculating loop configured to recirculate water to and from the reservoir comprising: a pump, a water heater, and a manifold configured to supply water to a plurality of stations via a plurality of electrically controllable valves; and a processor configured to operate the recirculating loop under software control to: perform an assaying procedure, whereby the water heater heats the water to a temperature between 30 and 35 degrees Celsius and recirculating water is discharged from the manifold to the lurality of stations in accordance with an assaying procedure, and perform a maintenance procedure to kill bacteria, whereby the water heater raises the temperature of recirculating water above 50 degrees Celsius, holds the temperature for a predetermined amount of time, and the plurality of electrically controllable valves purge the water through the plurality of stations.

[0109] Illustrative embodiment 2. The water supply system of illustrative embodiment 1, wherein the water heater comprises a first PTC heater with a first threshold of 30-35 degrees Celsius and a second PTC heater with a second threshold above 50 degrees Celsius.

[0110] Illustrative embodiment 3. The water supply system of any one of illustrative embodiments 1-2, wherein the water heater comprises a resistive heating element controlled by a PID controller.[OHl] Illustrative embodiment 4. The water supply system of any preceding illustrative embodiment, wherein the processor is further configured to refill the reservoir with fresh water that is at or below 30-35 degrees Celsius after the maintenance procedure.

[0112] Illustrative embodiment 5. The water supply system of any preceding illustrative embodiment, wherein the processor is further configured to discharge the water above 50 degrees Celsius individually to each of the plurality of stations such that bacteria is killed in lines between each station and the manifold.

[0113] Illustrative embodiment 6. The water supply system of any preceding illustrative embodiment, wherein the processor is further configured to discharge a portion of the water prior to the water heater raising the temperature of recirculating water above 50 degrees Celsius such that a time needed to heat the water is reduced.

[0114] Illustrative embodiment 7. A method of operating a water supply system, comprising: filling a reservoir with water; providing a recirculating loop configured to recirculate water to and from the reservoir, the loop comprising a pump, a water heater, and a manifold configured to supply water to a plurality' of stations via a plurality' of electrically controllable valves; operating the recirculating loop under software control to: perform an assaying procedure, whereby the water heater heats the water to a temperature between 30 and 35 degrees Celsius and recirculating water is discharged from the manifold to the plurality7of stations in accordance with an assaying procedure, and perform a maintenance procedure to kill bacteria, whereby the w ater heater raises the temperature of recirculating water above 50 degrees Celsius, holds the temperature for a predetermined amount of time, and the plurality of electrically controllable valves purge the water through the plurality of stations.

[0115] Illustrative embodiment 8. The method of any preceding illustrative embodiment, wherein the water heater comprises a first PTC heater w ith a first threshold of 30-35 degrees Celsius and a second PTC heater with a second threshold above 50 degrees Celsius.

[0116] Illustrative embodiment 9. The method of any preceding illustrative embodiment, wherein the water heater comprises a resistive heating element controlled by a PID controller.

[0117] Illustrative embodiment 10. The method of any preceding illustrative embodiment, wherein the step of operating the recirculating loop further comprises refilling the reservoir with fresh water that is at or below 30-35 degrees Celsius after the maintenance procedure.

[0118] Illustrative embodiment 11. The method of any preceding illustrative embodiment, wherein the step of operating the recirculating loop further comprises discharging the water above 50 degrees Celsius individually to each of the plurality of stations such that bacteria is killed in lines betw een each station and the manifold.

[0119] Illustrative embodiment 12. The method of any preceding illustrative embodiment, wherein the step of operating the recirculating loop further comprises discharging a portion of the water prior to the water heater raising the temperature of recirculating water above 50 degrees Celsius such that a time needed to heat the water is reduced.

[0120] Illustrative embodiment 13. A method of operating the recirculating loop water system under software control comprising steps of: during a normal operation, heating recirculating water to a first temperature between 30 and 35 degrees Celsius, recirculating the water to a manifold, and selectively discharging the water to a plurality of stations, each having a drain; and during a maintenance procedure, killing bacteria by heating the recirculating water to a second temperature of the recirculating water above 50 degrees Celsius and holding the temperature for a predetermined amount of time, and purging the water through the plurality of stations via one or more valves.

[0121] Illustrative embodiment 14. The method of any preceding illustrative embodiment, wherein the step of heating the recirculating water to the first temperature comprises heating water with a first PTC heater (164) with a first threshold of 30-35 degrees Celsius and the step of heating the recirculating water to the second temperature comprises heating water with a second PTC heater (174) with a second threshold above 50 degrees Celsius.

[0122] Illustrative embodiment 15. The method of any preceding illustrative embodiment, wherein the steps of heating the recirculating water to the first temperature and to the second temperature comprises heating water with a resistive heating element controlled by a PID controller.

[0123] Illustrative embodiment 16. The method of any preceding illustrative embodiment, further comprising a step of refilling the reservoir with fresh water that is at or below 30-35 degrees Celsius after the maintenance procedure.

[0124] Illustrative embodiment 17. The method of any preceding illustrative embodiment, wherein the step of purging the water comprises discharging the water above 50 degrees Celsius individually to each of the plurality of stations such that bacteria is killed in lines between each station and the manifold.

[0125] Illustrative embodiment 18. The method of any preceding illustrative embodiment, further comprises a step of discharging, prior to the step of heating the recirculating water to a second temperature, a portion of the recirculating water such that a time needed to heat the water is reduced.

Claims

CLAIMSWhat is claimed is:1 . A water supply system, comprising: a reservoir configured to hold water; a recirculating loop configured to recirculate water to and from the reservoir comprising: a pump, a water heater, and a manifold configured to supply water to a plurality of stations via a plurality of electrically controllable valves; and a processor configured to operate the recirculating loop under software control to: perform an assaying procedure, whereby the water heater heats the water to a temperature between 30 and 35 degrees Celsius and recirculating water is discharged from the manifold to the plurality of stations in accordance with the assaying procedure, and perform a maintenance procedure to kill bacteria, whereby the water heater raises the temperature of recirculating water above 50 degrees Celsius, holds the temperature for a predetermined amount of time, and the plurality of electrically controllable valves purge the water through the plurality of stations.

2. The water supply system of claim 1, wherein the water heater comprises a first PTC heater with a first threshold of 30-35 degrees Celsius and a second PTC heater with a second threshold above 50 degrees Celsius.

3. The water supply system of claim 1, wherein the water heater comprises a resistive heating element controlled by a PID controller.

4. The water supply system of claim 1, wherein the processor is further configured to refill the reservoir with fresh w ater that is at or below730-35 degrees Celsius after the maintenance procedure.

5. The w ater supply system of claim 1, wherein the processor is further configured to discharge the w ater above 50 degrees Celsius individually to each of the plurality7of stations such that bacteria is killed in lines between each station and the manifold.

6. The water supply system of claim 1, wherein the processor is further configured to discharge a portion of the water prior to the w ater heater raising the temperature of recirculating w ater above 50 degrees Celsius such that a time needed to heat the water is reduced.

7. A method of operating a water supply system, comprising: filling a reservoir with water; providing a recirculating loop configured to recirculate water to and from the reservoir, the loop comprising a pump, a w ater heater, and a manifold configured to supply water to a plurality of stations via a plurality of electrically controllable valves; operating the recirculating loop under software control to: perform an assaying procedure, whereby the water heater heats the water to a temperature between 30 and 35 degrees Celsius and recirculating water isdischarged from the manifold to the plurality of stations in accordance with an assaying procedure, and perform a maintenance procedure to kill bacteria, whereby the water heater raises the temperature of recirculating water above 50 degrees Celsius, holds the temperature for a predetermined amount of time, and the plurality' of electrically controllable valves purge the water through the plurality' of stations.

8. The method of claim 7, wherein the water heater comprises a first PTC heater with a first threshold of 30-35 degrees Celsius and a second PTC heater with a second threshold above 50 degrees Celsius.

9. The method of claim 7, wherein the water heater comprises a resistive heating element controlled by a PID controller.

10. The method of claim 7, wherein the step of operating the recirculating loop further comprises refilling the reservoir with fresh water that is at or below 30-35 degrees Celsius after the maintenance procedure.

11. The method of claim 7, wherein the step of operating the recirculating loop further comprises discharging the water above 50 degrees Celsius individually to each of the plurality of stations such that bacteria is killed in lines between each station and the manifold.

12. The method of claim 7, wherein the step of operating the recirculating loop further comprises discharging a portion of the water prior to the water heater raising the temperatureof recirculating water above 50 degrees Celsius such that a time needed to heat the water is reduced.

13. A method of operating the recirculating loop water system under software control comprising steps of: during a normal operation, heating recirculating water to a first temperature between 30 and 35 degrees Celsius, recirculating the water to a manifold, and selectively discharging the water to a plurality7of stations, each having a drain; and during a maintenance procedure, killing bacteria by heating the recirculating water to a second temperature of the recirculating water above 50 degrees Celsius and holding the temperature for a predetermined amount of time, and purging the water through the plurality of stations via one or more valves.

14. The method of claim 13, wherein the step of heating the recirculating water to the first temperature comprises heating water with a first PTC heater (164) with a first threshold of 30-35 degrees Celsius and the step of heating the recirculating water to the second temperature comprises heating water with a second PTC heater (174) with a second threshold above 50 degrees Celsius.

15. The method of claim 13. wherein the steps of heating the recirculating water to the first temperature and to the second temperature comprises heating water with a resistive heating element controlled by a PID controller.

16. The method of claim 13, further comprising a step of refilling the reservoir with fresh water that is at or below 30-35 degrees Celsius after the maintenance procedure.

17. The method of claim 13, wherein the step of purging the water comprises discharging the water above 50 degrees Celsius individually to each of the plurality' of stations such that bacteria is killed in lines between each station and the manifold.

18. The method of claim 13, further comprises a step of discharging, prior to the step of heating the recirculating water to a second temperature, a portion of the recirculating water such that a time needed to heat the water is reduced.

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