JP7546824B2 - Control of a water treatment device via a dialysis machine user interface - Patent Application 20070123333 - Google Patents

Description

[Priority claim]
No. 13/030,909 (now U.S. Pat. No. 8,216,452), entitled "Dialysis System Including Multi-Heater Power Coordination," filed Feb. 18, 2011, which is a continuation of U.S. patent application Ser. No. 12/031,605 (now U.S. Pat. No. 7,892,423), entitled "Dialysis System Including Multi-Heater Power Coordination," filed Feb. 14, 2008, the entire contents of each of which are incorporated herein by reference. This application claims priority to and the benefit of U.S. patent application Ser. No. 13/494,259, filed Jun. 12, 2012, entitled "Multi-Heater Power Coordination."

[0002] The present disclosure relates generally to renal therapy systems, and more particularly to systems and methods for controlling water treatment devices exclusively through dialysis machines.

[0003] The human renal system can fail due to disease, injury, or other causes. Whatever the cause of kidney failure, there are several physiological derangements. Kidney failure results in the inability to balance water and minerals and to excrete the daily metabolic load. During kidney failure, harmful end products of nitrogen metabolism (e.g., urine, creatinine, uric acid, etc.) can accumulate in the blood and tissues.

[0004] Kidney failure and reduced kidney function are treated with dialysis, which removes waste products, toxins, and excess water from the body that would otherwise be removed by normally functioning kidneys in a healthy individual. For many people, dialysis is a life-saving alternative to kidney function and is important. People with impaired kidneys may not be able to survive without at least a replacement for the filtration function of the kidneys.

[0005] Hemodialysis and peritoneal dialysis are two types of dialysis therapies commonly used to treat loss of kidney function. Hemodialysis treatments use the patient's blood to remove waste, toxins, and excess water from the patient. The patient is connected to a hemodialysis machine, which pumps the patient's blood. A catheter or needle is inserted into the patient's circulatory system to connect the blood flow to the hemodialysis machine. The blood and dialysate pass through the dialyzer of the hemodialysis machine. The dialyzer may include a semi-permeable membrane that separates the blood from the dialysate. As the blood passes through the dialyzer of the hemodialysis machine, the dialyzer removes waste, toxins, and excess water from the patient's blood. In particular, toxins are transferred from the blood through the membrane by osmotic pressure into the dialysate. The hemodialysis machine returns this blood to the patient. A large amount of dialysate is used to dialyze the blood during one hemodialysis treatment, for example, about 120 liters. The used dialysate is then discarded. Hemodialysis treatments last several hours and are generally performed about three or four times a week at a treatment center.

[0006] Peritoneal dialysis uses a dialysis solution or "dialysate" that is infused into the patient's peritoneal cavity through a catheter implanted in the cavity. The dialysate comes into contact with the patient's peritoneal membrane within the cavity. Waste, toxins, and excess water move from the patient's bloodstream through the peritoneal membrane and into the dialysate. The transfer of waste, toxins, and water from the bloodstream to the dialysate occurs by diffusion and osmosis; that is, an osmotic gradient is created across the membrane. Spent dialysate is drained from the patient's peritoneal cavity, removing waste, toxins, and excess water from the patient. The cycle is repeated.

[0007] There are various types of peritoneal dialysis therapy, including continuous ambulatory peritoneal dialysis (CAPD), automated peritoneal dialysis, and continuous flow peritoneal dialysis. CAPD is a manual dialysis procedure in which the patient connects an implanted catheter to a drain to allow spent dialysate to drain from the peritoneal cavity. The patient then connects the catheter to a bag of fresh dialysate and manually injects fresh dialysate through the catheter into the patient's peritoneal cavity. The patient disconnects the catheter from the bag of fresh dialysate, allowing the dialysate to dwell in the peritoneal cavity and transfer waste, toxins, and excess water from the patient's bloodstream into the dialysate. After the dwell period, the patient repeats the manual dialysis procedure.

[0008] In CAPD, patients perform several drain/fill/dwell cycles during the day, for example, about four times per day. Each treatment cycle typically takes about one hour. Manual peritoneal dialysis performed by the patient requires significant time and effort. This inconvenient procedure leaves considerable room for improvement and therapeutic enhancements to improve the quality of life for patients.

[0009] Automated peritoneal dialysis (APD) is similar to CAPD in that the dialysis treatment involves drain/fill/dwell cycles. However, APD machines perform three or four peritoneal dialysis treatments automatically, usually at night while the patient sleeps. APD machines are fluidly connected to an implanted catheter. APD machines are also fluidly connected to a source or bag of fresh dialysate and a fluid drain.

[0010] An APD machine pumps fresh dialysate from a dialysate source through a catheter into the patient's peritoneal cavity and allows the dialysate to dwell in the cavity so that waste products, toxins, and excess water can be transferred from the patient's bloodstream to the dialysate. The APD machine then pumps used dialysate from the peritoneal cavity through the catheter to a drain. APD machines are typically computer controlled so that the dialysis treatment occurs automatically when the patient is hooked up to the dialysis machine, for example while the patient is asleep. That is, the APD system automatically and continuously pumps fluid into the peritoneal cavity, allows it to dwell, withdraws fluid from the cavity, and repeats the process.

[0011] As with the manual process, several drain/fill/dwell cycles are performed during APD. A "last fill" is typically used at the end of APD so that fluid remains in the patient's peritoneal cavity when the patient is disconnected from the dialysis machine for the day. APD frees the patient from having to manually perform the drain, dwell, and fill steps.

[0012] For kidney disease patients, frequent dialysis is a part of life. Most peritoneal dialysis patients dialyze once a day. Hemodialysis patients typically require dialysis several times a week. Home dialysis is increasingly required to allow patients to live as normal a life as possible. Peritoneal dialysis is typically performed at home. Hemodialysis and other blood treatment therapies such as hemofiltration are often performed in centers and clinics.

[0013] Performing dialysis at home, whether hemodialysis or peritoneal dialysis, increases the difficulties and complications for the patient. Typically, dialysis is performed using a dialysis machine and a fluid supply. The fluid supply may be prepared in one or more prepared solution bags or may be prepared online via a water treatment device and concentrated additives. In the case of a water treatment device, the dialysis machine and water treatment device are operated simultaneously to successfully perform the treatment. Operating two machines or devices can be difficult, especially for elderly or immobile patients who may not be able to quickly observe and/or operate both devices. Viewing information on and/or inputting information into two devices can also be cumbersome. Both the dialysis machine and the water treatment device generate data that may be desirable to store for analysis. This data must be accurate, timely, and provide sufficient detail.

[0014] Therefore, there is a need for a home dialysis system that integrates a water treatment device with a hemodialysis machine to centralize control of both machines or devices and to facilitate data exchange with both machines or devices.

[0015] The disclosed system and method integrates the operation of the dialysis machine and the water treatment device such that the user essentially operates the water treatment device from the dialysis machine. That is, the user interface with the water treatment device is the user interface that controls the dialysis machine. The water treatment device may have its own small user interface, but the primary control of the water treatment device is through the dialysis machine. It also contemplates transferring data from both machines to a central repository maintained by the care provider, providing treatment data reports to clinicians for both the dialysis machine and the water treatment device, integrating with payment and ordering systems, tracking consumable usage and delivering consumables as needed, and servicing and maintaining the machines on the system's network. To this end, in one embodiment, the dialysis machine is in data flow communication with the water treatment device via Ethernet or other wired communication. The dialysis machine is in communication with the system or network. In this manner, data from the water treatment device can be transmitted to the network or system via the dialysis machine. The system or network can similarly transmit operating instructions and software upgrades to the water treatment device via the dialysis machine.

[0016] Dialysis machines include home therapy machines such as, but not limited to, home hemodialysis (HD) machines, home peritoneal dialysis (PD) machines, home hemofiltration (HF) machines, home hemodiafiltration (HDF) machines, and home continuous renal replacement (CRRT) machines. While renal therapy is one focus of the present disclosure, the present disclosure also contemplates the integration of any home fluid delivery therapy, such as home drug delivery therapy or nutritional therapy. In various embodiments, home therapy is any type of therapy with medical fluids that can be generated on-line or on-the-fly from a source of purified water, such as ultrapure water, as that term is understood in the art. For example, while PD is typically performed with bagged dialysate, it is contemplated to instead generate an on-line PD solution from a source of ultrapure or sterile water and add PD concentrates, such as dextrose or glucose concentrates, as needed.

[0017] It is also contemplated that the home treatment may be a nutritional therapy in which purified water from the water treatment device is used as a base for preparing a nutritional solution to be delivered to the patient. In either situation, all control of the water treatment device is through the same user interface that is used to control the home treatment machine, which in one embodiment is a blood processing home treatment machine, a PD home treatment machine, or a home nutritional treatment machine.

[0018] It is also contemplated that the home medical device system transfers treatment prescriptions to the home therapy machine. A physician's prescription for renal or other type of home therapy is created. A clinician can remotely select supplies to be sent to the patient's home based on the physician's prescription, including supplies for both the home therapy machine and the water treatment device. The clinician can also remotely set operating parameters for operating both the home therapy machine and the water treatment device. The operating parameters of both the home therapy machine and the water treatment device are transmitted to the home therapy machine. The operating parameters of the home therapy machine are stored in a memory of the therapy machine. The operating parameters of the water treatment device are transferred by the home therapy machine to the water treatment device and stored in a memory of the water treatment device.

[0019] The disclosed systems and methods also allow for firmware upgrades of the home therapy machine and water treatment device via the home therapy machine. Once the upgraded firmware is generated, it is sent to the home therapy machine. If the new firmware is for the home therapy machine, it is installed on the home therapy machine. If the new firmware is for the water treatment device, the home therapy machine transfers the new firmware to the water treatment device, where it is installed. In certain jurisdictions, software upgrades, whether for the home therapy machine or the water treatment device, may require the user to accept the upgrade. In either case, it is contemplated that the user may accept the new firmware, whether for the home therapy machine or the water treatment device, at the user interface of the home therapy machine.

[0020] It is also contemplated that the operating prescription and new firmware may be provided with tags that specify whether the home therapy machine or the water treatment device is to receive the operating instructions or firmware. Alternatively, the instructions and firmware may inherently appear to be or have content that is specific to either the home therapy machine or the water treatment device. In the latter case, the home therapy machine may determine whether it will accept the instructions or firmware upgrade itself or forward it to the water treatment device based on the unique characteristics detected. No additional tags are required here.

[0021] Based on the above and following discussion, it should be appreciated that an advantage of the present disclosure is to provide improved home therapeutic treatment with on-line generation of purified water.

[0022] Another advantage of the present disclosure is that it provides improved hemodialysis, hemofiltration, hemodiafiltration, peritoneal dialysis, drug delivery and nutrition home therapy systems and methods.

[0023] Yet another advantage of the present disclosure is to provide an improved system and method for transmitting operating parameters to multiple machines or devices in a home treatment system.

[0024] Yet another advantage of the present disclosure is that it allows clinicians, doctors, and nurses to remotely review and monitor data generated by multiple machines or devices working together to provide home care.

[0025] Yet another advantage of the present disclosure is that it provides an improved system and method for transmitting firmware upgrades to multiple machines or devices that work together to provide home therapy.

[0026] Yet another advantage of the present disclosure is that it ensures that data is exchanged in a reliable and secure manner between a server and multiple machines or devices working together to provide home therapy.

[0027] Yet another advantage of the present disclosure is that it prevents data from being sent from a server to multiple machines or devices working together to provide home therapy while the machines or devices are operating.

[0028] Additionally, an advantage of the present disclosure is that it allows a user to control features of procedures involving multiple machines or devices using a single user interface.

[0029] Additional features and advantages are described herein or will become apparent from the following detailed description and drawings.

FIG. 1 is a schematic block diagram illustrating one embodiment of a home medical device system according to the present disclosure. FIG. 1 is a block diagram illustrating one embodiment of a computing device for use in a home medical device system according to the present disclosure. FIG. 1 is a block diagram illustrating one embodiment of a dialysis machine with a water purification unit of a home medical device system according to the present disclosure. FIG. 2 is a schematic diagram illustrating one embodiment of a subsystem including a water treatment device in communication with a home therapy machine for a home medical device system according to the present disclosure. 1 is a flow chart illustrating an exemplary process for installing a water treatment device according to the present disclosure. 1 is a flow diagram illustrating an exemplary process for producing water using a water treatment device according to the present disclosure. 1 is a flow chart illustrating an exemplary process for starting up a home therapy machine and water treatment device according to the present disclosure. 4 is a flow chart illustrating an exemplary process for updating components in a water treatment device according to the present disclosure. 1 is a flow diagram illustrating an exemplary process for transporting inventory and programming a home therapy machine and/or water treatment device treatment prescription based on an approved treatment prescription according to the present disclosure. 1 is a flow chart illustrating an exemplary process for upgrading firmware in a home therapy machine and/or a water treatment device according to the present disclosure. 1 is a screen shot illustrating an example dashboard screen for a clinic according to the present disclosure. 11 is a screen shot showing an example legend for a dashboard screen according to the present disclosure. 13 is a screen shot illustrating an exemplary treatment summary screen, according to the present disclosure. 13 is another screen shot showing an exemplary treatment summary screen according to the present disclosure. 1 is a screen shot showing an example patient usage report according to the present disclosure.

Home Medical Device Systems
[0045] Referring now to the drawings, and in particular to Figure 1A, there is shown a home medical device system 110. System 110 shows a home therapy machine 100, which may be of any type, such as a home hemodialysis (HD) machine, a home hemofiltration (HF) machine, a home hemodiafiltration (HDF) machine, a home peritoneal dialysis (PD) machine, a home drug delivery machine, or a home nutrition therapy machine. When home therapy machine 100 is a home hemodialysis machine, one suitable machine is described in U.S. Patent Application Publication No. 2009/0101549, entitled "Modular Assembly For A Hemodialysis System," filed August 27, 2008, the contents of which are hereby incorporated by reference in their entirety.

[0046] Although one home therapy machine 100 is shown in communication with the connectivity server 118, the system 110 oversees the operation of multiple home therapy machines 100 of the same or different types. For example, there may be M hemodialysis machines 100, N hemofiltration machines 100, O hemodiafiltration machines 100, P peritoneal dialysis machines 100, Q home drug delivery machines 100, and R home nutrition therapy machines 100 connected to the server 118 and operating with the system 110. The numbers M through R may be the same or different and may be zero, one, or multiple.

[0047] In the illustrated embodiment, the home therapy machine 100 receives purified water at its front end from a water treatment device 10. One suitable water treatment device 10 is described in U.S. Patent Application Publication No. 2011/0197971, entitled "Water Purification System and Method," filed April 25, 2011, which application is hereby incorporated by reference in its entirety. In one embodiment, the water treatment device 10 outputs ultrapure water, as that term is understood in the art. The ultrapure water may be passed through one or more filters, such as ultrafiltration membranes or dialyzers, to produce water of or near injection or pharmaceutical quality. This injectable quality water can then be mixed with one or more dry, liquid or slurry concentrates to produce (i) an injectable replacement solution for HF or HDF, (ii) a PD solution, (iii) a drug for injection, or (iv) a nutrient solution for injection.

[0048] In system 110, home therapy machine 100 is shown operating with other devices in addition to water treatment device 10, such as blood pressure monitor 104, a scale, e.g., wireless scale 106, and wireless tablet user interface 122. Home therapy machine 100, in one embodiment, wirelessly connects to server 118 via modem 102. Each of these components, including water treatment device 10, is generally located within the patient's home, as shown by the dashed lines in FIG. 1A. Any one, any more, or all of components 10, 104, 106, and 122 may communicate with home therapy machine 100 in a wired or wireless manner. Wireless communication may be via Bluetooth, WiFi, Zigbee, Z-Wave, wireless universal serial bus (USB), infrared, or other suitable wireless communication technology. Alternatively, any one, any multiple, or all of components 10, 104, 106, and 122 may communicate with the home therapy machine 100 via wires.

[0049] In one embodiment, the water treatment device 10 connects to the home therapy machine 100 via an Ethernet cable. In one embodiment, the water treatment device 10 is powered from its own power source. The home therapy machine 100 can request water from the water treatment device 10 as needed. The water treatment device 10 is sized and configured to provide any amount of water required by the machine 100 on-line or in batches.

[0050] The connectivity server 118 communicates with most of the home medical device system 110 via a home medical device system hub 120. The system hub 120 allows data and information regarding each of the home therapy machines 100 and water treatment devices 10 on the system 110 to pass between the machines 100 and other clients connected to the server 118 via the connectivity server 118. In the illustrated embodiment, the system hub 120 is connected to a service portal 130, an enterprise resource planning system 140, a web portal 150, a business intelligence portal 160, a HIPAA compliant database 124, a product development team 128, and electronic medical record databases 126a-126n.

[0051] Electronic medical record (EMR) databases 126a-126n store electronic information about patients. System hub 120 can transmit data collected from machine 100 log files, described in more detail below, to hospital or clinic databases 126a-126n to merge or supplement the patient's medical record. Because databases 126a-126n can store patient-specific treatment and prescription data, access to these databases can be highly restricted. Enterprise resource planning system 140 acquires and compiles data generated through patient and clinician website access, such as complaints, payment information, and lifecycle management information. Web portal 150 provides access to the system 110's publicly available website for patients and clinics 152a-152n who treat them. Business intelligence portal 160 collects data from system hub 120 and provides it to marketing 162, research and development 164, and quality/pharmacovigilance 166.

System Block Diagram
[0052] A block diagram of one embodiment of the electrical system of any one or more or all of the machines, devices or subsystems of the home medical device system (e.g., water treatment device 10, machine 100, modem 102, blood pressure monitor 104, scale 106, server 118, system hub 120, user interface 122, service portal 130, enterprise resource planning system 140, web portal 150, business intelligence portal 160) is shown in Figure IB. System 110, including any or all of the devices or subsystems 10, 100, 102, 104, 106, 118, 120, 122, 130, 140, 150 and 160, includes a main unit 170, which in one embodiment includes one or more processors 176, other computer circuitry 172, and one or more interface circuits 180 electrically coupled to one or more memory devices 174 by an address/data bus 178. Processor 176 may be any suitable processor, such as the INTEL PENTIUM® series of microprocessors. Memory 174 may include volatile and non-volatile memory. Memory 174 may store one or more software programs that interact with other devices in system 110 as described below. Memory 174 may also store digital data representing documents, files, programs, web pages, etc. retrieved from another computing device and/or loaded via input device 194.

[0053] The interface circuit 180 may be implemented using any suitable interface standard, such as an Ethernet interface and/or a USB interface. One or more input devices 194 may be connected to the interface circuit 180 to input data and commands to the main unit 170. For example, the input device 194 may be a keyboard, a mouse, a touch screen, a trackpad, a trackball, an isopoint, and/or a voice recognition system. The interface circuit 180 may be connected to any type of network 182, such as the Internet, a local area network (LAN), a telephone line (POTS), and/or other networks.

[0054] One or more displays, printers, speakers and/or other output devices 192 may also be connected to the main unit 170 via the interface circuitry 180. The display 192 may be a cathode ray tube (CRT), liquid crystal display (LCD) or any other type of display. The display 192 generates visual displays of data generated during operation of the devices or subsystems 10, 100, 102, 104, 106, 118, 120, 122, 130, 140, 150 and/or 160. For example, the display 192 may be used to display information received from the system hub 120. The visual displays may include prompts for human input, run-time statistics, calculated values, data, etc.

[0055] One or more storage devices 190 may also be connected to the main unit 170 via the interface circuitry 180. For example, a hard drive, a CD drive, a DVD drive, and/or other storage devices may be connected to the main unit 170.

[0056] It should be understood that the disclosed methods and procedures described herein can be implemented using one or more computer programs or computer components. These components can be provided as a series of computer instructions on any conventional computer-readable medium, such as random access memory (RAM), read-only memory (ROM), flash memory, magnetic or optical disks, or other storage media. These instructions can be configured to be executed by a processor that, when executing the series of computer instructions, performs or facilitates the execution of all or a portion of the disclosed methods and procedures.

Data transfer for water treatment equipment
[0057] In one embodiment, home therapy machine 100 performs a home treatment, such as home hemodialysis, on a patient in the patient's home and then reports the results of the treatment to clinicians, doctors, and nurses responsible for managing the patient's health and well-being. The results of the treatment include data provided to home therapy machine 100 from water treatment device 10. The data from water treatment device 10 may include, for example, the total volume of water delivered, the quality of the delivered water (e.g., chlorine content), the number of times water treatment device 10 delivered water to therapy machine 100 during a treatment (this data may be monitored by device 10 or machine 100), the average flow rate of water delivered, any alarms or warnings generated by water treatment device 10 during a treatment, and/or the time or number of cycles performed during a treatment, for example to obtain component replacement information.

[0058] The home therapy machine 100 writes log files, for example using a Linux operating system. The log files document relevant home therapy machine 100 data and relevant water treatment device 10 data again during treatment. The log files may include any one or more of an extensible markup language (XML), comma separated value (CSV) or text file. The log files are located in a file server box in the home therapy machine 100 software. Data that is not sent to the machine 100 is intended to be stored at the water treatment device 10. Alternatively, such data may be obtained via an Ethernet data connection to the water treatment device 10 or downloaded via other data connection or storage medium. For example, a service person may access the additional data via a laptop connected to the water treatment device 10 via an Ethernet connection. Alternatively, the additional data may be remotely retrieved from the water treatment device 10, with the home therapy machine 100 acting as a data transfer connection between the water treatment device 10 and authorized system clients as described herein.

[0059] The home therapy machine 100 uses a connectivity service, for example over the Internet, to transfer data, such as data from the water treatment device 10, between the modem 102 and the system hub 120. In one embodiment, each patient's home is provided with a dedicated line to connect the home therapy machine 100 to the connectivity server 118 via the modem 102. In one embodiment, the home therapy machine 100 accesses the Internet using a separate modem 102, for example 3G, 4G or 5G. The modem 102 utilizes an Internet Service Provider (ISP), such as Vodafone™. In one implementation, a connectivity agent 114 developed by a connectivity service provider (e.g., the provider of the connectivity server 118) is installed on the home therapy machine 100 and runs on the primary control processor (ACPU) 112. One suitable connectivity service is provided by Axeda™. The connectivity service provides a secure, managed connection 116 between the medical device and the connectivity server 118.

[0060] The connectivity agent 114 allows the home therapy machine 100 to connect to the connectivity server 118 and transfer data, such as data for the water treatment device 10, to and from the connectivity server 118. The connectivity service, operating through the agent 114 and the server 118, ensures that the connection with the machine 100 is secure, ensures that data passes correctly through the machine 100 firewall, checks if a data or system crash has occurred, and checks and ensures that the connectivity server 118 is communicating with the correct home therapy machine 100.

[0061] In one embodiment, the home therapy machine 100 can only connect to the connectivity server 118 when the connectivity agent 114 is turned on. During treatment and post-treatment sterilization while the machine 100 and water treatment device 10 are functioning, the connectivity agent 114 is turned off. This prevents the home therapy machine 100 from communicating with any entity to send or receive data during treatment and sterilization or when the machine 100 is powered on or operational. When the home therapy machine 100 is idle, such as after treatment and post-sterilization are completed, the ACPU 112 turns on the connectivity agent 114. In one embodiment, the connectivity agent 114 is turned off only during treatment (including pre-treatment). The connectivity agent 114 then retrieves log files from the home therapy machine 100 and transfers data, such as water treatment device 10 data, to the connectivity server 118 using the connectivity service. The connectivity service routes the data packets to the appropriate destination but, in one embodiment, does not modify, access or encrypt the data.

1A, connectivity services via connectivity server 118 can communicate data to various locations via system hub 120, service portal 130, and web portal 150. The connectivity server 118 allows service personnel 132a-132n and/or clinicians to track and retrieve various assets on the network, such as appropriate home therapy machines 100 and 3G, 4G, or 5G modems 102, and information related to those assets, such as machine or modem serial numbers. The connectivity server 118 can also be used to receive and provide firmware upgrades approved by service personnel supervisor 134 and obtained remotely via service portal 130 to authorized home therapy machines 100 and associated water treatment devices 10.

[0063] In one embodiment, connectivity agent 114a (not shown) can be installed on water treatment device 10 as well as on home therapy machine 100. In the event that home therapy machine 100 is unable to communicate with system hub 120 and system hub 120 needs to communicate with water treatment device 10, water treatment device 10 can communicate directly with system hub 120 via connectivity agent 114a. Alternatively, connectivity agent 114a can be installed on a separate device or unit (not shown) that can be selectively connected to water treatment device 10 such that, for example, if home therapy machine 100 loses communication with system hub 120, water treatment device 10 can be redirected back to communicating directly with system hub 120.

Water treatment equipment inspection
[0064] In one embodiment, home therapy machine 100 may be operated in a service mode where service personnel may access both home therapy machine 100 and water treatment device 10 on-site and/or at a remote location to diagnose and troubleshoot both. For example, a patient may be able to call a service person or technician if water treatment device 10 experiences a problem or a component thereof, such as a chemical pack, is depleted. The patient and/or service personnel then place water treatment device 10 via home therapy machine 100 in a service mode where the service technician may remotely verify the settings and functionality of water treatment device 10 with respect to various components of water treatment device 10. In one embodiment, system 110 pauses treatment to improve safety while a service technician is attending to machine 100. For example, service personnel may be able to log on to device 10 via machine 100 while treatment is paused. Alternatively, machine 100 must be idled or powered off to allow service personnel to access machine 100 and/or device 10. Alternatively, the machine 100 may simply need to be disconnected from the patient to allow service personnel access to the machine 100 and/or device 10 .

[0065] Once accessed, the service technician can remotely inspect and retrieve log files stored on the home therapy machine 100 to determine the cause of errors occurring on the water treatment device 10. The service technician may also be able to switch valves and activate pumps to determine whether relevant sensors, such as pressure sensors, of the water treatment device 10 are operating properly and/or whether valves or pumps of the water treatment device 10 are operating properly. The service technician does this by sending a command to the home therapy machine 100. The home therapy machine 100 recognizes that this command is intended for the water treatment device 10 and passes the command to a processor/memory of the water treatment device 10, thereby causing the appropriate operation of the water treatment device 10. The water treatment device 10 sends response data back to the home therapy machine 100, which relays this information back to the appropriate service technician.

[0066] The requests sent by the service personnel can be structured such that the machine 100 inherently knows whether the request is for the home therapy machine 100 or the water treatment device 10. Alternatively, the requests can be tagged. For example, the valves of the home therapy machine 100 can be numbered sequentially starting with 1, and the valves of the water treatment device 10 can be numbered sequentially starting with 100 (assuming that the home therapy machine 100 has less than 100 valves). Now, it is inherently known to pass a request to switch valve 111 to the water treatment device 10. Alternatively, the valves of both the home therapy machine 100 and the water treatment device 10 can be numbered sequentially starting with 1, but the requests can be coded, e.g., "A" for the home therapy machine 100 and "B" for the water treatment device 10. Now, the ACPU 112 of the home therapy machine 100 holds the request to switch valve AV4 and knows to pass a request to switch valve BV4 to the water treatment device 10.

Control via one user interface
[0067] In one embodiment, the control processor (ACPU 112) and user interface 122 of the home therapy machine 100 guide the patient through the entire treatment process and provide step-by-step instructions on how to initiate and perform treatment, including instructions to operate the water treatment device 10. In one embodiment, the user interface 122 is a tablet that implements a customized secure interface that only allows access to the home therapy machine 100. In one implementation, the tablet 122 operates wirelessly, where the tablet 122 can be initially connected to the home therapy machine 100 to pair the tablet 122 with the home therapy machine 100 and perform software (e.g., firmware) upgrades of the tablet 122. The tablet 122 can also be connected to the home therapy machine 100 to power or charge the tablet 122. The connectivity between the tablet 122 and the home therapy machine 100 can be via a serial data connection, a universal serial bus (USB) connection, a parallel connection, or another suitable data transfer interface. When the tablet 122 is paired with the home therapy machine 100, the tablet 122 communicates wirelessly with the home therapy machine 100 (eg, using Bluetooth® or WiFi™).

[0068] Alternatively, the user interface 122 may be connected or coupled to the machine 100, for example, as shown and described in U.S. Patent Application Publication No. 2009/0114582, the entire contents of which are relied upon by this application and incorporated herein by reference in their entirety. A connection or coupling configuration for the user interface 122 is described below as shown in FIG. 3.

[0069] In one embodiment, a user can send data to and receive data from machine 100 via tablet 122. Data entered into user interface 122 is securely transmitted to home therapy machine 100 and processed by ACPU 112, which controls machine 100 or transmits commands that are processed by water treatment device 10, which in turn controls the operation of portions of water treatment device 10. In one embodiment, treatment data is not stored on tablet 122. Not storing treatment data on tablet 122 is advantageous because confidential or important data is not lost if tablet 122 is disconnected or lost.

[0070] Because the user interface 122 of the home therapy machine 100 is also used to enter and display data related to the water treatment device 10, the water treatment device 10 does not require, and in one embodiment does not have, more than a simple display that may include a membrane switch and some electromechanical buttons such as an on/off switch. This simple display may be a small liquid crystal display (LCD) or light emitting diode (LED) display that displays one or a few lines of text. The electromechanical buttons allow for emergency control of the water treatment device 10 in the event that the tablet 122 is lost or communication between the home therapy machine 100 and the water treatment device 10 is lost. Alternatively or additionally, the electromechanical buttons allow installation or servicing of the water treatment device 10 without the home therapy machine 100 being present. The electromechanical buttons may also allow service personnel to enter a service mode directly from a small keypad, for example by pressing and holding a hidden button for a certain number of seconds.

[0071] In one embodiment, a user can power and unpower the home therapy machine 100 and/or the water treatment device 10 from the common user interface 122. The user can send commands to the water treatment device 10 from the common user interface 122. The commands can, for example, request that the water treatment device 10 provide an estimate of the time until consumable components of the water treatment device 10 will need replacing. For example, the water treatment device 10 can include a carbon filter, a sediment removal cartridge, a moderation filter, a reverse osmosis (RO) membrane, or a metal catalyzed filter, each of which will need replacing after a certain amount of use. As is conventional, the commands from the tablet 122 can be unique to the water treatment device 10 such that the ACPU 112 has no choice but to forward the command to the water treatment device 10. Alternatively, the commands can include a code that the ACPU 112 recognizes, based on which the ACPU 112 can responsively forward the command to the water treatment device 10.

[0072] One objective of the present disclosure is to prevent a user from having to view two different user interfaces when performing a home therapy treatment with system 110. In addition to having user interface 122 be one common user interface, it is also contemplated that water treatment device 10 requires as little user interaction as possible. For example, water treatment device 10 can be configured to remain powered indefinitely without adverse effects to water treatment device 10. Alternatively, home therapy machine 100 and water treatment device 10 can be configured such that water treatment device 10 receives power whenever home therapy machine 100 is powered. Similarly, many commands to home therapy machine 100 can carry over to water treatment device 10 or automatically have a secondary effect on water treatment device 10. For example, input of a pause or stop from user interface 122 to home therapy machine 100 can similarly cause home therapy machine 100 to automatically issue a pause or stop command to water treatment device 10. In another example, if an alarm condition occurs while the home therapy machine 100 is receiving purified water from the water treatment device 10, the home therapy machine 100 can stop drawing water from the water treatment device 10.

[0073] The operating parameters of the home therapy machine 100 may also define the operating parameters of the water treatment device 10. For example, in the area of hemodialysis, the flow rate of the dialysate or dialysate inputted into the home therapy machine 100 as an operating parameter may define the flow rate at which the water treatment device 10 is commanded to produce purified water used to produce the dialysate or dialysate. This configuration of leading/following operating parameters may be implemented in a number of different ways. In one way, the ACPU 112 of the home therapy machine 100 calculates or finds the operating parameters of the water treatment device 10 via a look-up table based on the corresponding operating parameters of the home therapy machine 100. For example, the ACPU 112 may store setting the flow rate of the purified water to 1.2 times the flow rate of the dialysate. During run-time, the ACPU 112 calculates and adjusts the flow rate of the purified water knowing the current actual or currently commanded flow rate of the dialysate of the home therapy machine 100. In one embodiment, the ACPU 112 may adjust the flow rate of the purified water if it determines that the patient needs a bolus of fresh solution. One suitable method for providing a patient with a bolus of fresh solution is described in U.S. Patent Application Publication No. 2009/0124963, entitled "Balanced Flow Dialysis Machine," filed November 9, 2007, the entire contents of which are incorporated herein by reference.

[0074] In a second method, the control processor of the water treatment device 10 calculates or finds the operating parameters of the water treatment device 10 via a look-up table based on the corresponding operating parameters of the home therapy machine 100 transmitted to the water treatment device 10 from the home therapy machine 100. For example, the control processor of the water treatment device 10 may store the purified water flow rate set to 1.2 times the dialysate flow rate. The ACPU 112 periodically transmits the current dialysate flow rate to the water treatment device 10, and the water treatment device 10 calculates and adjusts the purified water flow rate on the fly, knowing the current actual or currently commanded dialysate flow rate of the home therapy machine 100.

[0075] In a third method, the control processor of the water treatment device 10 is off-prescription in the same manner as the home therapy machine 100. The following describes a process in which the home therapy machine 100 receives one or more machine operation prescriptions from a doctor or clinician remotely via the server 118 and system hub 120 described above. When a machine operation prescription is installed in the ACPU 112 of the home therapy machine 100, it is accompanied by a set of instructions or secondary prescriptions that are transferred from the ACPU 112 to the control processor of the water treatment device 10. When the prescription of the home therapy machine 100 is then invoked by a user for treatment with the home therapy machine 100, the corresponding set of instructions or secondary prescriptions is invoked for use with the water treatment device 10. In this third method, data updates between the home therapy machine 100 and the water treatment device 10 during treatment can be reduced or eliminated.

[0076] A fourth method operates on a batch or volumetric basis. The home therapy machine 100 can include a dialysate holding tank. The ACPU 112 can be configured to generate dialysate when the volume of the tank drops to a certain level and to stop generating dialysate when the volume of dialysate in the tank rises to a certain level. The water treatment device 10 is now tasked with providing enough water to raise the low dialysate volume in the tank to a high dialysate volume in the tank, in response to concerns about dialysate flow rate to the dialyzer. When the tank volume is at a low level, the ACPU 112 activates the water treatment device 10 and the dialysate mixing pump of the home therapy machine 100 to generate dialysate and fill the dialysate holding tank. The water treatment device 10 and the dialysate mixing pump remain activated until a specified high tank volume is reached. It is contemplated that the water treatment device 10 and the dialysate mixing pump can maintain different dialysate production rates and increase their dialysate production rates when the water treatment device 10 and the dialysate mixing pump are not able to meet the demand due to low production rates. When the ACPU 112 increases or decreases the dialysate production rate, both the water treatment device 10 and the dialysate mixing pump are adjusted accordingly.

[0077] Although the lead/follow operating parameter configuration has been described using dialysate flow rate/purified water flow rate and/or volume control, it is expressly contemplated to use this configuration with other parameters, such as parameters related to the pressure, temperature and/or purity level of the water exiting the water treatment device 10.

[0078] Referring now to FIG. 2, an exemplary dialysis machine 100a includes a water purification unit 10a, a dialysate preparation unit 224, a dialysate delivery unit 230, and a sterilization unit 226. In one embodiment, the controller 232 includes multiple controllers, each including a processor/memory. The controller 232 includes, for example, a master or supervisor processor that controls multiple delegate processors, each dedicated to a different function related to the dialysis machine 100a. The controller 232 may also include redundant processors, such as a safety processor that ensures that each of the other processors performs its function correctly.

[0079] The controller 232 may control any one or more of the water purification unit 10a, the dialysate preparation unit 224, and the sterilization unit 226, as well as the heater 234, the pump 236, the valves 238, and the sensors 240. The home therapy machine and the water treatment device are shown separately in FIG. 1A, but may be located in the same housing as shown in FIG. 2. In one embodiment, the same user interface 122 may be used to control the controller 232, which may control any one or more of the various units, e.g., the home therapy machine and the water treatment device. The dialysis machine 100a may be powered by the branch power source 212 and/or the auxiliary power source 214.

Data Connection
[0080] Reference is now made to Figure 3, which illustrates a subsystem 50 of system 110 between water treatment device 10 and home therapy machine 100. For reference, the above-mentioned simple display and electro-mechanical buttons of water treatment device 10 are shown as display 20 and electro-mechanical buttons 22. Alternatively, water treatment device 10 may include only display 20 and only rudimentary input devices. The display of water treatment device 10 may enhance user interface 122. The control processor/memory of water treatment device 10 is shown as processor/memory 24. Also, as discussed above, user interface 122 of home therapy machine 100 is shown as being coupled or connected to home therapy machine 100. Alternatively, user interface 122 is an untethered tablet as discussed herein above.

3, a data communication link 32, such as, for example, Ethernet or wired communication, is provided to transmit data between the processing unit/memory 24 of the water treatment device 10 and the ACPU 112 of the home therapy machine 100. In one example, the water treatment device 10 uses the link 32 to transmit home therapy machine 100 status or condition information, component life information, sensor levels or readings, self-test results, warning and alarm information, and hardware and/or software version information. The water treatment device 10 can also provide information regarding the water flow between the water treatment device 10 and the home therapy machine 100, such as flow rate information, water temperature information, and line connection disinfection information.

3, data communication link 32 may also be used to transmit data between ACPU 112 of home therapy machine 100 and processor/memory 24 of water treatment device 10. As described above, or in addition to the above, home therapy machine 100 may transmit state change requests, commands (e.g., run, pause, or stop), status inquiries, flow rate change requests, software upgrades or downgrades, and/or data regarding file transfers, such as, for example, device prescriptions, to water treatment device 10.

[0083] As described herein, the user interface 122 presents information regarding the water treatment device 10 to the user 12. For example, the user interface 122 may display information such as alarm or warning notifications, water treatment device performance information, troubleshooting help, task guidance, and/or action requests to the user 12. For example, the user 12 may request, via the user interface 122, the water treatment device 10 to identify itself, ensure that the data connection means 32 between the machine 100 and the device 10 is functioning properly, and verify compatibility, such as compatibility of hardware and software versions between the device 10 and the machine 100. In that case, the device 10 itself may issue an audible beep or response and/or send a confirmation message back to the user interface 122, such as, for example, "I'm here." The user 12 may then take the appropriate action via the user interface 122 or by performing some task as indicated by the user interface 122. To do this, the user 12 need only interact with the common user interface 122. In this manner, the user 12 only needs to minimally interact with the water treatment device 10, such as performing hard power ons and power offs, making physical data and power connections, changing filters and/or performing manual measurements, while ensuring that the water treatment device 10 is functioning properly and in communication with the machine 100.

[0084] In addition to the data connection 32 between the home therapy machine 100 and the water treatment device 10, there is a water supply line 34 that runs from the water treatment device 10 to the home therapy machine 100. The water supply line 34 delivers water at a specified level of sterility, flow rate, pressure and/or temperature to the home therapy machine 100. The water delivered from the water treatment device 10 to the home therapy machine 100 is typically maintained at between about 5°C and 35°C. In one embodiment, the line 34 may also be used to return unused water product from the home therapy machine 100 to the water treatment device 10.

[0085] In one embodiment, the processing unit/memory 24 of the water treatment device 10 acts as a slave or delegate processor to the programmed ACPU 112 of the home therapy machine 100. The water treatment device 10 may inform the home therapy machine 100 of device conditions, such as alarm conditions, and send any other relevant data to the ACPU 112. The home therapy machine 100 stores the data and acts on it, for example determining whether to generate an alarm. Thus, the home therapy machine 100 controls the behavior of the water treatment device 10.

[0086] Water treatment device 10 may be in any one of several different states, such as "installation", "system flush", "sleep" or "treatment". Home therapy machine 100, in one embodiment, is responsible for requesting that water treatment device 10 change states, such as from "sleep" to "treatment". In the "sleep" state, water treatment device 10 is maintained at a minimum power usage state. In the "treatment" state, water treatment device 10 is at a fully functional power level. As discussed above, the systems and methods of the present invention contemplate many ways of coupling water treatment device 10 to home therapy machine 100 upon a request for water from home therapy machine 100. In each alternative, water treatment device 10 provides water suitable for treatment to home therapy machine 100 at an appropriate volume or flow rate.

[0087] Water treatment device 10 can send information to be displayed on user interface 122 to prompt necessary user action. Water treatment device 10 can send status information to home therapy machine 100 asynchronously or in response to a status query. Water treatment device 10 can also send error packets to home therapy machine 100 in case of errors or alarms. Home therapy machine 100 can determine what action needs to be taken and whether to notify user 12 via user interface 122. If user 12 needs to provide any input to clear the alarm, he can do so via user interface 122. Water treatment device 10 is responsible for informing home therapy machine 100 about the current state of the device. Water treatment device 10 is also responsible for informing home therapy machine 100 about any alarms or warnings.

[0088] When water is required for treatment, the home therapy machine 100 of one embodiment described above specifies a desired water flow rate to the water treatment device 10. The water treatment device 10 then provides water at the desired flow rate. Alternatively, as described above, the water treatment device 10 calculates or looks up the flow rate based on a treatment liquid flow rate transmitted from the home therapy machine 100. Alternatively, as described above, the water treatment device 10 determines the flow rate from its own device prescription. Additionally, as described above, the water treatment device 10 and the home therapy machine 100 can also work together on a volumetric basis.

[0089] It will be appreciated that using and controlling both water treatment device 10 and home therapy machine 100 from user interface 122 increases safety, minimizes the complexity of operating multiple devices, and eases the burden of treating patients at home. Additionally, the functionality of water treatment device 10 and home therapy machine 100 is streamlined through the master/delegate processor configuration.

Installation of water treatment equipment
[0090] System 110 contemplates that water treatment device 10 and home therapy machine 100 may work together in many different ways, often with a common user interface 122. Referring now to Figure 4, for example, process 400 is an exemplary process for installing or initializing water treatment device 10 using user interface 122 of home therapy machine 100. Upon beginning process 400 at a start block, user 12 connects water treatment device 10 to home therapy machine 100 as shown in block 402, for example establishing data connection means 32 and water line connection 34 as described above. Once user interface 122 detects the data connection, user 12 will ask whether user 12 would like guidance with installing water treatment device 10, as shown in block 404. If user 12 selects "no", the process ends at an end block adjacent to block 404. If the user 12 selects “Yes”, the user interface 122 prompts the user 12 to first place the RO cartridge and press “Confirm” on the user interface 122 , as shown in block 406 .

[0091] When the user 12 presses "Confirm," the home therapy machine 100 queries the water treatment device 10 as to whether an RO cartridge is detected and properly installed, as shown in block 408. If an RO cartridge is not detected or properly installed, the water treatment device 10 reports an error condition, as shown in block 410, and displays an error message on the user interface 122, as shown in block 411. If an RO cartridge is detected and properly installed, the water treatment device 10 responds in the user interface 122 that an RO cartridge is present, as shown in block 412, and sends the cartridge information to the home therapy machine 100.

[0092] Next, the user interface 122 displays to the user 12, "Install the pretreatment cartridge and press 'Confirm'", as shown in block 414. Once the user 12 installs the cartridge and presses 'Confirm' on the user interface 122, the home therapy machine 100 queries the water treatment device 10 as to whether a pretreatment cartridge is present, as shown in block 416. If the pretreatment cartridge is not present or there is an error, the water treatment device 10 responds with a pretreatment cartridge error, as shown in block 418. In this case, the user interface 122 displays a message to the user 12 that the pretreatment cartridge is not properly installed, as shown in block 420. If the pretreatment cartridge is present, the water treatment device 10 responds that a pretreatment cartridge is present, as shown in block 422, and sends the cartridge information to the home therapy machine 100.

[0093] Next, as shown in block 424, the user interface 122 displays a message to the user 12 requesting that the water treatment device 10 be connected to provide water, turn on the water supply, and press "CHECK". Once the user 12 presses "CHECK", the home therapy machine 100 queries the water treatment device 10 as to whether the water supply is connected and/or whether the water supply pressure is acceptable, as shown in block 426.

[0094] Next, the user interface 122 prompts the user 12 to "Place the drain line in the drain and ensure there is an air gap," as shown in block 428. Once the user 12 confirms these steps, the user interface 122 displays a message to the user 12 informing the user 12 that the water treatment device 10 will begin cleaning, and that cleaning may take several hours, as shown in block 430. The user interface 122 also displays a "CLEAN" button. Once the user 12 presses the "CLEAN" button, the water treatment device 10 begins cleaning, as shown in block 432. Thus, it is not necessary to provide a separate "CLEAN" button on the water treatment device 10, although one may be provided for redundancy. In either case, the water treatment device 10 changes the device state to "CLEAN" and notifies the home therapy machine 100 of this state change, as shown in block 434. The user interface 122 displays "CLEANING. Press STOP to pause the cleaning process," as shown in block 436, and displays the "Stop" or "Pause" button accordingly. The water treatment device 10 also reports the status of the valves and pumps, as well as the system mode of the entire device, as shown in block 438. Once cleaning is complete, the user interface 122 indicates that cleaning is complete, as shown in block 440. The status changes are also reported to the home therapy machine 100, as shown in block 442. The process 400 then ends, as shown in the end block.

[0095] It should be understood that the above steps of process 400 include individual functions performed by water treatment device 10, but the display of instructions and user inputs occurs on user interface 122. Thus, user 12 can focus solely on user interface 122 to set up water treatment device 10 and perform treatments on home therapy machine 100.

Water Generation
5 illustrates an exemplary process 500 for generating water with the water treatment device 10 using the user interface 122 of the home therapy machine 100. Upon beginning the process 500 at a start block, the home therapy machine 100 activates or "wakes up" and commands the water treatment device 10 to generate water at a specified flow rate (or until the dialysate in the dialysate holding tank reaches a specified volume), as shown in block 502. In one embodiment, the water treatment device 10 performs necessary functions before generating water. Once activated or woken up, the home therapy machine 100 performs start-up activities such as self-tests, cleaning and safety checks. Once the water treatment device 10 completes the required activities, at block 506, it "wakes up" and is ready to generate water. The home therapy machine 10 continually queries the status of the water treatment device 10 and displays this status on the user interface 122, as shown in block 508. When water treatment device 10 completes start-up and is ready to produce purified water, as indicated in block 510, if home therapy machine 100 is in use, water treatment device 10 will wait for home therapy machine 100 to draw water, as indicated in block 512. Once home therapy machine 100 is ready, home therapy machine 100 will begin drawing water, as indicated in block 514. User interface 122 will indicate to user 12 that home therapy machine 100 is drawing water from water treatment device 10, as indicated in block 516.

[0097] The user interface 122 may provide an option for the user 12 to change the water preparation flow rate of the water treatment device 10 or to pause or stop the production of water. Alternatively, as described above, the home therapy machine 100 may instruct the water treatment device 10 to change the flow rate based on instructions stored in the ACPU 112. In one embodiment, the water treatment device 10 is configured to change the recovery rate based on demand. The RO unit of the water treatment device 10 produces wastewater. The wastewater can be recovered and sent back to the RO unit to reduce the amount of water actually rejected and discharged, but doing so may shorten the useful life of the RO unit since sending recycled wastewater to the RO unit may cause fouling. However, if the home therapy machine 100 is not using all of the available flow of purified water produced by the water treatment device 10, the wastewater flow from the RO unit may be mixed with excess purified water to produce a solution that is functionally equivalent to tap water and does not cause excessive fouling of the RO unit. In this way, the water treatment device 10 can adjust the amount of waste RO water recycled based on the availability of unused purified water that can be mixed with the waste stream before re-entering the RO unit.

[0098] Once the home therapy machine 100 has finished drawing water, the home therapy machine 100 commands the water treatment device 10 to go to sleep, as shown in block 518. In the sleep state, the water treatment device 10 continues to communicate with the home therapy machine 100 and waits for another wake-up command. In the sleep state, the water treatment device 10 may also periodically flush the flow path after every set stagnation period to maintain device performance even without a wake-up command. The water treatment device 10 changes the device state to sleep, as shown in block 520, and sends the state to the home therapy machine 100 for display to the user 12. The process 500 then ends, as shown in the end block.

Start-up of home therapy machines and water treatment equipment
6 illustrates an exemplary process 600 for starting up home therapy machine 100 and water treatment device 10 using user interface 122 of home therapy machine 100. Upon beginning process 600 at a start block, user interface 122 prompts user 12 to perform start-up tests on water treatment device 10, as shown in block 602. For example, user interface 122 may request user 12 to verify and run self-tests on UV intensity, RO defect rate, and total organic carbon (TOC) levels, each associated with water treatment device 10. Other self-tests associated with water treatment device 10 may include, for example, whether remaining pre-treatment cartridge life is sufficient, etc.

[00100] Self-tests for the water treatment device 10 include a chlorine/chloramine test. For example, the ACPU 112 may determine that a chlorine/chloramine test should be performed. The user interface 122 may prompt the user to collect a water sample for testing from the water treatment device 10, if desired, by pressing a button on the user interface 122. The chlorine/chloramine test is performed, as shown in block 603, and the user interface 122 may display result options for the chlorine/chloramine test (e.g., pass or fail) to the user and prompt the user for a response, as shown in block 606. Depending on the results of the chlorine/chloramine test, the process 600 may complete other self-tests for the device 10, return to self-tests for the home therapy machine 100, or proceed to another task for the water treatment device 10.

[00101] Thus, process 600 may alternate between steps 602 and 603, as indicated by the double-headed arrow between steps 602 and 603. For example, if water treatment device 10 fails the chlorine/chloramine test, home treatment machine 100 may signal water treatment device 10 that a pretreatment swap is required or that the sample needs to be retested to confirm the fault. Water treatment device 10 changes its system state to "cartridge swap" and communicates this state change to ACPU 112. User interface 122 indicates to user 12 that water treatment device 10 requires a pretreatment cartridge swap. User interface 122 then prompts user 12 to take steps to swap the pretreatment cartridge. Any errors in water treatment device 10 are displayed to user 12 via user interface 122. Alternatively, user interface 122 may prompt the user for a response, as indicated in block 606. Once the pre-treatment cartridge swap step is complete, the water treatment device 10 changes the device status and sends the status to the home therapy machine 100 for display to the user 12.

[00102] If all self-tests associated with the water treatment devices 10 provide positive results without errors, the user interface 122 proceeds to perform self-tests of the home therapy machine 100, as shown in block 604. Alternatively, the ACPU 112 may alternate between self-tests of the home therapy machine 100 and self-tests of the water treatment devices 10. In other words, as described above, it may not be desirable to first perform self-tests of all home therapy machines 100 and then self-tests of the water treatment devices 10, or vice versa. The self-tests may be performed alternately or simultaneously. Thus, the process 600 may alternate between steps 602, 603, and 604, as shown by the double-headed arrows between steps 602 and 603 and between steps 602 and 604. As shown in block 606, at any time, the home therapy machine 100 or water treatment device 10 self-tests may display results to the user 12 on the user interface 122 or prompt the user 12 for a response. This alternating between tests may improve efficiency and save time while allowing the user 12 to focus their attention on one user interface 122.

[00103] Process 600 ends as shown in the end block, but may end later from either step 602, 603 or 604, depending on the results of the self-tests and the order of alternating performance of the self-tests.

Performing a pretreatment cartridge/membrane swap
[00104] Figure 7 illustrates an exemplary process 700 for performing a pretreatment cartridge swap of the water treatment device 10 using the user interface 122 of the home therapy machine 100. The process 700 begins at a start block, where the water treatment device 10 checks whether the pretreatment cartridge is fully depleted, as shown in block 702. If the pretreatment cartridge is not fully depleted but will soon need to be replaced, the water treatment device 10 transmits an alert to the home therapy machine 100 via the data connection means 32, as shown in block 704. The user interface 122 indicates that the pretreatment cartridge will soon need to be replaced, as shown in block 706, and in one embodiment presents the user 12 with an option and selection button as to whether the user 12 would like to replace the pretreatment cartridge now or later. If the user selects to replace the pretreatment cartridge later via the user interface 122, the process 700 ends, as shown in an end block. If the user selects to replace the pretreatment cartridge now via the user interface 122, the process 700 proceeds to step 712, described below.

[00105] If the pretreatment cartridge is completely degraded and the water treatment device 10 cannot produce water unless it is immediately replaced, as shown in block 708, the water treatment device 10 transmits an alert to the home therapy machine 100 via the data connection means 32, and causes the user interface 122 to display to the user 12 that the pretreatment cartridge must be immediately replaced, as shown in block 710.

[00106] If the user 12 selects in the user interface 122 to replace the pretreatment cartridge now (if the pretreatment cartridge is not needed) or if the pretreatment cartridge must be replaced immediately, the user interface 122, in one embodiment, guides the user 12 through the process of replacing the pretreatment cartridge, as shown in block 712. Instructions for the user task are displayed in the user interface 122. Once the pretreatment cartridge swap is complete, as shown in block 714, the water treatment device 10 changes the device state, and the change is displayed to the user 12 via the user interface 122, as shown in block 716. In various embodiments, the process 700 can be used alternatively or additionally to perform an RO membrane swap. The process 700 then ends, as shown in the end block.

Setting and utilizing supplies and treatment regimens
[00107] Medical products and medications are transported or delivered to the patient's home for use by the home therapy machine 100 during treatment. Typically, only therapy products or medications authorized by a physician's prescription may be transported to the patient's home. In the United States, such prescriptions typically last for one year, and patients may have multiple prescriptions available at any given time to dynamically manage their condition. The system hub 120 stores one or more prescriptions for each patient. Each home therapy machine 100 uses supplies and settings according to this prescription. When a patient's prescription is changed or a prescription is added, the patient's clinician uses the web portal 150 to update the settings of the home therapy machine 100 to change or add the prescription. When the settings of the home therapy machine 100 are updated, the system hub 120 sends the updated settings to the home therapy machine 100 via the connectivity service as described above. For example, in one embodiment, the home therapy machine 100 communicates with the system hub 120 only when the connectivity agent 114 is turned on.

[00108] Referring now to FIG. 8, process 800 illustrates an exemplary process for shipping inventory and programming a prescription for the home therapy machine 100 based on a physician's prescription for a particular patient. That is, a physician associated with a clinic 152a-152n may access the system hub 120 via the web portal 150 to deliver the patient's treatment prescription (used for both supplies and machine operation) to the clinician. Once process 800 begins at a start block, the clinician retrieves the electronic prescription prescribed by the physician using the web portal 150, as shown in block 802. In the web portal 150, the clinician selects a dialyzer, blood circuit set, acid, bicarbonate, needles, etc., and any other supplies needed to fill the prescription and perform on the home therapy machine 100, including possibly supplies for the water treatment device 10. As shown in block 804, the selected dialyzer and other supplies are shipped to the patient's home.

[00109] At the same time, or at a later time, the clinician can remotely access the system hub 120 via the web portal 150 to program the prescription for the home therapy machine 100, as shown in block 806. The system hub 120, in one embodiment, holds the treatment prescription until the connectivity agent 114 of the home therapy machine 100 is turned on, as shown in blocks 820-824.

[00110] The clinician sets the various treatment parameters used to program the prescription for the home therapy machine 100, such as blood flow rate, dialysate flow rate, UF volume, and heparin flow rate flush, as shown in block 808. In one embodiment, the settings specified by the clinician may include settings for operating the water treatment device 10 or affect the parameters of the water treatment device 10 as described above, so that separate setting of the parameters of the water treatment device 10 is not necessary. Alternatively, the clinician may separately set the various treatment parameters used to program the prescription for the water treatment device 10, as shown in block 810.

[00111] The clinician also specifies the tolerance ranges for various settings, as shown in block 812. That is, the patient is allowed to choose values for certain parameters within a certain range of values under the specified treatment prescription. In this way, the patient has a certain amount of control over the treatment being performed. For example, the temperature of the dialysate can be set within a range of acceptable values based on the patient's preferences and comfort. The clinician also specifies whether the patient can modify the settings at all, as shown in block 814. If the patient is allowed to modify the parameter settings, the variability of the settings is allowed to be within an acceptable range so that the patient can choose values within the range specified by the clinician in block 812. The clinician then submits the settings to the system hub 120, as shown in block 816.

[00112] The system hub 120 then transmits the treatment prescription to the connectivity server 118, as shown in block 818. The next time the connectivity agent 114 on the home therapy machine 100 is turned on or becomes operational, as shown in block 820, the home therapy machine 100 checks the connectivity server 118 for a treatment prescription, as shown in block 822. If a treatment prescription for the home therapy machine 100 is on the connectivity server 118, the connectivity server 118 transmits the treatment prescription to the home therapy machine 100, as shown in block 824. The machine 100 prompts the patient to accept the treatment prescription. In one embodiment, the patient must accept the treatment prescription and continue using the home therapy machine 100, as shown in block 826.

[00113] In one embodiment, the treatment prescription downloaded from the connectivity server 118 may be a new or updated prescription to replace a previous treatment prescription already on the machine 100. Before starting treatment, e.g., after sterilization the previous day, the ACPU 112 of the home therapy machine 100 checks whether the connectivity service via the agent 114 has published an updated treatment prescription for that particular home therapy machine 100. To do this, in one embodiment, the home therapy machine 100 and the system hub 120, via the connectivity service, compare prescription version numbers to determine whether the home therapy machine 100 has the last updated prescription. If not, the last version of the prescription is delivered to the therapy machine 100. The machine 100 will not execute the old treatment prescription if a new treatment prescription is downloaded from the connectivity server 118 and present on the machine 100. However, the new treatment prescription will not overwrite the old treatment prescription until the patient accepts the treatment prescription as shown in block 826. In this way, the patient is assured that they are aware of the changes to their treatment. Upon receiving a new treatment prescription, the new treatment prescription is written to the memory of the treatment machine 100. In an alternative embodiment, the machine 100 may store multiple treatment prescriptions in memory so that old treatment prescriptions are retained in memory even as new treatment prescriptions are downloaded. The machine 100 may also be capable of storing various types or categories of treatment prescriptions. Each different type of treatment prescription may provide a different treatment, such as removing a low, medium, or high amount of ultrafiltrate for dialysis. The machine 100 may also be capable of storing one treatment prescription for each category.

[00114] The ACPU 112 receives the settings, separates the settings of the home therapy machine 100 from the settings of the water treatment device 10, and transmits the settings of the water treatment device 10 to the water treatment device 10 via the data connection means 32, as shown in block 827. The settings can be flagged as being for the home therapy machine or for the water treatment device 10. Alternatively, the ACPU 112 can recognize features in the settings as being specific to the water treatment device 10 and pass those settings to the water treatment device 10. The next time the patient attempts to perform a treatment, the connectivity agent 114 is turned off, as shown in block 828. The home therapy machine 100 performs the treatment using the treatment prescription specified in blocks 808 and/or 810, as shown in block 830. The home therapy machine 100 writes treatment data resulting from the treatment to a log file, as shown in block 832. Again, the log file documents the relevant home therapy machine 100 data and the relevant water treatment device 10 data during the treatment. In one embodiment, water treatment device 10 transmits its own log file to home therapy machine 100. Home therapy machine 100 loads the data from water treatment device 10 into its log file. The next time connectivity agent 114 is turned on, the combined log file stored on home therapy machine 100 is transmitted to connectivity server 118.

[00115] The connectivity agent 114 is turned on, as shown in block 834. In one embodiment, the home therapy machine 100 initiates a connection to the connectivity service. In an alternative embodiment, the connectivity service may initiate a connection to the home therapy machine 100. At block 836, the log file is uploaded to the connectivity server 118. The process 800 then ends, as shown in the end block.

[00116] In one embodiment, the machine 100 may perform a post-treatment procedure, such as a sterilization procedure to clean the machine and disposables used in the treatment in preparation for the next treatment. In one embodiment, the system 110 may turn on the connectivity agent at block 834 after the treatment, but while the post-treatment sterilization is occurring. Writing the treatment data at block 832 may also occur during sterilization. Alternatively, the home therapy machine 100 waits to write at block 832 or turn on the connectivity agent at block 834 until sterilization is complete and the machine 100 is in an idle mode.

[00117] In the illustrated embodiment, the connectivity agent 114 is turned off before treatment and is not turned on again until after treatment, so the system 110 does not provide real-time monitoring of the treatment. Events that occur during treatment, such as alarms and warnings, are not immediately reported to the system hub 120. Such information is included in a log file that is sent to the system hub 120 after treatment. In an alternative embodiment, the connectivity agent 114 can remain on during treatment and can report information about the home therapy machine 100 and the treatment in real time.

Firmware Upgrade
[00118] From time to time, it may be necessary to upgrade the software, sometimes referred to herein as firmware, that the ACPU 112 executes on the home therapy machine 100 and/or the software that executes on the processor/memory 24 of the water treatment device 10. The home medical device system 110 provides an efficient and reliable method of upgrading firmware, including by a product development team 128 and service personnel 132a-132n (FIG. 1A).

[00119] FIG. 9 illustrates an exemplary process 900 for upgrading firmware for a home therapy machine 100. Process 900 begins at a start block, where a product development team 128 develops a firmware upgrade for the home therapy machine or water treatment device 10, as shown in block 902. At block 904, product development team 128 uploads the firmware upgrade to system hub 120. Service portal 130 then allows a service personnel supervisor or decision maker 134 to view and approve the upgrade. Once the upgrade is approved, supervisor 134 uploads the upgrade from system hub 120 to connectivity server 118, as shown in block 906. In the embodiment illustrated in FIG. 1A, supervisor 134 is a separate person from service personnel 132a-132n, who are responsible for servicing and maintaining home therapy machine 100 and water treatment device 10, as well as for engaging with patients. The service personnel supervisor 134 not only has the authority to make the final decision on whether to send the upgrade to the connectivity server 118, but can also specify which, if not all, machines 100 and/or water treatment devices 10 receive the upgrade, and can also reject the upgrade or return it to the product development team 128 for refinement. Once the upgrade is allowed to reach the connectivity server 118, the service personnel 132a-132n, or a designated one therein, can view the firmware upgrade via the service portal 130, as shown in block 908. In one embodiment, the product development team 128 uploads the firmware upgrade directly to the connectivity server 118 without going through the system hub 120.

1A, the service personnel 132a-132n manage the day-to-day relationship with the patient. The service personnel 132a-132n are familiar with the patient's schedule and are in the best position to determine when the patient should receive a firmware upgrade. For example, the service personnel 132a-132n know the maintenance and operation schedules for the home therapy machine 100 and corresponding water treatment device 10 that they typically service. If the patient's machine 100 and/or water treatment device 10 is soon scheduled to receive a part required for a firmware upgrade, the service personnel 132a-132n can wait until the new part is installed and then upgrade the firmware (e.g., as may require the new part) of the patient's home therapy machine 100 and/or water treatment device 10.

[00121] Each service representative 132a-132n selects which of the designated home therapy machines 100 and/or water treatment devices 10 should receive the firmware upgrade, as shown in block 910. The next time the connectivity agents 114 of the selected home therapy machines 100 are turned on, as shown in block 912, the connectivity server 118 that was waiting for those agents to turn on will send the upgrade to the selected home therapy machines 100 and/or water treatment devices 10, as shown in block 914.

[00122] In one embodiment, the selected home therapy machine 100 and/or water treatment device 10 may determine whether to accept the upgrade based on settings stored in the ACPU 112 and/or processor/memory 24, as shown in block 916. If the selected home therapy machine 100 and/or water treatment device 10 chooses not to upgrade, the process 900 ends, as shown in block 916 and an end block. If any of the selected home therapy machines 100 and/or water treatment devices 10 accept the upgrade, the corresponding patient is asked via the user interface 122 whether they would like to install the upgrade, as shown in block 918. If the patient does not choose to upgrade the selected home therapy machine 100 and/or water treatment device 10 via the user interface 122, the process 900 ends, as shown in block 920 and an end block. If the patient chooses to upgrade(s) the selected home therapy machine 100 and/or water treatment device 10 via the user interface 122, the upgrade(s) are performed, as shown in block 922, and the home therapy machine 100 notifies the patient via the user interface 122 that the software has been upgraded. In some countries, laws require that patient approval be obtained before upgrading the patient's firmware. In one embodiment, the system 110 may provide that only home therapy machines 100 in countries that require patient approval need to prompt the patient to accept the firmware upgrade at blocks 918 and 920.

[00123] The home therapy machine 100 may retain the ability to revert to a previous software version of either the machine 100 or the device 10, or both. For example, if a firmware upgrade becomes corrupted, or if the firmware of the home therapy machine 100 or water treatment device 10 becomes corrupted, in one embodiment the home therapy machine 100 may revert to a previous, uncorrupted software version. Alternatively, the home therapy machine 100 may not be able to revert to a previous software version. Here, if the software is corrupted or becomes corrupted, new software is installed or the home therapy machine 100 or water treatment device 10 is replaced with a new home therapy machine 100 or water treatment device 10.

[00124] The connectivity service in server 118 documents all events related to the firmware upgrade, such as which patients received the upgrade and which service personnel 132a-132n were involved in the upgrade. The connectivity server 118 stores serial numbers, tracking numbers and software versions so that the various steps of the upgrade process are documented and the current software version of each machine 100 and device 10 in the system 110 at any given moment can be easily obtained. At the end block of FIG. 9, the process 900 ends.

[00125] As mentioned above, any software updates for water treatment device 10 can also be sent to water treatment device 10 via home therapy machine 100. Home therapy machine 100 can receive a combined software upgrade that includes software upgrades for both home therapy machine 100 and water treatment device 10. Alternatively, the upgrades can be delivered separately. ACPU 112 then parses and separates the software content of home therapy machine 100 from the software content of water treatment device 10. In particular, ACPU 112 can recognize which software content is intended for home therapy machine 100 and which software content is intended for water treatment device 10. For example, the software content can appear to be or include content that is inherently specific to either home therapy machine 100 or water treatment device 10. Alternatively, the software content can be flagged as intended for home therapy machine 100 or water treatment device 10. The home therapy machine 100 then transmits software content for the water treatment device 10 to the water treatment device 10 via the data connection means 32.

[00126] Firmware upgrades may also be provided in the manner described above for other home components of the system 110, such as the tablet 122, the blood pressure monitor 104, and/or the scale 106.

Clinician dashboard with rules evaluation
[00127] A clinician can view a list of his/her patients and a file for each patient showing how the patient's treatment went. The treatment file is derived from the home therapy machine 100 log file, such as actual flow rate achieved, ultrafiltrate removal, actual ultrafiltration rate achieved, blood pressure during treatment, weight, etc. The log file may also include water treatment device 10 treatment data as described above. Stored water treatment device 10 treatment data may include, for example, total purified water volume delivered, average water temperature, average water pressure, number of delivery requests from machine 100, warning and alarm information, chlorine/chloramine levels, and/or component usage or replacement information.

[00128] The clinician can sort the list of patients by a number of categories, such as the type of treatment the patient received, e.g., hemodialysis (e.g., subdivided into short daily, overnight, alternate daytime, alternate nighttime, etc.), peritoneal dialysis (e.g., subdivided into continuous cycling peritoneal dialysis (CCPD), tidal, etc.), the responsible physician, or notifications, as described below. The clinician can also view a photo of the patient and a summary for a weekly, monthly, or other time period.

[00129] The web portal 150 provides a clinician dashboard with notifications for events that occur during a procedure. In one embodiment, these notifications include color-coded flags, with individual colors corresponding to different notification states. The clinician can select which events generate red or yellow flags that are visible on the dashboard. In one embodiment, the flagging is per clinic, not per patient. Thus, when a clinician chooses to be notified about a particular event, it applies to all patients in that clinic, or all patients cared for by that clinician. For example, the clinician can set a rule that if the procedure duration was less than four hours, a yellow flag will appear on the dashboard. This rule will apply to all patients in that clinic, or all patients cared for by that clinician. The dashboard will indicate, for example, with a yellow flag, all patients who had a procedure that lasted less than four hours. These flags may also be relevant to the water treatment device 10, for example, posting a flag when the useful life of a disposable component of the water treatment device 10 is less than 10 hours, or posting a red flag when the chlorine/chloramines tested reach a certain level.

[00130] FIG. 10A illustrates an exemplary dashboard screen 1000 for a clinic shown on a clinician's display device 192. The dashboard screen 1000, in one embodiment, is the first screen a clinician sees when logging into the web portal 150. The dashboard screen 1000 provides an overview of the patients being treated at the clinic and how treatments are being performed by the home therapy machine 100 and water treatment device 10.

[00131] Patients are listed by name, as shown in column 1002. Dashboard 1000 may allow the clinician to apply filters, as shown in drop-down menu 1010. For example, in the illustrated embodiment, the clinician may filter the dashboard information by patient type (not shown), physician in drop-down menu 1012, or patient condition (not shown). The clinician may also filter the dashboard information to show only procedures for which there was no communication using checkbox 1014, or to show only procedures for which a flag was generated using checkbox 1016. These filters allow the clinician to focus attention on specific desired information.

[00132] Various icons 1004, 1006, and 1008 indicate information about procedures performed by the patient on a particular day. Icons 1004, 1006, and 1008 may indicate different types of events. For example, icon 1004 may be used to indicate that a procedure performed by home therapy machine 100 and water treatment device 10 was successful. Icon 1006 may be used to notify a clinician about an event that is not critical and does not require immediate attention, but should be closely monitored in the future. For example, icon 1008 may be used to notify a clinician about an event that requires immediate attention.

[00133] A user can access the explanatory text using link 1018. When the user selects link 1018, a pop-up window or new screen 1050 appears. FIG. 10B illustrates an exemplary explanatory screen 1050 that explains various icons that may appear on the dashboard screen 1000 as displayed on the clinician's display device 192. Icon 1004 indicates that the result of the treatment performed by the home therapy machine 100 and water treatment device 10 was "OK". Icon 1008 indicates a high priority flag. Icon 1006 indicates a normal priority flag. Icon 1010 indicates that there has been no communication with the home therapy machine 100 associated with the patient for the particular treatment.

[00134] In one embodiment, the dashboard also displays information collected by the water treatment device 10 in the water treatment device 10's log file. FIG. 11A illustrates an exemplary treatment summary screen 1100 shown on the clinician's display device 192 that is part of the clinician's dashboard or accessible via a link from the dashboard. Treatment summary screen 1100 provides details about specific treatments performed on the patient by the home therapy machine 100 and water treatment device 10, as collected in the log file as described above. FIG. 11A shows information about treatments performed by the home therapy machine 100 and water treatment device 10 on July 31, 2010, as shown in chart 1102. From treatment summary screen 1100, the clinician can view an explanation of the flag symbols in chart 1101. The clinician can also view the date, start time and total dialysis time in chart 1102, the prescribed device program in chart 1104, and an overall treatment summary log in chart 1106 in table format showing the exact times of various treatment events for the home therapy machine 100 and/or the water treatment device 10. The treatment summary screen 1100 also shows information collected from the water treatment device 10. For example, item 1107 in chart 1106 shows the clinician that the water treatment device 10 indicated a cold water warning at time 20:41:13. Any warnings or events documented in the log file and displayed on the clinician dashboard can also be communicated to the user 12 via the user interface 122 when the warning or event occurs during the treatment.

[00135] The screen 1100 displayed on the clinician's display 192 continues in FIG. 11B. As shown in FIG. 11B, the clinician can view fluid management details in chart 1108, treatment dosage information in chart 1110, heparin details in chart 1112, dialyzer extended use data in chart 1114, blood pressure in chart 1116, and pulse details in chart 1118. The clinician can also view information about pretreatment samples taken for comparison in chart 1120, such as the time 1121 when the water sample was taken from the water treatment device 10. The clinician can also view details about the device program of the prescription in chart 1122. The clinician can also view the device ID of the home therapy machine 100 and the software versions of the home therapy machine 100 and the water treatment device 10 in chart 1124.

[00136] FIG. 12 illustrates an exemplary patient usage report 1200 that may be presented to a clinician in the web portal 150 on the clinician's display device 192. The exemplary patient usage report 1200 allows the clinician to view the amount of product or consumables used by the home therapy machine 100 and the water treatment device 10 for a particular patient's treatment within a specified time frame. In the patient usage report 1200, the clinician can view information regarding the treatment month 1202 and usage by the home therapy machine 100, such as the dialyzer 1204 used, the blood treatment set 1206 used, the acid concentrate 1208 used, and the bicarbonate concentrate 1210 used. The clinician can also view information regarding usage by the water treatment device 10, such as the water pre-filter 1212 used and the water distribution loop 1214 used. Thus, the clinician can view information regarding the usage of consumables for one or more treatments for the home therapy machine 100 and the water treatment device 10.

Additional Aspects of the Disclosure
[00137] Aspects of the subject matter described herein may be useful alone or in combination with any one or more of the other aspects described herein. Without limiting the foregoing, according to a first aspect of the present disclosure, a home medical device system includes a home therapy machine for providing home therapy to a patient, a user interface operatively connected to the home therapy machine for receiving operator input, a water treatment device in fluid communication with the home therapy machine, and a data connection between the home therapy machine and the water treatment device, the home therapy machine transmitting data to the water treatment device via the connection to control the water treatment device, the data being provided based on at least one of the operator inputs received via the user interface.

[00138] According to a second aspect of the present disclosure, which may be used in combination with any one or more of the preceding aspects, the water treatment device transmits at least one of (i) status information, (ii) component life information, (iii) self-test results, (iv) warning information, or (v) version information to the home therapy machine.

[00139] According to a third aspect of the present disclosure, which may be used in combination with any one or more of the preceding aspects, the user interface displays at least one of: (i) the status information, (ii) the component life information, (iii) the self-test results, (iv) the warning information, or (v) the version information.

[00140] According to a fourth aspect of the present disclosure, which may be used in combination with any one or more of the preceding aspects, the home therapy machine transmits at least one of the following to the water treatment device: (i) a state change request; (ii) a status inquiry; (iii) a flow rate change request; (iv) a software upgrade or downgrade; or (v) a file transfer.

[00141] According to a fifth aspect of the present disclosure, which may be used in combination with any one or more of the preceding aspects, the user interface displays at least one of: (i) the state change request; (ii) the status inquiry; (iii) the flow rate change request; (iv) the software upgrade or downgrade; or (v) the file transfer.

[00142] According to a sixth aspect of the present disclosure, which may be used in combination with any one or more of the preceding aspects, the at least one operator input leading to the transmitted data relates to a parameter of the water treatment device.

[00143] According to a seventh aspect of the present disclosure, which may be used in combination with any one or more of the preceding aspects, the at least one operator input leading to the transmitted data relates to a parameter of a home therapy machine, and the transmitted data relates to an automatically obtained result of changing the parameter of the home therapy machine.

[00144] According to an eighth aspect of the present disclosure, which may be used in combination with any one or more of the above aspects, a home treatment medical system includes a home treatment machine for performing a home treatment on a patient, a user interface operatively connected to the home treatment machine for receiving operator input, a water treatment device in fluid communication with the home treatment machine, a server in data flow communication with the home treatment machine, and a data connection device between the home treatment machine and the water treatment device, the home treatment machine transmitting data to the water treatment device via the connection, the data being based on a treatment prescription transmitted from the server to the home treatment machine.

[00145] According to a ninth aspect of the present disclosure, which may be used in combination with any one or more of the above aspects, the transmitted data is for controlling the water treatment device.

[00146] According to a tenth aspect of the present disclosure, which may be used in combination with any one or more of the preceding aspects, the treatment prescription specifies data to be transmitted from the home treatment machine to the water treatment device.

[00147] According to an eleventh aspect of the present disclosure, which may be used in combination with any one or more of the preceding aspects, the treatment prescription specifies operating parameters for the home treatment machine, and the transmitted data is based on the specified operating parameters.

[00148] According to a twelfth aspect of the present disclosure, which may be used in combination with any one or more of the preceding aspects, the home therapy machine determines the transmission data based on the specified operating parameters.

[00149] According to a thirteenth aspect of the present disclosure, which may be used in combination with any one or more of the preceding aspects, the water treatment device uses the data to determine corresponding operating parameters of the water treatment device.

[00150] According to a fourteenth aspect of the present disclosure, which may be used in combination with any one or more of the preceding aspects, the server is configured to transmit a software upgrade to the home therapy machine, and if the software upgrade is intended for the water treatment device, the software upgrade is forwarded by the home therapy machine to the water treatment device.

[00151] According to a fifteenth aspect of the present disclosure, which may be used in combination with any one or more of the preceding aspects, the software upgrade is installed on the water treatment device automatically or when accepted by a user via the user interface.

[00152] According to a sixteenth aspect of the present disclosure, which may be used in combination with any one or more of the above aspects, the server is in data communication with a service computer, and the service computer enables service personnel to access the water treatment device via the data connection device with the home therapy machine to perform at least one service procedure.

[00153] According to a seventeenth aspect of the present disclosure, which may be used in combination with any one or more of the aforementioned aspects, upon start-up, the home therapy machine is configured to determine whether the water treatment device is in a sleep mode, and if so, to perform a start-up procedure that does not include the water treatment device.

[00154] According to an eighteenth aspect of the present disclosure, which may be used in combination with any one or more of the aforementioned aspects, the home therapy medical system is configured to allow a user to perform at least one self-test of the home therapy machine and at least one self-test of the water treatment device via the user interface.

[00155] According to a nineteenth aspect of the present disclosure, which may be used in combination with any one or more of the aforementioned aspects, a home treatment medical system includes a home treatment machine for performing home treatment on a patient, a user interface operably connected to the home treatment machine for receiving operator input, a water treatment device in fluid communication with the home treatment machine, a server in data flow communication with the home treatment machine, and a data connection device between the home treatment machine and the water treatment device, the water treatment device configured to transmit data to the home treatment machine via the data connection device, and the home treatment machine forwards the data to the server.

[00156] According to a twentieth aspect of the present disclosure, which may be used in combination with any one or more of the preceding aspects, the transmitted data includes treatment log data.

[00157] According to a twenty-first aspect of the present disclosure, which may be used in combination with any one or more of the preceding aspects, the transmission data includes component usage data or component exchange data.

[00158] According to a twenty-second aspect of the present disclosure, any of the structures and functions shown and described in connection with FIG. 1 may be used in combination with any one or more of the preceding aspects.

[00159] According to a twenty-third aspect of the present disclosure, any of the structures and functions shown and described in connection with FIG. 1A may be used in combination with any one or more of the preceding aspects.

[00160] According to a twenty-fourth aspect of the present disclosure, any of the structures and functions shown and described in relation to FIG. 2 may be used in combination with any one or more of the preceding aspects.

[00161] According to a twenty-fifth aspect of the present disclosure, any of the structures and functions shown and described in relation to FIG. 3 may be used in combination with any one or more of the preceding aspects.

[00162] According to a twenty-sixth aspect of the present disclosure, any of the structures and functions shown and described in relation to FIG. 4 may be used in combination with any one or more of the preceding aspects.

[00163] According to a twenty-seventh aspect of the present disclosure, any of the structures and functions shown and described in relation to FIG. 5 may be used in combination with any one or more of the preceding aspects.

[00164] According to a twenty-eighth aspect of the present disclosure, any of the structures and functions shown and described in relation to FIG. 6 may be used in combination with any one or more of the preceding aspects.

[00165] According to a twenty-ninth aspect of the present disclosure, any of the structures and functions shown and described in relation to FIG. 7 may be used in combination with any one or more of the preceding aspects.

[00166] According to a thirtieth aspect of the present disclosure, any of the structures and functions shown and described in relation to FIG. 8 may be used in combination with any one or more of the preceding aspects.

[00167] According to a thirty-first aspect of the present disclosure, any of the structures and functions shown and described in relation to FIG. 9 may be used in combination with any one or more of the preceding aspects.

[00168] According to a thirty-second aspect of the present disclosure, any of the structures and functions shown and described in relation to FIG. 10A may be used in combination with any one or more of the preceding aspects.

[00169] According to a thirty-third aspect of the present disclosure, any of the structures and functions shown and described in relation to FIG. 10B may be used in combination with any one or more of the preceding aspects.

[00170] According to a thirty-fourth aspect of the present disclosure, any of the structures and functions shown and described in relation to FIG. 11A may be used in combination with any one or more of the preceding aspects.

[00171] According to a thirty-fifth aspect of the present disclosure, any of the structures and functions shown and described in relation to FIG. 11B may be used in combination with any one or more of the preceding aspects.

[00172] According to a thirty-sixth aspect of the present disclosure, any of the structures and functions shown and described in relation to FIG. 12 may be used in combination with any one or more of the preceding aspects.

[00173] It should be understood that various changes and modifications to the presently preferred embodiments described herein will be apparent to those skilled in the art. These changes and modifications can be made without departing from the spirit and scope of the inventive subject matter and without diminishing its intended advantages. Accordingly, these changes and modifications are intended to be covered by the appended claims.

[00174] Some other aspects of the invention are as follows.
1. A home treatment machine for providing home treatment to a patient;
a user interface operatively connected to the home therapy machine for receiving operator input;
a water treatment device in fluid communication with the home therapy machine;
a data connection device between the home therapy machine and the water treatment device;
A home medical device system comprising:
the home therapy machine transmits data to the water treatment device via the data connection device to control the water treatment device, the data being provided based on at least one of the operator inputs received via the user interface.
2. The home medical device system of claim 1, wherein the water treatment device transmits at least one of: (i) status information, (ii) component life information, (iii) self-test results, (iv) warning information, or (v) version information to the home therapy machine.
3. The home medical device system of claim 2, wherein the user interface displays at least one of: (i) the status information, (ii) the component life information, (iii) the self-test results, (iv) the warning information, or (v) the version information.
4. The home medical device system of claim 1, wherein the home therapy machine transmits at least one of the following to the water treatment device: (i) a status change request; (ii) a status inquiry; (iii) a flow rate change request; (iv) a software upgrade or downgrade; or (v) a file transfer.
5. The home medical device system of claim 4, wherein the user interface displays at least one of: (i) the state change request, (ii) the status inquiry, (iii) the flow rate change request, (iv) the software upgrade or downgrade, or (v) the file transfer.
6. The home medical device system of claim 1, wherein the at least one operator input leading to transmitted data relates to a parameter of a water treatment device.
7. The home medical device system of claim 1, wherein the at least one operator input leading to transmitted data relates to a parameter of a home therapy machine, and the transmitted data relates to an automatically obtained result of a change to a parameter of the home therapy machine.
8. A home therapy machine for providing home therapy to a patient;
a user interface operatively connected to the home therapy machine for receiving operator input;
a water treatment device in fluid communication with the home therapy machine;
a server in data flow communication with the home therapy machine;
a data connection device between the home therapy machine and the water treatment device;
A home medical device system comprising:
the home therapy machine transmits data to the water treatment device via the data connection device, the data being based on a treatment prescription transmitted from the server to the home therapy machine;
Home care medical system.
9. The home treatment medical system according to claim 8, wherein the transmitted data is for controlling the water treatment device.
10. The home therapy medical system of claim 8, wherein the treatment prescription specifies the data to be transmitted from the home therapy machine to the water treatment device.
11. The home therapy medical system of claim 8, wherein the treatment prescription specifies operating parameters for the home therapy machine, and the transmitted data is based on the specified operating parameters.
12. The home therapy medical system of claim 11, wherein the home therapy machine determines the transmission data based on the specified operating parameters.
13. The home therapy medical system of claim 11, wherein the water treatment device uses the data to determine corresponding operating parameters of the water treatment device.
14. The home therapy medical system of claim 8, wherein the server is configured to send a software upgrade to the home therapy machine, and if the software upgrade is intended for the water treatment device, it is forwarded by the home therapy machine to the water treatment device.
15. The home therapy medical system of claim 14, wherein the software upgrade is installed on the water treatment device automatically or when accepted by a user via the user interface.
16. The home therapy medical system of claim 8, wherein the server is in data communication with a service computer, the service computer enabling service personnel to access the water treatment device via the data connection to the home therapy machine to perform at least one service procedure.
17. The home therapy medical system of claim 8, wherein upon start-up, the home therapy machine is configured to determine whether the water treatment device is in a sleep mode, and if so, to perform a start-up procedure that does not include the water treatment device.
18. The home therapy medical system of claim 8, configured to allow a user to perform at least one self-test of said home therapy machine and at least one self-test of said water treatment device via said user interface.
19. A home therapy machine for providing home therapy to a patient;
a user interface operatively connected to the home therapy machine for receiving operator input;
a water treatment device in fluid communication with the home therapy machine;
a server in data flow communication with the home therapy machine;
a data connection device between the home therapy machine and the water treatment device;
A home medical treatment system comprising:
the water treatment device is configured to transmit data to the home therapy machine via the data connection device, the home therapy machine forwarding the data to the server;
Home care medical system.
20. The home therapy medical system of claim 19, wherein the transmitted data includes treatment log data.
21. The home therapy medical system of claim 19, wherein the transmitted data includes component usage data or component replacement data.

Claims (6)

a water treatment device including a water treatment processor and a water treatment memory;
a peritoneal dialysis (PD) machine having a PD processor and a PD memory, the PD machine including at least one mixing pump positioned and arranged to mix water treated by the water treatment device with at least one concentrate to generate a peritoneal dialysis fluid for treatment;
a wired or wireless data link between the water treatment processor and the PD processor;
Equipped with
(i) the PD memory and the PD processor cooperate to determine a flow rate of a first treated water and transmit the flow rate of the first treated water to the water treatment processor via the data link together with a start-up command; or (ii) the PD memory and the PD processor cooperate to calculate or find, via a look-up table, operating parameters including at least one of a dialysate flow rate and a pressure, temperature, or purity level of water present in the water treatment device and transmit the operating parameters to the water treatment processor via the data link together with the start-up command, and the water treatment processor and the water treatment memory cooperate to determine a flow rate of a second treated water from the operating parameters;
The water treatment processor and the water treatment memory cooperate to start up in response to the flow rate of the first treated water or the flow rate of the second treated water and the start-up command, and the water treatment device transports the treated water to the PD machine at the flow rate of the first treated water or the flow rate of the second treated water.
Peritoneal dialysis systems. The PD processor retrieves the flow rate of the first treated water from the PD memory of the PD machine.
The peritoneal dialysis system of claim 1 . The PD processor and the PD memory cooperate to determine a flow rate of the first treated water as a multiple of a flow rate of the dialysate.
The peritoneal dialysis system of claim 1 . The water treatment processor and the water treatment memory cooperate to determine a flow rate of the second treated water as a multiple of the operating parameter.
The peritoneal dialysis system of claim 1 . The PD processor and the PD memory cooperate to adjust a flow rate of the first treated water and a flow rate of the second treated water in the treatment.
The peritoneal dialysis system of claim 1 . A user interface is further provided,
Both the water treatment device and the PD machine are operated via the user interface.
The peritoneal dialysis system of claim 1 .

Images