FR3003174A1 - CONTROLLING A DEVICE FOR TREATING WATER THROUGH A DIALYSIS MACHINE USER INTERFACE - Google Patents

Abstract

A home medical device assembly includes a home therapy machine (100) for performing home therapy on a patient; a user interface (122) operably connected to the home therapy machine (100), the user interface (122) receiving operator inputs; a water treatment device (10) in fluid communication with the home therapy machine (100); and a digital link between the home therapy machine (100) and the water treatment device (10), wherein the home therapy machine (100) transmits data via the link to the therapy device (100). water treatment (10) for controlling the water treatment device, the data being delivered on the basis of at least one of the operator inputs received via the interface of the water treatment device user (122).

Description

The present invention relates generally to renal therapy devices and more particularly to devices and methods for controlling the therapy of the body. a water treatment device only or solely via a dialysis device. Due to illness, injury or other causes, a person's kidney system may fail. In kidney failure of any cause, there are several physiological disturbances. The balance of water, minerals and excretion of the daily metabolic load is no longer possible in case of kidney failure. During renal failure, toxic waste of nitrogen metabolism (urea, creatinine, uric acid, and others) can accumulate in the blood and tissues. Kidney failure and kidney failure were treated with dialysis. Dialysis removes waste, toxins and excess body water that would otherwise have been eliminated by the normal functioning of the kidneys. Dialysis treatment to ensure kidney function replacement is critical for many people because the treatment maintains life. A person whose kidneys are failing can not continue to live without replacing at least the kidney filtration functions.

Hemodialysis and peritoneal dialysis are two types of dialysis therapies commonly used to treat the loss of kidney function. The hemodialysis treatment uses the patient's blood to remove waste, toxins and excess water from the patient. The patient is connected to a hemodialysis machine and the patient's blood is pumped through the machine. Catheters or needles are inserted into the patient's circulatory system to deliver blood flow to and from the hemodialysis machine. The dialyzer may include a semipermeable membrane separating the blood from the dialysate. When the blood passes through a dialyzer in the hemodialysis machine (1), the dialyzer removes waste, toxins and excess water from the patient's blood. The hemodialysis machine returns the blood back to the patient. A large amount of dialysate, for example about one hundred and twenty liters, is used to dialyze the blood in a single hemodialysis treatment. The used dialysate is then discarded. The hemodialysis treatment lasts several hours and is generally carried out in a treatment center between three and four times a week. Peritoneal dialysis uses a dialysis solution or "dialysate", which is infused into the peritoneal cavity of a patient via a catheter implanted in the cavity. The dialysate contacts the peritoneal membrane of the patient in the peritoneal cavity. Waste, toxins and excess water pass from the patient's bloodstream through the peritoneal membrane and into the dialysate. The transfer of waste, toxins, and water from the blood stream into the dialysate occurs due to diffusion and osmosis, ie, an osmotic gradient that occurs through the membrane. The used dialysate is drained from the peritoneal cavity of the patient and removes waste, toxins and excess water from the patient. This cycle is repeated. There are different types of peritoneal dialysis therapy, including continuous ambulatory peritoneal dialysis ("DPAC"), automatic peritoneal dialysis, and continuous flow peritoneal dialysis. DPAC dialysis is a manual dialysis treatment in which the patient connects an implanted catheter to a drain and allows drainage of the used dialysate fluid from the peritoneal cavity. The patient then connects the catheter to a fresh dialysate bag and manually infuses the fresh dialysate through the catheter and into the peritoneal cavity of the patient. The patient disconnects the catheter from the fresh dialysate bag and allows the dialysate to remain inside the cavity to transfer waste, toxins and excess water from the patient's blood stream to the dialysate solution . After a period of stay, the patient repeats the manual dialysis procedure. In DPAC, the patient performs several cycles of drainage, filling, and stay during the day, for example, about four times a day. Each treatment cycle typically requires about one hour. Manual peritoneal dialysis performed by the patient requires a lot of time and effort from the patient. This inappropriate procedure leaves much room for improvement and therapy evolutions to improve the patient's quality of life. Automatic peritoneal dialysis ("APD") is similar to DPAC dialysis in that the dialysis treatment involves a drainage, filling, and residence cycle. However, DPA dialysis machines automatically perform three to four cycles of peritoneal dialysis treatment, typically during the night when the patient is sleeping. The DPA dialysis machines are fluidly connected to an implanted catheter. DPA dialysis machines are also fluidly connected to a fresh dialysate source or bag and a fluid drain. The DPA dialysis machines pump fresh dialysate from the dialysate source through the catheter into the peritoneal cavity of the patient and allow the dialysate to remain inside the cavity such that the transfer of the wastes toxins and excess water from the patient's blood stream to the dialysate solution can be assured. The DPA dialysis machines then pump the spent dialysate from the peritoneal cavity through the catheter to the drain. The DPA dialysis machines are typically computer controlled so that the dialysis treatment is provided automatically when the patient is connected to the dialysis machine, for example, when the patient sleeps. That is, the DPA dialysis systems automatically and sequentially pump the fluid into the peritoneal cavity, provide a residence period, pump the fluid out into the peritoneal cavity and repeat the procedure. As with the manual process, several cycles of drainage, filling, and stay are provided during dialysis DPA. A "last filling" is conventionally used in the end DPA dialysis, which remains in the peritoneal cavity of the patient when the patient is disconnected from the dialysis machine for the day. Dialysis DPA frees the patient from manually performing the drainage, filling, and residence steps.

For patients with kidney disease, frequent dialysis is a way to survive. Most patients on peritoneal dialysis dialysis once a day. Patients on hemodialysis should typically dialyze several times a week. To enable patients to continue to live their lives as normally as possible, there has been an increased desire to create home dialysis solutions. Peritoneal dialysis is conventionally performed at home. Hemodialysis and other blood treatment therapies, such as haemofiltration, are largely performed in medical and clinical centers. The implementation of dialysis, whether hemodialysis or peritoneal dialysis, at home represents more challenges and complexities for patients. Typically, dialysis is performed using a dialysis device and a fluid source. The source of fluid may be delivered in one or more prepared solution pouches or may be prepared directly by means of a water treatment device and concentrated additives. In the case of the water treatment device, the dialysis machine and the water treatment device are simultaneously controlled in order to ensure the successful implementation of a therapy. Controlling the two machines or devices can be difficult, particularly for elderly patients or paralyzed patients who may not be able to observe and / or manipulate the two devices easily and quickly. Visualization and / or input of information on or in both devices may be difficult. Both the dialysis machine and the water treatment device produce data whose storage may be desirable for analysis. The data must be accurate, synchronized and provide a sufficient level of detail. There is, therefore, a need for a home dialysis device which incorporates a water treatment device and a hemodialysis machine, so that the control of the two machines or devices is centralized, and so that the data can flow easily to and from both machines or devices. The invention will now be summarized below.

The device and method of the present invention integrate the control of a dialysis machine and a water treatment device, so that, in principle, the user controls the water treatment device from the dialysis machine. That is, the user interface for 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 main control of the water treatment device is through the dialysis machine. It is also envisaged to transfer data from the two machines to a central facility managed by a therapy provider, to provide treatment data reports for both the machine and the device to the clinicians, to integrate treatment systems. billing and ordering, track the use of consumables and deliver consumables as needed, and maintain and troubleshoot machines on a system network. For this purpose, in one embodiment, the dialysis machine is in digital communication with the water treatment device via Ethernet or other wired communication network. The dialysis machine itself is in communication with the system or network. In this way, the data from the water treatment device can be sent via the dialysis machine to the network or system. The system or network can similarly send control commands and software upgrades via the dialysis machine to the water treatment device.

The dialysis machine includes a home therapy machine, such as, but not limited to, a home hemodialysis machine ("HD"), a home peritoneal dialysis machine ("DP"), a machine hemofiltration ("HF") at home, a hemodiafiltration ("HDF") machine at home, and a continuous renal replacement therapy ("CRRT") machine. While renal therapy is at the center of the present invention, the present invention also contemplates the integration of any home fluid delivery therapy, such as, in addition, a home drug delivery therapy or a nutritional therapy. In various embodiments, home therapy is any type of therapy using a medical fluid that can be produced live, or at the start of use with a source of purified water, such as ultra-violet water. pure as this term is understood in the art. For example, while DP dialysis has, in general, been carried out using pocket dialysate, it is intended to produce a direct DP solution starting with the ultra-pure water source or Sterile water and adding DP concentrates, such as dextrose or concentrated glucose, as needed. It is also contemplated that home therapy is a nutritional therapy in which purified water from the water treatment device is used as a base to ensure the preparation of a nutritional solution that is delivered. to the patient. In any situation, all of the controls of the water treatment device are provided through the same user interface that is used to control the home therapy machine, whether in one embodiment. , a home blood treatment therapy machine, a DP home therapy machine or a home nutrition therapy machine. It is contemplated that the home medical device package will transfer the treatment requirements to the home therapy machine. A doctor's prescription for kidney or other type therapy at home is created. A clinician can remotely select, on the basis of the doctor's prescription, the supplies to be sent to the patient's home, including supplies for both the home therapy machine and the water treatment device. The clinician may also remotely adjust the operational parameters for controlling both the home therapy machine and the water treatment device. The operational parameters for both the machine and the device are sent to the home therapy machine. The operational parameters for the home therapy machine are stored in the memory of the therapy machine. The operational parameters for the water treatment device are transmitted from the home therapy machine to the water treatment device and stored in the memory of the water treatment device. The device and method of the present invention also allows the firmware upgrade on the home therapy machine and the water treatment device via the home therapy machine. When the upgraded firmware is produced, the firmware is sent to the home therapy machine. If the new firmware is for the home therapy machine, the new firmware is installed on the home therapy machine. If the new firmware is more for the water treatment device, the home therapy machine transmits the new firmware to the water treatment device in which it is installed.

In some jurisdictions, the user may be required to accept the software upgrade, either for the home therapy machine or for the water treatment device. In any case, it is envisaged to allow the user to accept the new firmware, either for the machine or for the device, at the user interface for the home therapy machine. It is envisaged to provide operational requirements and a new firmware with labels which designate which of the home therapy machine and the water treatment device is intended to receive the operating instructions or the firmware. Alternatively, the instructions and the firmware may be inherently similar to one or the other of the home therapy machine or water treatment device or may have content that is specific to one or the other. In the latter case, the home therapy machine can determine whether it itself accepts the firmware instructions or upgrade or transmits them to the water treatment device based on detected inherent characteristics. No additional labels are needed here. Based on the foregoing and the following description, it should be appreciated that an advantage of the present invention is to create an improved home therapeutic treatment using the production of purified live water.

It is another advantage of the present invention to provide home therapeutic device and method for hemodialysis, haemofiltration, hemodiafiltration, peritoneal dialysis, drug delivery and improved nutrition. It is another advantage of the present invention to provide improved devices and methods for sending operational parameters to multiple machines or devices of a home therapy system. It is yet another advantage of the present invention to provide clinicians, physicians and nurses the ability to remotely review and control data produced by cooperating multiple machines or devices to provide home therapy. It is yet another advantage of the present invention to provide an improved device and method for sending micro-software upgrades to cooperating multiple machines or devices to provide home therapy. It is yet another advantage of the present invention to ensure that the sending of data in one direction and the other between a server and multiple machines or devices cooperating to provide home therapy is implemented. works in a reliable and safe way. It is yet another advantage of the present invention to prevent data from being issued from a server to cooperating multiple machines or devices for performing home therapy while the machines or devices are in use. orders. Furthermore, it is an advantage of the present invention to allow a user to control certain aspects of a processing involving multiple machines or devices using a single user interface.

Additional features and advantages are described herein and will become apparent from the following detailed description and figures. A brief description of the figures is given below. Fig. 1A is a block diagram of an embodiment of a home medical device assembly according to the present invention.

Fig. 1B is a block diagram of an embodiment of a computing device used in the home medical device set according to the present invention. Fig. 2 is a block diagram of an embodiment of a dialysis machine with a water purification unit in a home medical device set according to the present invention. Fig. 3 is a schematic view of an embodiment of a subassembly comprising a water treatment device in communication with a home therapy machine for a home medical device assembly according to the present invention.

Fig. 4 is an algorithm of an exemplary method of the present invention for providing installation of a water treatment device. Fig. 5 is an algorithm of an exemplary method of the present invention for producing water with a water treatment device. Figure 6 is an algorithm of an exemplary method of the present invention for starting a home therapy machine and a water treatment device. Fig. 7 is an algorithm of an exemplary method of the present invention for upgrading a component in a water treatment device. Fig. 8 is an exemplary method algorithm of the present invention for providing transport inventory and scheduling of therapeutic prescription for home therapy machine and / or treatment device. of water based on an approved treatment prescription. Fig. 9 is an algorithm of an exemplary method of the present invention for providing firmware upgrade of a home therapy machine and / or a water treatment device. Figure 10A is a screen shot of an exemplary dashboard screen for a clinic of the present invention. Fig. 10B is a screen shot of an exemplary legend for a dashboard screen of the present invention. Fig. 11A is a screen shot of an exemplary treatment summary screen of the present invention. Fig. 11B is another screen shot of an exemplary treatment summary screen of the present invention. Figure 12 is a screen shot of an exemplary patient use report of the present invention. The detailed description will now be presented starting with a set of home medical device. Referring now to the drawings and particularly to FIG. 1A, a home medical device assembly 110 is shown. The assembly 110 presents a home therapy machine 100, which may be of any type including a home hemodialysis machine ("HD"), home hemofiltration ("HF"), hemodiafiltration machine. home ("HDF"), home peritoneal dialysis ("DP"), home drug delivery, or home nutrition therapy. If the home therapy machine 100 is a home hemodialysis machine, a suitable machine is defined in US Patent Application No. 2009/0105499, entitled "Modular Assembly for a Hemodialysis Device (Modular Assembly For A Hemodialysis System), filed Aug. 27, 2008. While a simple home therapy machine 100 is shown as communicating with a connectivity server 118, the set 110 oversees the operation of a plurality of therapy machines. at home 100, of the same type or of different types. For example, there may be a number M of hemodialysis machines 100, a number N of hemofiltration machines 100, a number 0 of hemodiafiltration machines 100, a number P of peritoneal dialysis machines 100, a number Q of 100 home drug delivery machines, and a number R of home nutritional therapy machines 100 connected to a server 118 and operating with a set 110. The numbers M to R may be the same or different numbers, and may be zero, equal to one or greater than one.

In the embodiment shown, the home therapy machine 100 receives at its front end purified water from a water treatment device 10. A suitable water treatment device 10 is defined in FIG. U.S. Patent Application 2011/0197971 entitled, "Water Purification System And Method", filed April 25, 2011. In one embodiment, the water treatment device 10 delivers ultrapure water as this term is understood in the art. The ultrapure water can be passed through one or more filters, such as an ultrafilter or a dialyzer to produce water of an injectable or medical quality or almost. The injectable grade water can then be mixed with one or more dry, liquid, or pasty concentrates to produce (i) an injectable solution for HF or HDF, (ii) a DP solution, (iii) a drug for infusion or (iv) a nutritional solution for infusion. The assembly 110 represents the fact that home therapy machines 100 operate with other devices, in addition to the water treatment device 10, such as a blood pressure monitor 104, a weigh scale, for example, a wireless weigh scale 106, and a wireless tablet-based user interface 122. Home therapy machine 100 is, in one embodiment, connected to server 118 by wireless connection through Each of these components, including the water treatment device 10, is generally located within the patient's home, as evidenced by the dashed lines. in Figure 1A. Any one or more or all of the components 10, 104, 106 and 122 may communicate by wireless wiring or link with the home therapy machine 100. Wireless communication may be provided by BluetoothTM, WiFiTM , Zigbee®, Z-Wave®, universal wireless serial ("USB") bus, infrared, or other suitable wireless communication technology. Alternatively, any one or more or all of the components 10, 104, 106, and 122 may communicate with the home therapy machine 100 through a wired communication link. In one embodiment, the water treatment device 10 is connected to the home therapy machine 100 via an Ethernet cable. The water treatment device 10 is, in one embodiment, powered by its own power source. The home therapy machine 100 may request water according to its needs from the water treatment device 10. The water treatment device 10 is sized and configured to deliver, on a live basis or in batch, any amount of water required by the machine 100. The connectivity server 118 communicates with most of the home medical device assembly 110 via a home medical device assembly gateway 120. The set gateway 120 allows the passage of data and information about each home therapy machine 100 and water treatment device 10 over the set 110 in one direction and the other through the server. connectivity 118 between the machines 100 and the other therapy clients connected to the server 118. In the embodiment shown, the set gateway 120 is connected to a service gate 130, a control system. enterprise resource planning 140, an Internet portal 150, a business intelligence portal 160, a HIPAA compliant database 124, a product development team 128 and electronic databases of medical records 126a-126n. Medical Record Electronic Databases ("EMRs") 126a to 126n contain electronic information about patients. The set gateway 120 may send the collected data from the log files of the machine 100, described in detail below, to the hospital or clinic databases 126a-126n in order to gather or complete the patient's medical records. Databases 126a to 126n may contain patient-specific treatment and prescription data and, therefore, access to such databases may be severely limited. The enterprise resource planning system 140 obtains and compiles data generated via the patient and clinician website access, such as claim and billing information and life management information. The Internet portal 150 enables patients and clinicians 152a-152n providing patient treatment to access an available public website for the set 110. The business intelligence portal 160 collects data from the gateway. together 120 and delivers data to the marketing department 162, research and development 164, and quality / pharmacovigilance 166.

The block diagram of the set will now be described. A block diagram of an embodiment for the electrical devices of any one or more or all of the machines, devices, or subassemblies of the home medical device assembly (e.g., the device 10, the machine 100, the modem 102, a blood pressure monitor 104, a weigh scale 106, a server 118, an assembly gateway 120, a user interface 122, a maintenance portal 130, a scheduling system 140, an Internet portal 150, a business intelligence portal 160) as shown in Fig. 1b. The assembly 110, comprising any one or all of the devices or subassemblies 10, 100, 102, 104, 106, 118, 120, 122, 130, 140, 150, and 160, comprises a main unit 170 which in one embodiment, includes one or more processing units 176 electrically coupled by an address / data bus 178 to one or more memory devices 174, other computer circuits 172, and one or more interface circuits 180. The processing unit 176 may be any suitable processing unit, such as a microprocessor of the INTEL PENTIUM® family of microprocessors. The memory 174 may include volatile memory and nonvolatile memory. The memory 174 can store one or more computer programs that interact with the other devices of the set 110 as will be described below. The memory 174 can also store digital data representative of documents, files, programs, web pages, etc., extracted from another computing device and / or loaded via an input device 194. The interface circuit 180 may be implemented using any appropriate 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 provide data and instruction input to the main unit 170. For example, the input device 194 may be a keyboard, a mouse, a touch screen, a selection block, a selection ball, a fixed point, 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 network (POTS), and / or other networks. One or more display devices, printers, speakers, and / or other output devices 192 may also be connected to the main unit 170 through the interface circuit 180. The display device 192 may be a cathode ray tube (CRT), a liquid crystal display (LCD), or any other type of display device. The display device 192 generates visual displays of data generated during the operation of the devices or subsystems 10, 100, 102, 104, 106, 118, 120, 122, 130, 140, 150, and / or 160. For example, the display device 192 may be used to display display information received from the set gateway 120. The visual displays may include invitations for human input, operating statistics, values One or more storage devices 190 may also be connected to the main unit 170 through the interface circuit 180. For example, a hard disk drive, a CD drive , a DVD player, and / or other storage devices may be connected to the main unit 170. It should be appreciated that the methods and procedures of the invention described herein can be implemented using a or several computer programs or components. These components may be in the form of a series of computer instructions on any conventional computer-readable medium, including random access memory ("RAM"), read-only memory ("ROM"), flash memory, magnetic or optical discs, optical memory, or other storage media. The instructions may be configured to be executed by a processing unit, which when executing the set of computer instructions implements or facilitates the implementation of all or part of the methods and procedures of the invention. The digital transfer for the water treatment device will now be described. In one embodiment, the home therapy machine 100 performs home treatment, such as home hemodialysis, on a patient in the patient's home and then reports the results of this treatment to clinicians, doctors, and nurses who are responsible for taking charge of the health and well-being of this patient. The treatment results include data that is delivered from the water treatment device 10 to the home therapy machine 100. The data of the water treatment device 10 may, for example, include a total volume of water. water delivered, the quality of the water delivered (eg, chlorine content), the number of times that the water treatment device 10 delivered water to the therapy machine 100 during a treatment (this can be monitored by the device 10 or machine 100), the average water flow delivered, any alarms or alerts experienced by the water treatment device 10 during a treatment, and / or a The duration or number of cycles executed during a process, for example, for component replacement information. The home therapy machine 100 writes log files using, for example, a LinuxTM operating system. The log files again document relevant home therapy machine data 100 and relevant water treatment device data during a course of treatment. Log files can include any one or more files in Extensible Markup Language ("XML"), Comma Separated Values ("CSV"), or Text. The log files are placed in a file server box of the home therapy machine software 100. It is contemplated to store at the water treatment device 10 data that is not sent to the machine 100. Such data may otherwise be obtained via the Ethernet digital link with the water treatment device 10 or downloaded via other digital links or storage media. For example, a maintenance person can access additional data via a portable computer connected to the water treatment device 10 via an Ethernet link. Also, the additional data can be retrieved remotely from the water treatment device 10, the home therapy machine 100 serving as a digital transfer link between the water treatment device 10 and the authorized system clients. as described here.

The home therapy machine 100, for example, via the Internet, utilizes a connectivity service to transfer data, including water treatment device data, between the modem 102 and the gateway. 120. In one embodiment, a dedicated line is arranged at the home of each patient to connect the home therapy machine 100 to the connectivity server 118 via the modem 102. The home therapy machine 100, in one embodiment, accesses the Internet using a modem, for example, 3G, 4G or 5G separate. The modem 102 uses an Internet Service Provider ("ISP"), such as VodafoneTM. In one implementation, a connectivity agent 114 developed by a connectivity service provider (e.g., connectivity server provider 118) is installed on the home therapy machine 100 and is implemented on a home network. Main Control Processing Unit ("ACPU") 112. An appropriate connectivity service is provided by AxedaTM. The connectivity service provides a secure connection 116 between the medical devices and the connectivity server 118.

The connectivity agent 114 enables the home therapy machine 100 to connect the connectivity server 118 and transfer data, including data from the water treatment device 10, to the connectivity server 118 and from there. latest. The connectivity service operating through the agent 114 and the server 118 ensures the security of the link with the machine 100, ensures that the data passes correctly through the firewall of the machine 100, checks if there is has had data or system losses and checks whether the connectivity server 118 communicates and ensures that it is with the right home therapy machine 100. In one embodiment, the home therapy machine 100 can only be connected to the connectivity server 118 when the connectivity agent 114 is activated. During treatment and disinfection after treatment, while the machine 100 and the water treatment device 10 are operating, the connectivity agent 114 is disabled. This prevents the home therapy machine 100 from communicating with any entity and sending or receiving data during processing and disinfection or when the machine 100 is turned on or in operation. When the home therapy machine 100 is idle, for example, after completion of the subsequent treatment or disinfection, the ACPU 112 activates the connectivity agent 114. In one embodiment, the connectivity agent 114 is disabled only during processing (including pre-treatment). The connectivity agent 114 then extracts the log files from the home therapy machine 100 and transfers the data, including data from the water treatment device 10, to the connectivity server 118 using the connectivity service. The connectivity service routes the data packets to their own destination, but in one embodiment does not modify, access, or encrypt the data. In the assembly 110 of FIG. 1A, the connectivity service via the connectivity server 118 may communicate data to different locations via a set gateway 120, a gateway of 130 and an Internet portal 150. The connectivity server 118 enables the 132a 132n service personnel and / or the clinicians to track and retrieve various items across the network, such as home and computer therapy 100 machines. 3G, 4G or 5G 102, and their associated information, including serial numbers of machine or modem. The connectivity server 118 may also be used to receive and deliver software upgrades, approved by a maintenance manager 134 and remotely obtained through a maintenance portal 130, to the machines. licensed home therapy 100 and their associated water treatment devices. In one embodiment, a connectivity agent 114a (not shown) may also be installed on the water treatment device 10, in addition to being installed on the home therapy machine 100. 100 home can not communicate with the set gateway 120, and the set gateway 120 must communicate with the water treatment device 10, the water treatment device 10 can then communicate directly with the gateway together 120 through the connectivity agent 114a. Alternatively, the connectivity agent 114a may be installed on a separate device or unit (not shown), which may be selectively connected to the water treatment device 10, such that the water treatment device 10 can be transformed to communicate directly with the set gateway 120 again, for example, if the home therapy machine 100 loses communication with the set gateway 120. Maintenance of the water treatment device will now be described. In one embodiment, the home therapy machine 100 can be operated in the maintenance mode so that maintenance personnel can access both the home therapy machine 100 and the treatment device. water 10 on site and / or remotely, diagnose and troubleshoot. For example, if the water treatment device 10 encounters a problem, or if a component thereof, for example, a chemical supply, is worn out, the patient may call a maintenance person or technician. The patient and / or service personnel can then place the water treatment device 10 through the home therapy machine 100 in a maintenance mode that allows the service technician to remotely check the Device 10 Settings and Features for Different Components of the Water Treatment Device 10. In one embodiment, the assembly 110 prevents processing while the service technician is connected to the machine 100 to enhance security. .

For example, the service personnel can connect to the device 10 via the machine 100 while the process is suspended. Alternatively, the machine 100 must be in an inactive state, or even put out of service, so that the maintenance personnel can access the machine 100 and / or the device 10. Still alternatively, the machine 100 may only have to be disconnected from the patient so that the maintenance personnel can access the machine 100 and / or the device 10. Once connected, the service technician can remotely investigate and extract the log files stored on the therapy machine. home 100 for the water treatment device 10 to determine a cause of an error occurring on the water treatment device 10. The maintenance personnel can also trigger valves and activate a pump, for example, to verify whether a sensor associated, for example, a pressure sensor, the water treatment device 10 is operating properly and / or whether a valve or pump of the water treatment device 10 is operating correctly. t. The maintenance personnel do this by sending an instruction to the home therapy machine 100. The home therapy machine 100 identifies that the instruction is for the water treatment device 10 and transmits the instruction to the therapy device. processing and memory of the water treatment device 10, thereby causing the appropriate action on the water treatment device 10 to be implemented. The water treatment device 10 returns response data to the water treatment device 10. home therapy machine 100, which relays the information back to the appropriate maintenance person. The requests sent by the service personnel can be structured so that the machine 100 inherently recognizes the request for either the home therapy machine 100 or the water treatment device 10. Alternatively, the request can be labeled. For example, the valves of the home therapy machine 100 may be numbered consecutively starting from number one, while the valves of the water treatment device 10 may be numbered consecutively starting from the number one hundred (assuming that the machine home therapy 100 has less than one hundred valves). Here, it is known, inherently, to transmit a request for tilting of a one hundred eleven valve to the water treatment device 10. In a variant, the valves of both the home therapy machine 100 and the device The water treatment units 10 may be numbered consecutively from number one, but when the requests are coded, for example, "A" for the home therapy machine 100 and "B" for the water treatment device 10 Here, the ACPU unit 112 of the home therapy machine 100 knows how to keep a request for triggering an AV4 valve and transmit a valve switching request BV4 to the water treatment device 10.

The command via a user interface is then explained. In one embodiment, the control unit (ACPU unit 112) and the user interface 122 of the home therapy machine 100 accompany the patient through the entire process of treatment and inform, on a non-random basis. in step, the manner in which the processing is to be initiated and implemented, including control instructions of the water treatment device 10. In one embodiment, the user interface 122 is a tablet that performs a personalized secure interface, which only allows access to the home therapy machine 100. In one implementation, the tablet 122 operates remotely. The tablet 122 can here be connected to the home therapy machine 100 initially to ensure the adaptation of the tablet 122 to the home therapy machine 100 and to perform software upgrades (e.g. of the tablet 122. The tablet 122 may also be connected to the home therapy machine 100 to power or charge the tablet 122. The cormectivity between the tablet 122 and the therapy machine Home 100 can be provided via a serial digital link, a universal serial bus ("USB") link, a parallel link or through another suitable digital transfer interface. Once the tablet 122 is coupled to the home therapy machine 100, the tablet 122 wirelessly communicates (e.g., using BluetoothTM or WiFiTM) with the home therapy machine 100. The interface Alternatively, the user 122 may be connected to or connected to the machine 100, for example, as shown and described in US Patent Application No. 2009/0115458. A connected or connected arrangement for a user interface 122 is therefore, as described below, as shown in FIG. 3. In one embodiment, the user can send data to the machine 100 and receive data from the machine via the tablet. 122. The data entered in the user interface 122 is securely sent to the home therapy machine 100 and processed in the ACPU 112, which controls the machine 100 or transmits instructions for processing. r by the water treatment device 10, which in turn controls certain operations of the water treatment device 10. In one embodiment, no processing data is stored in the tablet 122. The non-storage of Processing data in the tablet 122 is advantageous because if the tablet 122 is disconnected or lost, no sensitive or important data is lost. Since the user interface 122 of the home therapy machine 100 is also used to input and display data associated with the water treatment device 10, the water treatment device 10 does not require, And in one embodiment there is no more than a simple display device, which may be equipped with some electromechanical buttons, such as membrane switches, and an on / off switch. The simple display device may be a small liquid crystal display ("LCD") device or a light emitting diode ("LED") display device, which provides a single line or a few lines of text. The electromechanical buttons allow the emergency control of the water treatment device 10 in the event that the tablet 122 is lost or where the communication between the home therapy machine 100 and the water treatment device 10 is broken. . The electromechanical buttons allow, in a variant or in addition, the installation or the maintenance of the water treatment device 10 in the absence of the home therapy machine 100. The electromechanical buttons can also allow personnel to maintenance to enter a maintenance mode directly from the small keyboard, for example, by pressing and holding a hidden button for a specified number of seconds. In one embodiment, the user can activate and deactivate the home therapy machine 100 and / or the water treatment device 10 from the common user interface 122. A user can send an instruction to the water treatment device 10 from the common user interface 122. The instruction may, for example, request the water treatment device 10 to provide an estimate of the time remaining before a component consumable of the water treatment device 10 must be replaced. For example, the water treatment device 10 may comprise a carbon filter, a sediment removal cartridge, a softening filter, a reverse osmosis membrane ("ROI") or a metal catalyst filter, which must each be replaced after a certain number of hours of use.

As before, the instruction from the tablet 122 may be inherent to the water treatment device 10, so that the ACPU 112 has only the choice to transfer the instruction to the processing device of the device. water 10. Otherwise, the instruction may be associated with a code that the ACPU 112 identifies, after which the ACPU 112 transmits the instruction to the water treatment device 10. A goal of the present invention is to prevent the user from having to look at two different user interfaces when performing the home therapeutic treatment under the set 110. In addition, allowing the user interface 122 or a common user interface, it is contemplated that the water treatment device 10 requires as little user interaction as possible. For example, the water treatment device 10 may be configured such that it remains energized indefinitely without any adverse effect on the water treatment device 10. Otherwise, the home therapy machine 100 and the Water treatment 10 may be configured such that the water treatment device 10 is energized in the case where the home therapy machine 100 is powered. Similarly, many instructions for the home therapy machine 100 may implement or exhibit an automatic side effect on the water treatment device 10. For example, a PAUSE or STOP input from the User interface 122 to home therapy machine 100 may similarly cause the automatic production of a PAUSE or STOP instruction by the home therapy machine 100 for the water treatment device 10. In another example, if the home therapy machine 100 enters an alarm state while receiving purified water from the water treatment device 10, the home therapy machine 100 can stop pumping. water from the water treatment machine 10. Certain operational parameters of the home therapy machine 100 may also dictate operating parameters of the water treatment device For example, in the hemodialysis treatment, a dialysis fluid or dialysate flow entered as an operational parameter in the home therapy machine 100 may dictate the set flow rate of the water treatment device 10 to produce the purified water. which is used to produce the dialysis fluid or dialysate. This leader / follower operational parameter arrangement can be implemented in a plurality of different ways. In a first way, the home therapy machine 100 unit 100 of the home therapy machine 100 calculates or finds through a table of value the operational parameter for the water treatment device 10 based on the parameter -24. - For example, the ACPU 112 can memorize that this purified water flow rate should be set to 1.2 times the dialysate flow rate. The ACPU 112 calculates and adjusts in real time a purified water flow rate knowing the current or current actual dialysate flow rate for the home therapy machine 100. In one embodiment, the ACPU 112 may adjust the flow of purified water if the ACPU 112 determines that the patient requires a bolus of fresh solution. Another suitable method for delivering a bolus of fresh solution to the patient is determined in US Patent Application Serial No. 2009 / 0126,963, entitled, Balanced Flow Dialysis Machine (Balanced Flow Dialysis Machine). November 9, 2007. In a second way, the control unit of the water treatment device 10 calculates or finds, via a table of value, the operational parameter for the water treatment device 10 on the basis of the corresponding operational parameter for a home therapy machine 100 sent by the home therapy machine 100 to the water treatment device 10. For example, the control unit of the water treatment device It can be memorized that the flow of purified water must be adjusted to 1.2 times the dialysate flow rate. The ACPU 112 sends the current dialysate flow periodically to the water treatment device 10, which accordingly calculates and adjusts in real time a purified water flow knowing the actual or controlled actual dialysate flow rate. In a third way, the control unit of the water treatment device 10 executes a prescription just like the home therapy machine 100. It is described below a method of wherein the home therapy machine 100 receives one or more of the machine control prescriptions from a remote physician or clinician via the server 118 and the set gateway 120 described above. When a machine control prescription is installed on the home therapy machine 100's unit ACPU 112, the prescription arrives with a set of secondary instructions or prescription that is transmitted from the ACPU 112 to the control unit of the water treatment device 10. When this prescription for the home therapy machine 100 is then recalled by the user for treatment via the home therapy machine 100 the corresponding set of instructions or secondary prescription is recalled for use with the water treatment device 10. In this third way, the data update during the treatment between the home therapy machine 100 and the water treatment device 10 can be reduced or eliminated. A fourth way acts on a batch or volume basis. The home therapy machine 100 may include a dialysate holding tank. The ACPU 112 may be configured to produce dialysate when the reservoir volume drops to a certain level and stops the dialysate production when the reservoir volume rises to a certain level. Here, the water treatment device 10 is responsible for supplying enough water to raise the small volume of dialysate reservoir to the high dialysate reservoir volume as opposed to having to provide the dialysate flow rate of the dialysate. dialyzer. When the reservoir volume reaches this low level, the ACPU unit 112 activates the water treatment device 10 and the dialysate mixing pumps of the home therapy machine 100 to produce dialysate and attempt to fill the dialysate storage tank. The water treatment device 10 and the dialysate mixing pumps remain activated until the defined high reservoir volume is reached. It is contemplated to maintain different dialysate production rates for the water treatment device 10 and the dialysate mixing pumps, so that if the water treatment device 10 and the dialysate mixing pumps can not meet the demand at a lower production rate, they can lead to a higher dialysate production rate. When the ACPU 112 increases or decreases the dialysate production rate, both the water treatment device 10 and the dialysate mixing pumps are adjusted accordingly. While the dialysate flow rate / purified water flow and / or volume control has been used to represent the leader / follower operational parameter arrangements, it is expressly contemplated to use the arrangement with other parameters, such as parameters relating to the pressure, the temperature and / or the purity level of the water leaving the water treatment device 10. Referring now to FIG. 100a dialysis comprises a water purification unit 10a, a dialysate preparation unit 224, a dialysate delivery unit 230 and a disinfection unit 226. The control unit 232 in one embodiment has a plurality of control units, each comprising a processing element and a memory. The control unit 232 may, for example, comprise a master or supervisory processing unit which controls a plurality of slave processing units, each of which is dedicated to different functions associated with the dialysis machine 100a. The control unit 232 may also include a redundant processing element, such as a security processing unit which ensures that each of the other processing units performs its function correctly. The control unit 232 may control any one or more of the water purification unit 10a, the dialysate preparation unit 224 and the disinfection unit 226 in addition to the control of a device 234, pumps 236, valves 238 and sensors 240. The home therapy machine and the water treatment device are shown as being distinct in FIG. 1A, but they may be in the same housing, as shown in FIG. 2. In one embodiment, the same user interface 122 may be used to control the control unit 232, which may control any one or more of the different units, for example , the home therapy machine as well as the water treatment device. The dialysis machine 100a may be powered by an auxiliary power supply 212 and / or a backup power source 214. The digital link will now be described. Referring now to FIG. 3, FIG. System 50 of an assembly 110 between the water treatment device 10 and the home therapy machine 100. By reference, the simple display device and the electromechanical buttons described above for the treatment device of the present invention. water 10 are represented by the display device 20 and the electromechanical buttons 22. Alternatively, the water treatment device 10 only includes the display device 20 and has only rudimentary input devices. The display device on the water treatment device 10 can enhance the user interface 122. The control process and memory for the water treatment device 10 is represented by the processing and memory element 24. In addition, as previously mentioned, the user interface 122 of the home therapy machine 100 is shown as being connected to or connected to the home therapy machine 100. The user interface 122 is, alternatively, a non-connected tablet, as has been described here. As shown in FIG. 3, a digital communication link 32, for example, an Ethernet or wired communication link, is provided to transmit data between the processing element and the memory 24 of the processing device. In one example, the water treatment device 10 uses the link 32 to send to the home therapy machine 100 status information. or condition, component lifetime information, sensor levels or measurements, self test results, alert and alarm information, and hardware and / or software version information. The water treatment device 10 may also indicate information regarding the flow of water between the water treatment device 10 and the home therapy machine 100 including flow information, water temperature information and connection line disinfection information. As also shown in FIG. 3, the communication link 32 may also be used to transmit data between the ACPU 112 of the home therapy machine 100 and the processing and memory element 24 of the patient's therapy device. water treatment 10. As described above, or in addition to what has been said, the home therapy machine 100 can send data to the water treatment device 10 for requests for treatment. state change, instructions (eg, EXECUTION, PAUSE, or STOP), status requests, rate change requests, software upgrades or restorations, and / or a prescription file, for example of device, of transfers.

As described herein, the user interface 122 indicates information about the water treatment device 10 to the user 12. For example, the user interface 122 may display to the user 12 information such as an alarm or alert notification, water treatment device operating information, troubleshooting assistance, a user guide and / or action requests. For example, the user 12, through the user interface 122, may request the water treatment device 10 to identify itself to ensure that a digital link 32 between the machine 100 and the device 10 functions correctly and to check the compatibility, such as the compatibility of the hardware version and the software version, between the device 10 and the machine 100. If this is the case, the device 10 can itself issue an audible signal or respond and / or return a confirmation message to the user interface 122, for example, "I am here". the user 12 can then take an appropriate action, either via the user interface 122 or by performing a certain task indicated by the user interface 122. To do this, the user 12 only needs interact with the common user interface 122. In this way, the interaction of the user 12 with the water treatment device 10 may be minimal, so as to perform a commissioning and out of material service, realize physical digital and power links, making filter changes and / or taking manual measurements, while ensuring that the water treatment device 10 is operating properly and communicating with the machine 100. In addition to the digital link 32 between the home treatment machine 100 and the water treatment device 10, a water supply line 34 extends from the water treatment device 10 to the home therapy machine 100 The water supply line 34 delivers water at a sterility level, flow rate, pressure and / or temperature specified to the home therapy machine 100. The water sent from from the water treatment device 10 to the home therapy machine 100 is conventionally stored at about 5 ° C to 35 ° C. Line 34 may, in one embodiment, be used to return unused produced water from the home therapy machine 100 to the water treatment device 10. In one embodiment, the treatment element and memory 24 of the water treatment device 10 functions as a slave or delegated processing unit with respect to the programmed ACPU 112 of the home therapy machine 100. The water treatment device 10 can inform the machine home therapy 100 of its state, such as an alarm situation, and sends any other relevant data to the ACPU unit 112. The home therapy machine 100 memorizes and acts on the data, for example, decides you have to set off an alarm. The home therapy machine 100 thus controls the behavior of the water treatment device 10. The water treatment device 10 may be in one of several different states, such as "Installation", "Device Rinse", " Hibernation "or" Therapy "The home therapy machine 100 is, in one embodiment, responsible for requesting that the water treatment device 10 change state, for example," Hibernation "to" Therapy. In "Hibernation", the water treatment device 10 is maintained in a state of minimum power consumption.In "therapy", the water treatment device 10 is brought to a maximum possible power level. As previously described, the present apparatus and method contemplates many ways of coupling the water treatment device 10 to the home therapy machine 100 upon water demand by the home therapy machine 100. At each al Alternatively, the water treatment device 10 provides water suitable for treatment, and in an appropriate amount or flow rate, to the home therapy machine 100.

The water treatment device 10 may send information to be displayed on the user interface 122 to prompt necessary user actions.  The water treatment device 10 may send status information to the home therapy machine 100 asynchronously or in response to a request for status.  The water treatment device 10 can also send error packets to the home therapy machine 100 in case of error or alarm.  The home therapy machine 100 may decide which actions are to be taken and whether the user 12 should be informed through the user interface 122.  If the user 12 has to produce any input to clear the alarm, the user 12 can do it through the user interface 122.  The water treatment device 10 is responsible for notifying its current state to the home therapy machine 100.  The water treatment device 10 is also responsible for the notification of any alarms or alerts to the home therapy machine 100.  When water is required for therapy, the home therapy machine 100, in a previously described embodiment, specifies the desired water flow rate to the water treatment device 10.  The water treatment device 10 then delivers water at the desired rate.  Or, as previously described, the water treatment device 10 calculates or extracts its flow rate based on a therapy fluid flow rate sent from the home therapy machine 100.  Or, as previously described, the water treatment device 10 determines its flow from its own device prescription.  In addition, as previously described, the water treatment device 10 and the home therapy machine 100 may instead cooperate on a volumetric basis.  It should be appreciated that the use and control of both the water treatment device 10 and the home therapy machine 100 from the user interface 122 increases security, minimizes the complexity of the therapy. activation of multiple devices and reduces the burden of therapy on home patients.  The operation of the water treatment device 10 and the home therapy machine 100 is also streamlined through the master / delegate processing unit arrangement.  The installation of the water treatment device will then be explained.  It is contemplated, under all 110, that the water treatment device 10 and the home therapy machine 100 will work together in many different ways, which is facilitated in many cases by the interface of the present invention. common user 122.  Referring now to FIG. 4, for example, the method 400 represents an exemplary method of initial installation or setup of the water treatment device 10 using the user interface 122 of the therapy machine. at home 100.  Upon initiation of the process 400 at the starting oval block, a user 12 connects the water treatment device 10 to the home therapy machine 100, for example, as shown in block 402, performs the link digital 32 and the water line connection 34 described above.  The user interface 122 during the detection of the digital link asks the user 12 if the user wishes to be guided during the installation of the water treatment device 10, as shown in block 404 .  If user 12 selects "no", process 15 ends at the oval block near block 404.  If the user 12 selects "yes", the user interface 122 asks the user 12 to first install an osmosis cartridge OI and to press "confirm" on the user interface 122, as shown in block 406.  When the user presses "confirm", the home therapy machine 100 requests the water treatment device 10 if the cartridge CH is detected and installed correctly, as shown in block 408.  If the cartridge () I is not detected or is not installed correctly, the water treatment device 10 returns an error condition, as shown in block 410, and displays an error message on the user interface 122, as shown in block 411.  If the OI cartridge is detected and correctly installed, the water treatment device 10 responds to the user interface 122 that the OI cartridge is present and delivers information on the cartridge to the home therapy machine 100, such as this is shown in block 412.  Next, the user interface 122 displays to the user 12, "Now 30 install the preprocessing cartridge and press to confirm", as shown in block 414.  When the user 12 installs the cartridge and presses to "confirm" at the user interface 122, the home therapy machine 100 requests the water treatment device 10 whether or not the treatment is present; as shown in block 416.  If the pre-treatment cartridge is not present or there is an error, the water treatment device 10 responds with a pre-processing cartridge error, as shown in block 418, in which case the user interface 122 displays a message to the user 12 in that the preprocessing cm-key is not installed correctly, as shown in block 420.  If the pre-treatment cartridge is present, the water treatment device 10 responds that the pre-treatment cartridge is present and delivers cartridge information to the home therapy machine 100, as shown in block 422.  Then, the user interface 122 displays a message to the user 12 requesting to connect the water treatment device 10 to the water supply, to activate the water supply and to press on "confirm" as shown in block 424.  When the user presses "confirm", the home therapy machine 100 requests the water treatment device 10 if the water supply has been connected and / or the water supply pressure is acceptable, as shown in block 426.  Then, the user interface 122 asks the user 12, to "Place the purge line in the drain, and ensure that an air gap is present", as shown in block 428 .  Once the user 12 has confirmed these steps, the user interface 122 displays a message to the user 12 informing that the water treatment device 10 will start rinsing and that the rinsing may take several hours, as shown in block 430.  The user interface 122 also displays a "rinse" button.  Once the user 12 presses the "rinse" button displayed, the water treatment device 10 begins flushing, as shown in block 432.  A separate "rinse" button must therefore not necessarily be arranged on the water treatment device 10, although one may be provided to provide redundancy.  In any case, the water treatment device 10 changes its state for "rinsing" and informs the home therapy machine 100 of this state change, as shown in block 434.  User interface 122, displays "Rinse.  Press the stop button to interrupt the "rinse" operation, and accordingly display a "Stop" or "Pause" button, as shown in block 436.  The water treatment device 10 may also report the status of its valves and pumps, in addition to its overall device mode, as shown in block 438.  When the flush is complete, the user interface 122 displays that the flush is complete, as shown in block 440.  A change of state is also reported to the home therapy machine 100, as shown in block 442.  The process 400 then ends as shown in the end oval block.  It should be appreciated that although the steps of the method 400 involve performing specific functions on the water treatment device 10, the instruction display and the user inputs therefor are provided on the user interface 122.  Thus, the user 12 can focus solely on the user interface 122 to install the water treatment device 10 and execute the treatment on the home therapy machine 100.  The water production will now be described. Fig. 5 shows an example of a water production process 500 with the water treatment device 10 using the user interface 122 of the home therapy machine 100.  Upon starting process 500 at the starting oval block, the home therapy machine 100 causes the water treatment device 10 to activate or "wake up" and produce water at the specified flow rate (or until a specified volume of dialysate is reached in the dialysate storage tank), as shown in block 502.  In one embodiment, the water treatment device 10 performs necessary functions before producing water.  By activating or waking up, the home therapy machine 100 performs start-up activities, such as self-tests, rinsing, and security checks.  When the water treatment device 10 has completed the required activities, the device "wakes up" and is ready to produce water, as shown in block 506.  The home therapy machine 100 continuously requests the status of the water treatment device 10 and displays such a state on the user interface 122, as shown in block 508.  When the water treatment device 10 has completed its waking and is ready to produce purified water, if the home therapy machine 100 is occupied, as shown in block 510, the water treatment device 10 is waiting for the home therapy machine 100 to pump water, as shown in block 512.  Once the home therapy machine 100 is ready, the home therapy machine 100 begins pumping water, as shown at block 514.  A user interface 122 displays to the user 12 that the home therapy machine 100 pumps water from the water treatment device 10, as shown in block 516.  The user interface 122 may also provide an option for the user 12 to change the water preparation rate of the water treatment device 10 or to interrupt or stop the production thereof. .  Or, as previously described, the home therapy machine 100 may instruct the water treatment device 10 to change the rate based on instructions stored in the ACPU 112.  The water treatment device 10, in one embodiment, is configured to change its recovery ratio on the basis of demand.  The RO units of the water treatment device 10 produce a water discharge.  The water discharge can be recycled and delivered back to the RO units, reducing the water actually discharged into the drain, but doing this can reduce the life of the units C il because the supply of the RO units by recycling the water discharge can lead to clogging.  However, in the case where the home therapy machine 100 does not use all the available purified water flow produced by the water treatment device 10, the water flow discharged by the RO units may be mixed with excess purified water, creating a solution that is functionally equivalent to mains water, and that will not cause excessive clogging of RO units.  In this manner, the water treatment device 10 can adjust the amount of water discharged RO units to be recycled based on the availability of unused purified water which can be mixed with the reject stream before re-entering. in the OI units.  When the home therapy machine 100 has finished pumping water, the home therapy machine 100 instructs to hibernate to the water treatment device 10, as shown in block 518. .  In hibernation, the water treatment device 10 continues to communicate with the home therapy machine 100 to await a possible wake up instruction again.  In addition, in hibernation the water treatment device 10 may periodically run rinses of its flow path after periods of stagnation defined so as to maintain its performance in the absence of a wake up instruction.  The water treatment device 10 changes its state to hibernation and transfers its status to the home therapy machine 100 for display to the user 12, as shown in block 520.  The process 500 is then completed as shown in the end oval block.  Starting the Home Therapy Machine and the Water Treatment Device Fig. 6 shows an example of a start-up process 600 of the home therapy machine 100 and the water treatment device 10 using the interface. 122 of the home therapy machine 100.  Upon starting process 600 at the start oval block, the user interface 122 guides the user 12 through startup tests associated with the water treatment device 10, as shown in block 602.  For example, the user interface 122 may prompt the user 12 to control and execute self-tests for the UV light intensity, the OI rejection percentage, and the total organic carbon level ( "TOC"), each being associated with the water treatment device 10.  Other self-tests associated with the water treatment device include, for example, whether or not the life of the remaining pre-treatment cartridge is sufficient.  Self-tests of the water treatment device 10 may include a chlorine / chloramine test.  For example, the ACPU 112 may decide that a chlorine / chloramine test must be performed.  The user interface 122 may require the user to collect a water sample from the treatment device, water for testing, possibly by pressing a button on the interface. 122.  A chlorine / chloramine test is carried out, as shown in block 603, and the user interface 122 displays to the user the chlorine / chloramine test result options (e.g., Correct or Defective). and may ask the user for an answer, as shown in block 606.  Depending on the result of the chlorine / chloramine test, the method 600 may either perform other self-tests for the device 10, return to the self-tests of the home therapy machine 100 or proceed to a different task for the device. water treatment 10.  The method 600 can, therefore, switch between the different steps 602 and 603 as shown by the two-way arrows between the steps 602 and 603.  For example, if the water treatment device 10 does not satisfy the chlorine / chloramine test, the home therapy machine 100 may signal to the water treatment device 10 that a pre-treatment exchange is required or the sample must be tested again to confirm a defect.  The water treatment device 10 changes its state of system to that of "Cartridge exchange" and confirms the change of state to the ACPU 112 unit.  The user interface 122 displays to the user 12 the need for a pre-treatment cartridge exchange on the water treatment device 10.  The user interface 122 then guides the user 12 through the steps to ensure the exchange of the pre-processing cartridge.  All errors from the water treatment device 10 are displayed to the user 12 via the user interface 122, or the user interface 122 may ask the user for a response, as shown in block 606.  Upon completion of the exchange steps of the pre-treatment cartridge, the water treatment device 10 changes its state and transfers its status to the home therapy machine 100 for display to the user. 12.  If all the self-tests associated with the water treatment device 10 show positive results without errors, the user interface 122 makes a transition to perform the self-tests for the home therapy machine 100, such as this is shown in block 604.  Alternatively, the ACPU 112 may alternate self-tests between the home therapy machine 100 and the water treatment device 10.  In other words, it may not be desirable to first run all self-tests of the home therapy machine 100 and then run the self-tests of the water treatment device 10, or vice versa. versa, as previously described.  Self-tests can be run alternately or simultaneously.  The method 600 can therefore switch between steps 602, 603 and 604 as shown by the two-way arrows between steps 602 and 603 and 602 and 604.  At any time, the self-test of either of the home therapy machine 100 or the water treatment device 10 may display a result to a user 12 or request a response from the user user interface 122, as shown in block 606.  Such nesting of tests increases efficiency and saves time, while allowing user 12 to monitor only one user interface 122.  The method 600 ends as shown by the ending oval block, and may terminate from any of steps 602, 603, or 604, depending on the results of the self-tests and the level of nesting between self-tests.  The implementation of a pre-treatment / membrane cartridge exchange will be explained below.  Fig. 7 shows an exemplary method 700 for performing a pre-treatment cartridge exchange on the water treatment device 10 using the user interface 112 of the home therapy machine 100.  Upon starting process 700 at the starting oval block, the water treatment device 10 checks whether the pre-treatment cartridge is fully degraded, as shown in block 702.  If the pre-treatment cartridge is not fully degraded but needs to be changed quickly, the water treatment device 10 transmits an alarm on the digital link 32 to the home therapy machine 100, as shown in FIG. block 704.  The user interface 122 displays that the preprocessing cartridge must be changed quickly and presents options and selection buttons to the user 12 in order to know if the user 12 wishes to change the preprocessing cartridge now or later in one embodiment, as also shown in block 706.  If the user selects, through the user interface 122, to change the preprocessing cartridge later, the method 700 terminates as shown at the end oval block.  If the user selects, through the user interface 122, to change the preprocessing cartridge now, the process 700 proceeds to step 712, as will be described below.  If the pre-treatment cartridge is fully degraded and needs to be changed immediately before the water treatment device 10 can produce water, the water treatment device 10 transmits an alarm on the digital link 32 to the home therapy machine 100, as shown in block 708, which causes the user 12 to be displayed by the user interface 122 because the pre-treatment cartridge must be changed immediately, as this is shown in block 710.  If the user 12 selects at the user interface 122 to change the preprocessing cartridge now (in the case where the preprocessing cartridge is not needed), or the pre-process cartridge - processing must be changed immediately, the user interface 122, in one embodiment, guides the user 12 through the process of changing the pre-treatment cartridge, as shown in block 712.  Instructions for user tasks are displayed on the user interface 122.  Once the pre-treatment cartridge exchange is complete, the water treatment device 10 changes its state, as shown in block 714, which is displayed to the user 12 via the user interface 122, as shown in block 716.  In various embodiments, the method 700 may alternatively or in addition be used to implement an OI membrane exchange.  The method 700 is then completed as shown in the end oval block.  The prescription of preparation and use of supplies and therapy will then be explained.  The medical products and drugs are transported or delivered to the patient's home for the home therapy machine 100 to be used during the course of treatment.  Typically, only therapy products or drugs approved under the prescription of a physician may be transported to the patient's home.  U. S. such prescriptions typically last one year, and patients may have more than one prescription at any given time to dynamically manage their condition.  One or more prescriptions are stored for each patient on the set gateway 120.  Each home therapy machine 100 uses sources and settings according to the prescription.  If the patient's prescription changes or a prescription is added, the patient's clinician uses the Internet portal 150 to update the settings of the home therapy machine 100 so as to change or add the prescription.  If the settings for the home therapy machine 100 are updated, the set gateway 120 sends the updated settings to the home therapy machine 100 via the connectivity service, as previously described, for example, in one embodiment, the home therapy machine 100 communicates only with the set gateway 120 when the connectivity agent 114 is enabled.  Referring now to FIG. 8, the method 800 represents an example of a delivery method of supplying and programming a prescription for the home therapy machine 100 based on the physician's prescription for a particular patient.  That is, a physician associated with the clinic 152a-152n can also access the set gateway 120 via an Internet portal 150 to provide a therapeutic prescription for the patient (used both for supplies and machine operation) to the clinician.  Upon starting process 800 at the oval starting block, the clinician retrieves an electronic prescription prescribed by a physician using the Internet portal 150, as shown in block 802.  On Internet Portal 150, the clinician selects the dialyzer, the blood transfer tubing set, the acid, the bicarbonate, the needles, and so on.  and any other supplies, including any supplies for the water treatment device 10, necessary to meet the prescription to operate the home therapy machine 100.  The selected dialyser and other supplies will be transported to the patient's home, as shown in block 804.  At an identical or different time, the clinician can remotely access the set gateway 120 through the Internet portal 150 to schedule a prescription for the home therapy machine 100, as shown in block 806.  The set gateway 120 retains the therapeutic prescription, in one embodiment, until the connectivity agent 114 on a home therapy machine 100 is activated, as shown in blocks 820 to 824.  The clinician defines various treatment parameters used to schedule a prescription for the home therapy machine 100, as shown in block 808, such as blood flow, dialysate flow, UF volume, and a flow of heparin rinse.  In one embodiment, the settings specified by the clinician include the activation settings of the water treatment device 10 or may affect the parameters of the water treatment device 10, as previously explained, of so that the separate parameter setting of the water treatment device 10 is not necessary.  Or, the clinician may separately define different treatment parameters used to program a prescription for the water treatment device 10, as shown in block 810.  The clinician also specifies the allowed ranges for the different parameters, as shown in block 812.  That is, the patient may be allowed to select a value within a range of values for certain parameters under the specified therapeutic prescription.  In this way, the patient has a certain level of control over the treatment that is implemented.  The dialysate temperature may, for example, be set within a range of allowed values based on the preferences and comfort of the patient.  The clinician further specifies whether or not the patient has the ability to change the parameters as a whole, as shown in block 814.  If the patient is allowed to change the parameter values, the parameter variability is within an allowable range, so that the patient selects a value within the range specified by the clinician at block 812. .  The clinician then submits the parameters to the set gateway 120, as shown in block 816.  The set gateway 120 then sends the therapeutic prescription to the connectivity server 118, as shown in block 818.  When the connectivity agent 114 residing at the home therapy machine 100 is then activated or enabled, as shown in block 820, the home therapy machine 100 controls the presence of a therapeutic prescription on the server. connectivity 118, as shown in block 822.  If a therapeutic prescription is present on the connectivity server 118 for the home therapy machine 100, the connectivity server 118 sends the therapeutic prescription to the home therapy machine 100, as shown in block 824.  The machine 100 asks the patient to accept the therapeutic prescription.  In one embodiment, the patient must accept the therapeutic prescription to continue using the home therapy machine 100, as shown in block 826.  In one embodiment, the therapeutic prescription downloaded from the connectivity server 118 may be a new prescription or upgrade, intended to replace a previous therapy prescription already on the machine 100.  Before the treatment begins, for example, after disinfection the previous day, the home therapy machine 100's unit ACPU 112 checks whether the connectivity service, via the agent 114, has sent a message. Therapy prescription level for this particular home therapy machine 100.  To do this, in one embodiment, the home therapy machine 100 and the set gateway 120, through the connectivity service, compare the prescription version numbers to determine whether the therapy machine to be used. home 100 has the most recent prescription.  If this is not the case, the most recent prescription version is delivered to the therapy machine 100.  The machine 100 does not perform a previous therapeutic prescription if a new therapeutic prescription has been downloaded from the connectivity server 118 and is present on the machine 100.  However, the new therapeutic prescription will not erase the old therapeutic prescription until the patient has accepted the therapeutic prescription, as shown in block 826.  In this way, the patient confirms that the patient recognizes that his treatment has been modified.  When accepting the new therapeutic prescription, the new therapeutic prescription is written in the memory of the therapy machine 100.  In an alternative embodiment, the machine 100 can store multiple therapeutic prescriptions in memory, so that even when a new therapeutic prescription is downloaded, the old therapeutic prescription is stored in memory.  The machine 100 may be able to store different types or categories of therapeutic prescriptions.  Each different type of therapeutic prescription may be a different treatment, for example, to remove a small amount, average amount, or a large amount of ultrafiltration for dialysis.  The machine 100 may be able to store a therapeutic prescription in each category.  The ACPU 112 receives the parameters and separates the parameters of the home therapy machine 100 from the parameters of the water treatment device 10 and sends the water treatment device parameters 10 on the digital link 32 to the device. water treatment 10, as shown in block 827.  The parameters may be marked as intended for the home therapy machine or the water treatment device 10.  Alternatively, the ACPU 112 may identify characteristics on the parameters as inherent to the water treatment device 10 and transmit these parameters to the water treatment device 10.  The next time the patient is ready to implement the processing, the connectivity agent 114 is disabled, as shown in block 828.  The home therapy machine 100, as shown in block 830, is now performing treatment using the therapeutic prescription specified in blocks 808 and / or 810.  The home therapy machine 100 writes the processing data produced by the processing on the log files, as shown in block 832.  Again, the log files document relevant home therapy machine data 100 and relevant water treatment device data during processing.  In one embodiment, the water treatment device 10 sends its own log files to the home therapy machine 100.  The home therapy machine 100 joins the data of the water treatment device 10 to the log files of the home therapy machine 100.  The next instant the connectivity agent 114 is enabled, the mixed log files stored in the home therapy machine 100 are sent to the connectivity server 118.  The connectivity agent 114 is activated, as shown in block 834.  In one embodiment, the home therapy machine 100 initiates the connection to the connectivity service.  In an alternative embodiment, the connectivity service may initiate the connection to the home therapy machine 100.  In block 836, the log files are downloaded to the connectivity server 118.  The program 800 then ends as shown in the end oval block.  In one embodiment, the machine 100 may perform post-processing procedures, such as a disinfection procedure that cleans the machine and the disposable components used for processing for the next treatment.  In one embodiment, the set 110 allows activation of the connectivity agent to block 834 after processing but while the disinfection treatment is being performed.  Writing processing data to block 832 can also be performed during disinfection.  Alternatively, the home therapy machine 100 waits to write the data to block 832 or activates the connectivity agent at block 834 until the disinfection and entry of the machine 100 is completed in an inactive mode.  In the embodiment shown, since the connectivity agent 114 is disabled prior to processing and is activated again only after the processing, the set 110 does not provide real-time monitoring of the device. a treatment.  Events occurring during a processing, including alarms and alerts, are not reported immediately to the overall gateway 120.  Such information is a part of the log files that are sent to the set gateway 120 after processing.  In an alternative embodiment, the connectivity agent 114 may remain active during processing and may report information about the home therapy machine 100 and the real-time therapeutic treatment.  The software upgrade will now be described.

From time to time, the software that the ACPU 112 executes on the home therapy machine 100 and / or the software that executes the processing element and memory 24 on the water treatment device 10, which can also be called here a firmware, may need to be upgraded. The home medical device assembly 110 provides an efficient and reliable manner for upgrading the firmware that integrates the product development team 128 and the service personnel 132a-132n (FIG. 1A). ). FIG. 9 shows an exemplary method 900 for upgrading a firmware on the home therapy machine 100. When starting the process 900 at the oval starting block, a product development team 128 develops an upgrade. the micro-software level for the home therapy machine or the water treatment device 10, as shown in block 902. At block 904, the product development team 128 downloads the firmware upgrade. software to the assembly gateway 120. The service portal 130 then authorizes the maintenance manager or decision maker 134 to view and approve the upgrade. By approving the upgrade, the director 134 downloads the upgrade from the assembly gateway 120 to the connectivity server 118, as shown in block 906. In the embodiment shown in FIG. 1A, the director 134 is separate from the maintenance staff 132a-132n who is responsible for the maintenance and maintenance of the home therapy machines 100 and water treatment devices 10, and the maintenance of patient relations. The director of the maintenance personnel 134 not only has the authority to be able to finalize the sending of the upgrade to the connectivity server 118, the director 134 can also designate those of the machines 100 and / or the processing devices of the server. 10 who can receive the upgrade, if not all of the machines 100 or devices 10, and he can refuse the upgrade or send it back to the product development team. view of its optimization. Once an upgrade is allowed to reach the server 118, the service personnel 132a-132n, or certain designated members thereof, can view the firmware upgrade via the portal 130, as shown in block 908. In one embodiment, the product development team 128 downloads the firmware upgrade directly to the connectivity server 118, without going through the gateway. 120. As previously described in connection with FIG. 1A, the maintenance staff 132a-132n manage the daily relations with the patients.

Maintenance personnel 132a-132n are familiar with the patient programs and are in the best position to determine whether a patient should receive a firmware upgrade. For example, maintenance personnel 132a-132n are aware of the maintenance and activity program for home therapy machines 100 and the corresponding water treatment devices they maintain normally. If the patient's machine 100 and / or the water treatment device 10 is scheduled to quickly receive a component required for the firmware upgrade, then the service personnel 132a through 132n can wait for the new machine component is installed prior to the firmware upgrade (which may, for example, require the new component) on the home therapy machine 100 and / or the patient's water treatment device 10. Each maintenance staff member 132a to 132n selects those of his home therapy machines 100 and / or designated water treatment devices that are to receive the software upgrade, as shown in block 910. instant following the connectivity agents 114 on the selected home therapy machines 100 are activated, as shown in block 912, the connectivity server 118, waiting for the agents to be activated, sends the upgrade to the therapy machines to home 100 and / or selected water treatment devices as shown in block 914.

In one embodiment, the home therapy machines 100 and / or selected water treatment devices 10 can decide, based on parameters stored in the ACPU 112 and / or the treatment element. and memory 24, whether or not they accept the upgrade, as shown in block 916. If the home therapy machines 100 and / or water treatment devices 10 selected do not select the upgrade, process 900 is completed, as shown in block 916 and the end oval block. If any of the home therapy machines 100 and / or selected water treatment devices accept the upgrade, the corresponding patients are queried through the user interface 112 to know which they want to install the upgrade, as shown in block 918. If the patients, through the user interface 112, do not choose to upgrade the home therapy machines 100 and / or With selected water treatment devices, process 900 is completed, as shown in block 920 and the end oval block. If the patients, through the user interface 112, choose to upgrade the home therapy machines 100 and / or selected water treatment devices 10, the one or more upgrades are implemented. home therapy machines 100 inform the patients, via the user interface 112 that the software has been upgraded, as shown in block 922. Some countries impose by law obtaining patient approval prior to upgrading a patient micro-software. In one embodiment, set 110 may require that only home therapy machines 100 in countries that require patient approval ask the patient for acceptance of firmware upgrade at blocks 918 and 918. 920. Home therapy machines 100 may be allowed to retain the ability to restore an old software version for either machine 100 or device 10 or both. For example, if a firmware upgrade is corrupted, or if the firmware on a home therapy machine 100 or water treatment device 10 becomes corrupted, the home therapy machine 100, in a embodiment, is allowed to restore a previous uncorrupted software version. Alternatively, the home therapy machine 100 can not revert to a previous software version. Here, if the software is corrupted or becomes corrupt, new software is installed or the home therapy machine 100 or the water treatment device 10 is exchanged by a new home therapy machine 100 or a new treatment device of water 10.

Server-level connectivity service 118 documents all events associated with firmware upgrades, such as those of patients who have received upgrades, and those of maintenance staff 132a through 132n who have been involved. in upgrades. The connectivity server 118 stores serial numbers, tracking numbers, and software versions so that the various steps of the upgrade process are documented and so that at any given time the current software version of each machine 100 and device 10 on assembly 110 can be easily obtained. At the end oval block in Fig. 9, the method 900 is completed. As previously described, all software upgrades for the water treatment device 10 may also be sent to the water treatment device 10 via the home therapy machine 100. The Home Therapy 100 may receive a mixed software upgrade that contains software upgrades for both the home therapy machine 100 and the water treatment device 10. Or, the upgrades may be issued separately. The ACPU 112 then analyzes and separates the software content for the home therapy machine 100 from the software content for the water treatment device 10. In particular, the ACPU 112 can identify which software content is intended for the home therapy machine 100 and what software content is intended for the water treatment device 10. For example, the software content may inherently resemble or contain content that is particular to one or the other of the machine 100 or the water treatment device 10. Alternatively, the software content may be marked as being intended for the home therapy machine 100 or the water treatment device 10. The therapy machine at Home 100 then sends the software content for the water treatment device 10 over the digital link 32 to the water treatment device 10. Software upgrades may furthermore be provided. as previously described for other home-made components of the assembly 110, for example, the tablet 122, the blood pressure monitor 104 and / or the weigh scale 106. A dashboard of clinician with evaluation rule is then described. A clinician can view a list of clinician patients and a file for each patient showing how the treatments for the patients went. The treatment files are deduced from the log files on the home therapy machine 100, including the flow rates achieved, the ultrafiltrate removal, the ultrafiltration rates achieved, the blood pressure during therapy, the weight, etc. The log files may also include processing data for the water treatment device 10 as previously described. The process data stored for the water treatment device 10 may, for example, comprise a total volume of purified water delivered, an average water temperature, an average water pressure, a number of supply requests from the machine 100, alarms and alarm information, chlorine / chloramine levels, and / or component usage or replacement information. A clinician can sort the following patient list into a number of categories, including the type of treatment they have received, for example, hemodialysis (subdivided, for example, into a daily, night, every other day, and a night). out of two), peritoneal dialysis (subdivided, for example, into continuous cycle peritoneal dialysis ("CCPD"), cyclic), the supervising physician, or according to the notifications described below. A clinician can also view a patient snapshot and a summary for the week, month or other duration. Internet Portal 150 provides a clinician dashboard that provides notifications of events that occurred during treatment. In one embodiment, the notifications include color indicia, with different colors corresponding to different notification conditions. Clinicians can choose events that generate the red or yellow indicators that appear on the dashboard. In one embodiment, the indicator settings are clinic specific, not patient specific. Thus, the choice to receive notification regarding certain events applies to all patients in the clinic or in the case of the clinician. For example, a clinician might define a rule so that a yellow flag should appear on the dashboard if a treatment lasted less than four hours. This rule should apply to all patients in this clinic or in the case of this clinician. The dashboard shows, for example, with yellow indicators, all patients who have undergone treatment that lasted less than four hours. The indicators may also relate to the water treatment device 10, for example, to edit an indicator when a disposable component of the water treatment device 10 has less than ten hours of life, or to edit a red indicator if the chlorine / chloramine tests reach a certain level.

FIG. 10A shows an exemplary dashboard screen 1000 for a clinic on a clinician display device 192. The dashboard display 1000 is, in one embodiment, the first screen that a clinician sees when it connects to the Internet portal 150. The dashboard screen 1000 provides a general view of the information about the patients managed by this clinic, as well as the manner in which the treatments are implemented by the patient. home therapy machine 100 and the water treatment device 10. The patients are listed by name as shown in column 1002. The dashboard 1000 may allow the clinician to apply filters as shown by For example, the clinician in the illustrated embodiment may filter the information on the dashboard by type of patient (not shown), by physician from drop-down menu 1012, or depending on the condition of a patient (not shown). The clinician can also filter the information on the dashboard to show only treatments for which there was no communication using the control box 1014, or to show only the treatments for which an indicator was produced using the control box 1016. The filters allow the clinician to refine a particular desired information. Different icons 1004, 1006, and 1008 represent information about a treatment performed by a patient on a specific date. Icons 1004, 1006, and 1008 can represent different types of events. For example, the icon 1004 may be used to represent that a processing performed on the home therapy machine 100 and the water treatment device 10 has been successfully performed. The 1006 icon can be used to notify the clinician of events that are not critical and do not require immediate action, but require close monitoring in the future. The icon 1008 may, for example, be used to notify the clinician of events that require immediate action. A user can access a legend using link 1018. When a user selects link 1018, a pop-up window or a new screen 1050 appears. Fig. 10B shows an example of a legend screen 1050 on a clinician display device 192 that explains the different icons that may appear on the dashboard display 1000. The icon 1004 represents that the processing executed by the 100 home therapy machine and 10 water treatment device ran "correctly". The 1008 icon represents a high priority indicator. The 1006 icon represents a normal priority indicator. The icon 1010 represents that there has been no communication with the home therapy machine 100 associated with this patient for a specific treatment. In one embodiment, the dashboard also displays information collected by the water treatment device 10 in the log files of the water treatment device 10. Fig. 11A shows an example of a treatment summary screen 1100, which is a part of the clinician dashboard or is accessible via a link from the dashboard, on the clinician display device 192. The treatment summary screen 1100 presents partial details of a particular treatment performed on a patient by a home therapy machine 110 and a water treatment device 10 as collected in the log files as previously described. Fig. 11A shows information regarding a treatment performed by a home therapy machine 100 and a water treatment device 10 on July 31, 2010, as shown in Table 1102. From the summary screen of 1100, a clinician can see a description of the indicator symbols in Table 1101. The clinician can also see the date, start time, and total dialysis time in Table 1102, the device schedule prescribed on the chart. Table 1104 and the overall processing summary log on a table format showing the exact times of different processing events for the home therapy machine 100 and / or the water treatment device 10 on the table 1106. The screen Processing summary 1100 also indicates information collected from the water treatment device 10. For example, item 1107 in table 1106 tells a clinician that the device Water Treatment 10 recorded a cold water alert at the time of 20:41:13. Any of the alerts or events documented in the log files and displayed on the clinician dashboard may also have been communicated to the user 12 via the user interface 122 during the therapy, at the time the alert or event occurred. The screen 1100, shown on a clinician display device 192, continues in Fig. 11B. As shown in Fig. 11B, a clinician can view fluid management information in Table 1108, information about the treatment dose on Table 1110, heparin information on Table 1112, data from extensive use of dialyzer in Table 1114, blood pressure in Table 1116, and pulse information in Table 1118. A clinician can also view information about pre-treatment samples taken for comparative purposes on the chart 1120, including the time 1121 at which the water sample was taken from the water treatment device 10. A clinician may also view details of the device program prescribed in Table 1122. The clinician may also view the device ID of the home therapy machine 100 and the software versions of the therapy machine Figure 12 illustrates an example of a patient use report 1200 that can be presented to a clinician at an Internet portal 150 on the device. The example 1200 patient usage report allows a clinician to view the amount of product or consumables used by the home therapy machine 100 and the current water treatment device 10. the treatment of a specific patient over a specified time period. On the 1200 patient utilization report, the clinician can view the treatment month 1202 as well as the information relating to the use of the home therapy machine 100, such as the dialyzer used 1204, the set of used blood treatment 1206, the acid concentrate used 1208 and the bicarbonate concentrate used 1210. The clinician can also view information relating to the use of the water treatment device 10, such as the pre-filters of used 1212 and the water distribution loop used 1214. Thus, the clinician can view information regarding the use of consumables on one or more treatments that relate to the home therapy machine 100 as well as the water treatment device 10.

Additional Aspects of the Present Invention Certain aspects of the contents of the present invention described herein may be used alone or in combination with any one or more of the other aspects described herein. Without limiting the foregoing description, according to a first aspect of the present invention, a home medical device assembly includes a home therapy machine for performing home therapy on a patient; a user interface operably connected to the home therapy machine, the user interface receiving operator inputs; a water treatment device in fluid communication with the home therapy machine; and a digital link between the home therapy machine and the water treatment device, wherein the home therapy machine transmits data via the linkage to the water treatment device so that controlling the water treatment device, the data being delivered on the basis of at least one of the operator inputs received via the user interface. According to a second aspect of the present invention, which may be used in combination with any one or more of the foregoing aspects, the water treatment device transmits to the home therapy machine at least one of: ) status information, (ii) component lifetime information, (iii) self-test results, (iv) alert information, or (v) version information.

According to a third aspect of the present invention, which may be used in combination with any one or more of the foregoing aspects, the user interface displays at least one of: (i) status information, ( ii) component lifetime information, (iii) self-test results, (iv) alert information, or (v) version information.

According to a fourth aspect of the present invention, which may be used in combination with any one or more of the foregoing aspects, the home therapy machine transmits to the water treatment device at least one of; (i) status change requests, (ii) status requests, (iii) rate change requests, (iv) software upgrades or restorations, or (y) file transfers. According to a fifth aspect of the present invention, which may be used in combination with any one or more of the preceding aspects, wherein the user interface displays at least one of: (i) requests for change of status, (ii) status requests, (iii) rate change requests, (iv) software upgrades or restorations, or (v) file transfers. According to a sixth aspect of the present invention, which may be used in combination with any one or more of the foregoing aspects, the operator data (s) lead to transmitted data relating to a water treatment device parameter. According to a seventh aspect of the present invention, which may be used in association with any one or more of the foregoing aspects, the one or more operator inputs leading to the transmitted data relate to a home therapy machine parameter, the data transmitted an automatic result of a change on the home therapy machine parameter.

According to an eighth aspect of the present invention, which may be used in combination with any one or more of the foregoing aspects, a home therapy medical system includes a home therapy machine for performing home therapy on a patient. ; a user interface operably connected to the home therapy machine, the user interface receiving operator inputs; a water treatment device in fluid communication with the home therapy machine; a server in digital communication link with the home therapy machine; and a digital link between the home therapy machine and the water treatment device, wherein the home therapy machine transmits data via the link to the water treatment device, the data being based on a therapeutic prescription sent from the server to the home therapy machine. According to a ninth aspect of the present invention, which may be used in combination with any one or more of the foregoing aspects, the transmitted data is for controlling the water treatment device. According to a tenth aspect of the present invention, which may be used in combination with any one or more of the foregoing aspects, the therapeutic prescription specifies the data transmitted by the home therapy machine to the water treatment device.

According to an eleventh aspect of the present invention, which may be used in combination with any one or more of the preceding aspects, the therapeutic prescription specifies an operational parameter for the home therapy machine, the transmitted data being based on the operational parameter specified.

According to a twelfth aspect of the present invention, which may be used in combination with any one or more of the foregoing aspects, the home therapy machine determines the transmitted data on the basis of the specified operational parameter. According to a thirteenth aspect of the present invention, which may be used in combination with any one or more of the preceding aspects, the water treatment device 5 uses the data to determine a corresponding operational parameter for the treatment device. 'water. According to a fourteenth aspect of the present invention, which may be used in combination with any one or more of the preceding aspects, the server is configured to send a software upgrade to the home therapy machine, if the software upgrade is intended for the water treatment device it is transmitted by the home therapy machine to the water treatment device. According to a fifteenth aspect of the present invention, which may be used in combination with any one or more of the foregoing aspects, the software upgrade is automatically installed on the water treatment device or installed upon acceptance. by a user through the user interface. According to a sixteenth aspect of the present invention, which may be used in conjunction with any one or more of the preceding aspects, the server 20 is in digital communication with a service computer, the service computer enabling a service person accessing the water treatment device via the digital link with the home therapy machine to perform at least one service procedure. According to a seventeenth aspect of the present invention, which may be used in combination with any one or more of the foregoing aspects, upon start-up, the home therapy machine is configured to determine whether the treatment device of the present invention is in use. water is in hibernation mode and if so, to perform a start-up procedure not involving the water treatment device. According to an eighteenth aspect of the present invention, which may be used in combination with any one or more of the foregoing aspects, the home therapy medical system is configured to allow a user to access the intermediate of the user interface to perform at least one self-test for the home therapy machine and at least one self-test for the water treatment device.

According to a nineteenth aspect of the present invention, which may be used in combination with any one or more of the foregoing aspects, a home therapy medical system includes a home therapy machine for performing home therapy on a patient ; a user interface operably connected to the home therapy machine, the user interface receiving operator inputs; a water treatment device in fluid communication with the home therapy machine; a server in digital communication link with the home therapy machine; and a digital link device between the home therapy machine and the water treatment device, wherein the water treatment device is configured to transmit data via the digital link to the water machine. home therapy, which transmits the data to the server. According to a twentieth aspect of the present invention, which may be used in combination with any one or more of the foregoing aspects, the transmitted data includes processing log file data. According to a twenty-first aspect of the present invention, which may be used in combination with any one or more of the preceding aspects, the transmitted data includes component utilization or component replacement data. According to a twenty-second aspect of the present invention, any of the structures and functionality shown and described in connection with FIG. 1 may be used in combination with any one or more of the foregoing aspects. According to a twenty-third aspect of the present invention, any of the structures and functionality shown and described in connection with FIG. 1A may be used in combination with any one or more of the foregoing aspects. According to a twenty-fourth aspect of the present invention, any of the structures and functionality shown and described in connection with FIG. 2 may be used in combination with any one or more of the foregoing aspects. According to a twenty-fifth aspect of the present invention, any of the structures and functionality shown and described in connection with FIG. 3 may be used in combination with any one or more of the foregoing aspects.

According to a twenty-sixth aspect of the present invention, any of the structures and functionality shown and described in connection with FIG. 4 may be used in combination with any one or more of the foregoing aspects. According to a twenty-seventh aspect of the present invention, any of the structures and functionality shown and described in connection with FIG. 5 may be used in conjunction with any one or more of the foregoing aspects. According to a twenty-eighth aspect of the present invention, any of the structures and functionality shown and described in connection with FIG. 6 may be used in combination with any one or more of the foregoing aspects. According to a twenty-ninth aspect of the present invention, any of the structures and functionality shown and described in connection with FIG. 7 may be used in combination with any one or more of the foregoing aspects. According to a thirtieth aspect of the present invention, any of the structure and functionality shown and described in connection with FIG. 8 may be used in combination with any one or more of the foregoing aspects.

According to a thirty-first aspect of the present invention, any of the structures and functionality shown and described in connection with FIG. 9 may be used in combination with any one or more of the foregoing aspects. According to a thirty-second aspect of the present invention, any of the structures and functionality shown and described in connection with FIG. 10A may be used in combination with any one or more of the foregoing aspects. According to a thirty-third aspect of the present invention, any of the structures and functionality shown and described in connection with Fig. 10B may be used in combination with any one or more of the foregoing aspects. According to a thirty-fourth aspect of the present invention, any of the structures and functionality shown and described in connection with Fig. 11A may be used in conjunction with any one or more of the foregoing aspects.

According to a thirty-fifth aspect of the present invention, any of the structures and functionality shown and described in connection with Fig. 11B may be used in combination with any one or more of the foregoing aspects. According to a thirty-sixth aspect of the present invention, any of the structures and functionality shown and described in connection with Fig. 12 may be used in conjunction with any one or more of the foregoing aspects. It should be understood that various changes and modifications to the presently preferred embodiments described above will become apparent to those skilled in the art. Such changes and modifications can be made without departing from the spirit and scope of the present invention and without diminishing its expected benefits. It must, therefore, be considered that such changes and modifications are covered by the present invention. 30

Claims (21)

REVENDICATIONS1. A home medical device kit (110) comprising: a home therapy machine (100) for performing home therapy on a patient; a user interface (122) operably connected to the home therapy machine (100), the user interface (122) receiving operator inputs; a water treatment device (10) in fluid communication with the home therapy machine (100); and a digital link (32) between the home therapy machine (100) and the water treatment device (10), wherein the home therapy machine (100) transmits data via the link (32) to the water treatment device (10) for controlling the water treatment device, the data being delivered on the basis of at least one of the operator inputs received by the intermediate user interface (122). The home medical device assembly according to claim 1, wherein the water treatment device (10) transmits to the home therapy machine (100) at least one of: (i) information from state, (ii) component lifetime information, (iii) self-test results, (iv) alert information, or (v) version information. The home medical device assembly of claim 2, wherein the user interface (122) displays at least one of: (i) status information, (ii) lifetime information component, (iii) self-test results, (iv) alert information or (v) version information. The home medical device assembly of claim 1, wherein the home therapy machine (100) transmits to the water treatment device (10) at least one of; (i) change of state requests, (ii) status requests, (iii) rate change requests, (iv) software upgrades or restorations, or (v) transfers file. The home medical device kit according to claim 4, wherein the user interface (122) displays at least one of: (i) status change requests, (ii) requests for status, (iii) rate change requests, (iv) software upgrades or restorations, or (v) file transfers. The home medical device assembly of claim 1, wherein the one or more operator data leads to transmitted data relating to a water treatment device parameter (10). The home medical device set according to claim 1, wherein the one or more operator inputs leading to the transmitted data relate to a home therapy machine parameter (100), the data transmitted an automatic result of a change on the home therapy machine parameter (100). A medical home therapy system comprising: a home therapy machine (100) for performing home therapy on a patient; a user interface (122) operably connected to the home therapy machine (100), the user interface (122) receiving operator inputs; a water treatment device (10) in fluid communication with the home therapy machine (100); a server (118) in digital communication link with the home therapy machine (100); and a digital link between the home therapy machine (100) and the water treatment device (10), wherein the home therapy machine transmits data via the link to the treatment device of the water (10), the data being based on a therapeutic prescription sent from the server (118) to the home therapy machine (100). The medical home therapy system of claim 8, wherein the transmitted data is for controlling the water treatment device (10). The medical home therapy system of claim 8, wherein the therapeutic prescription specifies the data transmitted by the home therapy machine to the water treatment device (10). The medical home therapy system of claim 8, wherein the therapeutic prescription specifies an operational parameter for the home therapy machine (100), the transmitted data being based on the specified operational parameter. The home therapy medical system of claim 11, wherein the home therapy machine (100) determines the transmitted data based on the specified operational parameter. The medical home therapy system of claim 11, wherein the water treatment device (10) uses the data to determine a corresponding operational parameter for the water treatment device (10). The medical home therapy system of claim 8, wherein the server (118) is configured to send a software upgrade to the home therapy machine (100), if the software upgrade is intended at the water treatment device (10) it is transmitted by the home therapy machine (100) to the water treatment device (10). The medical home therapy system of claim 14, wherein the software upgrade is automatically installed on the water treatment device (10) or installed upon acceptance by a user via the water treatment device (10). user interface (122). 25 The medical home therapy system of claim 8, wherein the server (118) is in digital communication with a service computer, the service computer allowing a service person to access the treatment device of water (10) via the digital link with the home therapy machine (100) to perform at least one service procedure. The medical home therapy system of claim 8, wherein upon start-up, the home therapy machine (100) is configured to determine whether the water treatment device (10) is in a mode. and, if so, to perform a start-up procedure that does not involve the water treatment device. The medical home therapy system of claim 8, which is configured to allow a user through the user interface (122) to perform at least one self-test for the therapy machine. at home (100) and at least self-test for the water treatment device (10). A medical home therapy system comprising: a home therapy machine (100) for performing home therapy on a patient; a user interface (122) operably connected to the home therapy machine (100), the user interface (122) receiving operator inputs; a water treatment device (10) in fluid communication with the home therapy machine (100); a server (118) in digital communication link with the home therapy machine (100); and a digital link device between the home therapy machine (100) and the water treatment device (10), wherein the water treatment device (10) is configured to transmit data through the intermediate digital link to the home therapy machine (100), which transmits the data to the server. The medical home therapy system of claim 19, wherein the transmitted data includes processing log file data. The medical home therapy system of claim 19, wherein the transmitted data includes component utilization or component replacement data.