A processor of a medical device configured to communicate with a remote server can be programmed to protect the medical device from exposure to unauthorized or malicious software. A system or method to implement this form of protection can include, for example, at least one processor on the medical device, a control software module that controls the operation of the medical device and is executable on the processor, a data management module that manages data flow to and from the control software module from sources external to the medical device, and an agent module that has access to a limited number of designated memory locations in the medical device. In addition, a hemodialysis apparatus can be configured to operate in conjunction with an apparatus for providing purified water from a source such as a municipal water supply or a well. A system for controlling delivery of purified water to the hemodialysis apparatus can comprise a therapy controller of the hemodialysis apparatus configured to communicate with a controller of a water purification device, and a user interface controller of the hemodialysis apparatus configured to communicate with the therapy controller, and to send data to and receive data from a user interface.

Dialysis systems comprising actuators that cooperate to perform dialysis functions and sensors that cooperate to monitor dialysis functions are disclosed. According to one aspect, such a hemodialysis system comprises a user interface model layer, a therapy layer, below the user interface model layer, and a machine layer below the therapy layer. The user interface model layer is configured to manage the state of a graphical user interface and receive inputs from a graphical user interface. The therapy layer is configured to run state machines that generate therapy commands based at least in part on the inputs from the graphical user interface. The machine layer is configured to provide commands for the actuators based on the therapy commands.

A hemodiafiltration system with a disposable pumping unit is disclosed. An example system includes a medical fluid pump actuator, a medical fluid heater, a blood filter and a disposable unit. The example disposable unit includes a medical fluid cassette portion including a medical fluid cassette housing configured to be operatively connected to the medical fluid pump actuator to pump medical fluid through the medical fluid cassette portion when the medical fluid cassette portion is in fluid communication with a medical fluid source. The example medical fluid cassette portion is also configured to be placed in fluid communication with the blood filter and with an extracorporeal circuit communicating with the blood filter, the fluid communication enabling hemodiafiltration to be performed. The example disposable unit also includes a heater bag configured to be placed in operable communication with the medical fluid heater and in fluid communication with the medical fluid cassette portion.

A hemodialysis machine comprising a fluid pathway for delivering a dialysate solution, wherein the fluid pathway comprises a pre-dialysis pathway and a post-dialysis pathway, a dialyser for dialysing patient's blood using the dialysate solution, the dialyser connected between the pre-dialysis pathway and the post-dialysis pathway, a first sensor system configured to sense a characteristic of the dialysate solution at a first location on the pre-dialysis pathway, a second sensor system configured to sense a characteristic of the dialysate solution at a second location on the post-dialysis pathway, and a control system configured to make a comparative analysis of the measurements taken by the first sensor and the second sensor for monitoring the composition of the dialysate solution.

A cassette integrated system. The cassette integrated system includes a mixing cassette, a balancing cassette, a middle cassette fluidly connected to the mixing cassette and the balancing cassette and at least one pod. The mixing cassette is fluidly connected to the middle cassette by at least one fluid line and the middle cassette is fluidly connected to the balancing cassette by at least one fluid line. The at least one pod is connected to at least two of the cassettes wherein the pod is located in an area between the cassettes.

A fluid-handling cassette comprising a plurality of diaphragm valves and pumps is configured to have its actuation ports located along a thin or narrow edge of the cassette. Actuation channels within the cassette lead from the actuation ports to actuation chambers of the valves and pumps in a space between plates that comprise the cassette. The individual plates have a nominal thickness that is sufficient to provide a rigid ceiling for the actuation channels, but sufficiently thin to minimize the overall thickness of the cassette. The cassette can be plugged into or unplugged from an actuation receptacle or a manifold by its narrow edge. A plurality of such cassettes can be stacked together or spaced apart from each other to form a cassette assembly, providing for a convenient way to install and remove the cassette assembly from its actuation receptacle. The arrangement allows for an improved way of connecting a complex cassette assembly to its associated pressure distribution manifold without the use of a plurality of flexible connecting tubes between the two.

Dialysis systems comprising actuators that cooperate to perform dialysis functions and sensors that cooperate to monitor dialysis functions are disclosed. According to one aspect, such a hemodialysis system comprises a user interface model layer, a therapy layer, below the user interface model layer, and a machine layer below the therapy layer. The user interface model layer is configured to manage the state of a graphical user interface and receive inputs from a graphical user interface. The therapy layer is configured to run state machines that generate therapy commands based at least in part on the inputs from the graphical user interface. The machine layer is configured to provide commands for the actuators based on the therapy commands.

A fluid handling cassette, such as that useable with an automated peritoneal dialysis (APD) cycler device or other infusion apparatus, may include a generally planar body having at least one pump chamber formed as a depression in a first side of the body and a plurality of flowpaths for a fluid that includes a channel. A patient line port may be arranged for connection to a patient line and be in fluid communication with the at least one pump chamber via at least a first one of said flowpaths, and an optional membrane may be attached to the first side of the body over the at least one pump chamber. In one embodiment, the membrane may have a pump chamber portion with an unstressed shape that generally conforms to the depression of the at least one pump chamber in the body and is arranged to be movable for movement of the fluid in a useable space of the at least one pump chamber. One or more spacers may be provided in the at least one pump chamber to prevent the membrane from contacting an inner wall of the at least one pump chamber. The patient line, a drain line, and/or a heater bag line may be positioned to be separately occludable in relation to one or more solution lines that are connectable to the cassette.

An improved valve leak detection system. The improved valve leak detection system comprises a membrane pump defining a flow path arranged to be opened and closed by at least one valve, a measuring device, a comparator, and a signal generator. The measuring device is configured to determine a conductivity value between two points on the flow path of the membrane pump, one point arranged upstream of the at least one valve and the other point arranged downstream of the at least one valve. The measuring device measures the conductivity value when the at least one valve is closed. The comparator is configured to continuously monitor the conductivity value. The signal generator is arranged to provide an output signal when the conductivity value is indicative of a valve leak condition for a set number of measurements within a set period of time.

A dialysis fluid system includes a dialysis fluid inlet; a dialysis fluid outlet; a pump positioned and arranged to pump dialysis fluid through the dialysis fluid inlet and the dialysis fluid outlet; and an inductive heater located between the dialysis fluid inlet and the dialysis fluid outlet, the inductive heater including a fluid flowpath positioned and arranged to receive non-heated dialysis fluid from the dialysis fluid inlet and to output heated dialysis fluid to the a dialysis fluid outlet, a conductive heater element located within the fluid flowpath so as to be or act as a secondary coil of a transformer, and a primary coil of the transformer located outside of the fluid flowpath and positioned so as to magnetically induce a current into the conductive heater element, causing the conductive heater element and surrounding fluid to heat.