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.

The disclosed subject matter relates to extracorporeal blood processing or other processing of fluids. Volumetric fluid balance, a required element of many such processes, may be achieved with multiple pumps or other proportioning or balancing devices which are to some extent independent of each other. This need may arise in treatments that involve multiple fluids. Safe and secure mechanisms to ensure fluid balance in such systems are described.

A portable hemodialysis system is provided including a dialyzer, a closed loop blood flow path which transports blood from a patient to the dialyzer and back to the patient, and a closed loop dialysate flow path which transports dialysate through the dialyzer. In addition, the hemodialysis system includes two reservoirs which can be alternately placed in the dialysis flow path using various controllable fluid valves. The weight, and therefore the level of dialysate, of each reservoir is measured by a preferred level sensor having a strain measuring device which includes a load cell and a tilt sensor. The load cell and tilt sensor are electrically connected to a processor for sending force and tilt measurements to the processor. The processor may analyze the tilt measurements to correct for any inaccurate measurements of the load cell caused by the tilt.

A detector assembly configured for use in a dialysis (e.g., a hemodialysis) system is disclosed herein. The detector assembly including a wetness detector configured to detect blood, fluid, a leak, etc. The detector assembly being operatively coupled to, and more preferably, including an inertial measurement unit (IMU). Thus arranged, the detector assembly is configured to measure, read, obtain, provide, etc. additional information or data during a dialysis treatment, which information or data can be transmitted and/or used to, for example, provide greater insight into the system and/or to make better decisions. In one embodiment, the detector assembly can be used to determine when and how a patient is moving and feed that information back to the dialysis machine. In use, the information or data can be used in combination with other information to make an improved determination as to the requirement for an alert and/or stoppage of the dialysis treatment.

A system and method for monitoring the health of dialysis patients with Raman spectroscopy measurements of one or more target analytes is described. The methods include irradiating one or more fluids of interest with light to produce one or more spectrum and detecting the spectrum with a detector. The fluids of interest are preferably those related to dialysis, including hemodialysis and peritoneal dialysis. In a preferred embodiment, the fluids are irradiated with monochromatic light, and one or more Raman spectra are detected as a result of the irradiation. The fluids may be irradiated within the dialysis tubing itself, or removed from the dialysis tubing and irradiated in a separate chamber. The Raman spectra of one or more target analytes of a dialysis patient may be followed over time or compared to one or more reference spectra, thereby providing information on the health of dialysis patients.

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.

A light shield is arranged in a light shielding position with respect to a sensor or a blood leakage detector installed in a medical apparatus and monitoring for changes of transmittance in a translucent fluid carried in a tubing connected to the medical apparatus. The light shield has a non-transparent configuration and is configured to prevent environmental light from being incident on a relevant detection active sensor area. Further, a disposable kit for a medical apparatus which is arranged to be mounted to the medical apparatus and to carry pre-installed disposables to be used during a medical treatment comprises a hard-shell subassembly arranged to be positioned in a region of the medical apparatus in the vicinity of a detection active sensor area of a sensor which is sensitive to light and installed in the medical apparatus. At least one light shield element is selected from first to third light shield elements, and the at least one light shield element is mounted to the hard-shell subassembly of the disposable kit in a region where the detection active sensor area is underneath.

The specification discloses a portable dialysis machine having a detachable controller unit and base unit. The controller unit includes a door having an interior face, a housing with a panel, where the housing and panel define a recessed region configured to receive the interior face of the door, and a manifold receiver fixedly attached to the panel. The base unit has a planar surface for receiving a container of fluid, a scale integrated with the planar surface, a heater in thermal communication with the planar surface, and a sodium sensor in electromagnetic communication with the planar surface. Embodiments of the disclosed portable dialysis system have improved structural and functional features, including improved modularity, ease of use, and safety features.

The invention relates to a blood treatment device comprising an attachment unit 7 for attaching a functional unit 1 intended for single use for carrying out the blood treatment. The blood treatment device according to the invention is characterised by a monitoring unit 8 for monitoring the operability and/or the operating state of the functional unit 1, which functional unit comprises at least one light transmitter 17A, 18A and at least one light receiver 17B, 18B. The light transmitter and light receiver are arranged in the monitoring unit 8 according to the invention on one side of the functional unit 1. The arrangement of the light transmitter and light receiver on the same side has the advantage that the monitoring unit 8 can be integrated into the attachment unit 7 of the blood treatment device without any major structural modifications. The monitoring of the functional unit 1 is based on an optical measurement method in which the light reflected on a part of the functional unit 1 or a part of the attachment unit 7 is detected. A calculation- and evaluation unit 13 is configured such that conclusions can be drawn as to a defective state and/or a certain operating state of the functional unit 1 based on the intensity of the light falling on the functional unit and the light reflected on the functional unit or the attachment unit.

A disposable cartridge for use in a hemodialysis machine has a blood flow path for carrying a volume of blood to be treated in a dialyser and a dialysate flow path, isolated from the blood flow path, for delivering a flow of dialysate solution through the dialyser. The cartridge is received in an engine section of the machine. The engine section has first and second platens which close when the cartridge is inserted to retain the cartridge. Actuators and sensors arranged on the second platen control operation of the cartridge.