Abstract: The present disclosure relates to an apparatus used in the production of a sterilizing filter for dead-end filtration of medical liquids which comprises a plurality of microporous hollow fiber membranes having a large inner diameter, and to a process for operating the apparatus.

Abstract: A medical device comprises a software (SW) system for execution by processor(s). The SW system defines a plurality of subsystems, including a primary subsystem and one or more secondary subsystems, and each subsystem comprises SW applications involved in the operation of the medical device during a medical procedure. A deterministic and distributed startup of the SW system is enabled by separating the startup procedure into a preparation for startup on a subsystem level, by use of two different notifications, and a preparation for startup on a system level, in which the primary subsystem coordinates startup of the subsystems.

Abstract: A peritoneal dialysis system includes a water purifier, a cycler, and a disposable set operable with the cycler. The disposable set includes a pumping cassette including a water inlet port, a heater/mixing container in fluid communication with the pumping cassette, a water accumulator, a first water line segment, and a second water line segment. The first water line segment is in fluid communication with the water inlet port and the water accumulator. Additionally, the second water line segment is in fluid communication with the water accumulator and the water purifier.

Abstract: An apparatus for extracorporeal treatment of blood (1) comprising a treatment unit (2), a blood withdrawal line (6), a blood return line (7), a preparation line (19) and a spent dialysate line (13); a non-invasive blood volume sensor (50) for determining an additional property of blood is active on a tube segment (61) of the blood withdrawal line or of the blood return line; the sensor includes one source (53) for directing a signal towards the blood, a plurality of detectors (57) for receiving the signal, and a controller (65) receiving the output signals from the detectors (57) and determining a blood volume variation and a value of sodium concentration in the blood (Napl) both based on the output signals. A process of determining at least one parameter and on property of blood circulating an extracorporeal blood circuit is also disclosed.

Abstract: A tube for a peristaltic pump comprises an elastically deformable tubular body (2) made from a PVC composition containing: 100 phr of a PVC resin having a K value, measured according to standard ISO 1628-2, of not less than 85, from 40 to 100 phr of DEHA plasticizer, from 0.05 to 1.0 phr of lubricant, from 0.3 to 15.0 phr of stabilizer and co-stabilizer. The deformable tube, which is usefully employed for liquid transport in a dialysis apparatus, enables a high level of fluid transport efficiency to be maintained, even after many hours of peristaltic pump operation.

Abstract: An extracorporeal blood treatment apparatus, comprises: at least a pressure sensor (24, 25) located in a respective measurement site on an extracorporeal blood circuit (6, 7); an electronic control unit (23) operatively connected at least to the pressure sensor (24, 25). The electronic control unit (23) is configured to perform at least the following procedure: receiving from the pressure sensor (24, 25) a signal correlated to a measured blood pressure (P1measured, P2measured) in the measurement site; correcting the blood measured pressure (P1measured, P2measured) through a mathematical correction model to obtain a blood actual pressure (Pinlet, Poutlet) in a reference site other than the measurement site. Between the reference site and the measurement site, a circuit section and, optionally, at least one additional device (18, 27, 28) is/are positioned. The mathematical correction model is a model of a pressure drop in the circuit section and, optionally, in the additional device (18, 27, 28).

Abstract: A device for determining the access flow rate of a patient when connected to a blood treatment machine performs a measurement phase (40), in which the blood treatment machine is caused (41, 43) to operate in first and second operating states, wherein the second operating state at least differs from the first operating state by a change of flow direction of blood or treatment fluid through a dialyzer of the blood treatment machine. Based on sensor values representing a fluid property (42, 44) of the treatment fluid in the first and second operating states, the device computes (45) a measurement value of comparison parameter (e.g. a ratio or a difference) that compares treatment efficiency in the first operating state to treatment efficiency in the second operating state, and determines (46), based on the measurement value, an estimated value of the access flow rate.

Abstract: A digital communication module for a self-contained medical device communication platform is disclosed herein. In an example, a digital communication module is communicatively coupled to a therapy module of a medical device for relaying medical device data to an electronic medical record (“EMR”) server that is connected to a medical network. The digital communication module is connected to at least one other digital communication module via a wireless proprietary network that is separate from the medical network. The digital communication module determines that the medical device data from the medical device is to be transmitted, via the wireless proprietary network, to one of the other digital communication modules that is connected to the EMR server via the medical network. The other of the digital communication modules receives, and then routes the medical device data to the EMR server via the medical network.

Abstract: A system and a method for renal replacement therapy includes a blood treatment unit connected to a blood circuit and a dialysis fluid circuit, the system further including a control unit configured to control the system according to control instructions during a treatment, so as to determine a system parameter value and an indication of membrane fouling of the membrane, and activate an automatic anti-fouling measure that includes a temporary change of the flow rate in the blood circuit and a temporary decrease of the ultrafiltration rate wherein a timing of the temporary change and a timing of the temporary reduction are synchronized.

Abstract: The exemplary systems and methods may generate treatment records for extracorporeal blood treatments. The treatment records may include a plurality of values of various parameters. The various parameters may include a compulsory set of parameters that are preset, a dependent set of parameters that a dependent on one or more of a selected treatment and a system configuration, and a discretionary set of parameters that are selected by a user.

Abstract: The present disclosure relates to a system comprising a filtration and/or diffusion device and an editable dataset comprising data pertaining to the filtration and/or diffusion device.

Abstract: A warming unit (21) coupled or configured to be coupled to a heated portion (19) of a fluid circuit (6, 7, 10, 11, 13, 14, 15; 107) of a medical device (1, 100). The warming unit (21) comprises a leakage current reduction circuit (35) configured to perform the following procedure: connecting a heat transfer element (22) of the warming unit (21) to a ground connection (33) through a resistance element (34), which keeps a normal condition patient leakage current below a first limit value, and disconnecting the heat transfer element (22) from the ground connection (33) if a current indicating that a patient is connected to a mains voltage is sensed through the resistance element (34), in order to keep a fault condition patient leakage current below a second limit value.

Abstract: An apparatus (1) for CRRT is provided comprising a blood circuit (10, 20, 30, 60) with a blood removal line (20), a treatment unit (10), and a blood return line (30). A replacement fluid container (78) is configured for containing a medical fluid, a pre-infusion line (70) has a first end (70-1) connected to the replacement fluid container (78) and a second end (70-2) connected to the blood removal line (20) and a blood pump (22) is active on the blood circuit. A replacement fluid pump (72) is active on the pre-infusion line (70), a dialysate circuit (40, 50, 70) comprises an effluent line (50) configured for discharging fluid from the second chamber, and a control unit (80) is connected to the replacement fluid pump (72) and to the blood pump (22) and is configured for performing a rinse-back procedure for restituting blood to a patient.

Abstract: Graphical user interfaces for use with extracorporeal blood treatment systems may include a plurality of mini settings cards corresponding to a plurality of settings cards. The mini settings cards may display one or more user-interactable settings, and may be selected to display the corresponding settings card. Further, each settings card may be accessed in other ways to selection of mini settings card such as, for example, by selection of a process feature graphical element corresponding the settings card.

Abstract: A CRRT apparatus comprising a filtration unit (2), a blood circuit (17), a blood pump (21), a dialysate line (13) and one or more lines (8; 51; 57; 58; 63; 69; 67; 74) to transfer a respective solution into blood; a fluid source for each of said one or more lines, wherein said solution comprises at least one buffer agent in the form of bicarbonate or bicarbonate precursor. A control unit (12) is configured to receive a patient prescription and to determine a parameter (Jbuffer_load/BW) indicative of a steady state acid-base balance in the blood of the patient who has to undergo a CRRT blood treatment, wherein said parameter is determined as a function of the concentration of said buffer agent in said fluid source and as a function of the estimated or calculated patient systemic steady state concentration of bicarbonate and/or bicarbonate precursors.

Abstract: A fluid temperature control device for an extracorporeal blood treatment apparatus, comprises: a casing (26) delimiting a heating/cooling seat (20) configured to accommodate a fluid warming bag (17) connected or connectable to an extracorporeal blood treatment apparatus (1); heating elements (29, 30) operatively active in the heating seat (20) to heat the fluid warming bag (17); at least a presence detector (32, 33) operatively active in the heating seat (20) to detect the presence of the fluid warming bag (17). The presence detector (32, 33) comprises an electromagnetic transmitter (34) and an electromagnetic receiver (35).

Abstract: An extracorporeal therapy system includes: (i) a dialysis fluid circuit including dialysis fluid preparation structure to prepare a dialysis fluid for treatment, the dialysis fluid circuit including a fresh dialysis fluid pump, a used dialysis fluid pump, and at least one filter for purifying the dialysis fluid; (ii) a blood circuit including a blood filter for use during the treatment; (iii) a blood pump operable to pump blood through the blood circuit and blood filter; (iv) a source of disinfecting fluid; and (v) a control unit operable with the dialysis fluid preparation structure and the blood pump, the control unit programmed to cause the disinfecting fluid to be delivered to and located for a duration at an area of the dialysis fluid circuit having the at least one purifying filter, and wherein during the duration the disinfecting fluid is precluded from contacting at least the fresh dialysis fluid pump.

Abstract: A peritoneal dialysis system includes a cycler including a pump actuator, a heater and a heating pan operable with the heater, and a disposable set operable with the cycler. The heating pan includes a sidewall forming a slot. The disposable set includes a pumping cassette and a heater/mixing container. The pumping cassette includes a pump chamber configured to be actuated by the pump actuator. Additionally, the heater/mixing container is in fluid communication with the pumping cassette and is sized to be received at the heating pan. The heater/mixing container includes a port configured such that when the port is slid into the slot of the heater pan sidewall, the port is prevented from rotating about an axis transverse to a direction of flow through the port.

Abstract: A control system is configured to implement a method of preparing a blood treatment apparatus (1) for blood treatment. The method comprises installing, by use of a disposable arrangement, first and second flow circuits (C1, C2) separated by a semi-permeable membrane (25), the first flow circuit (C1) being connected for fluid communication with the apparatus (1) and the second flow circuit (C2) being connected to form a closed loop that includes a sterilizing filter (46) and, optionally, a container (30). The method further comprises performing backfiltration to transfer a human-compatible fluid from the first flow circuit (C1) to the second flow circuit (C2) through the semi-permeable membrane (25), and circulating (304) the human-compatible fluid in the closed loop of second flow circuit (C2), to thereby sterilize the human-compatible fluid by the sterilizing filter (46) and, optionally, collect a resulting sterile fluid in the container (30) for later use.

Abstract: A fluid sampling or infusion device for an extracorporeal blood treatment apparatus comprises: a protective body (29) having a first aperture (30) and a second aperture (31) and comprising a connecting device (28) configured to connect, optionally in removable manner, the protective body (29) to a sampling or infusion site (20) of the extracorporeal blood treatment apparatus (1); a needle assembly (33) comprising a first end (34) connected or connectable, optionally in removable manner, to a syringe (22) and a needle (35) protruding from a second end opposite the first end (34). The needle assembly (33) is movable inside the protective body (29) between a first position and a second position. In the first position the needle (35) is completely enclosed by the protective body (29) and in the second position the needle (35) protrudes from the second aperture (31) to pierce the sampling or infusion site (20).