Method and system for providing configuration parameter values ​​to a medical device - Patents.com

Abstract

A method and associated system for providing configuration parameter values ​​to a medical device performing a medical procedure, the method including a remote procedure including the steps of providing a remote device with a user interface and inputting the configuration parameter values ​​to the remote device by the user interface, the configuration parameter values ​​defining a configuration of the medical device and being associated with an identified patient and being part of a patient prescription for the identified patient. The remote procedure further includes generating a configuration signal encoding the configuration parameter value. The method further includes an acquisition procedure including providing a reader to the medical device, reading the configuration signal by bringing the reader of the medical device relatively close to the remote device, and acquiring the configuration parameter value via the reading step. The medical device is configured based on the configuration parameter value.

Description

[Technical field]

[0001] The present invention relates to a method and associated system for wirelessly providing configuration parameter values ​​to a medical device, such as an extracorporeal blood treatment machine, for use by the medical device to configure and subsequently perform a medical procedure on a patient. [Background technology]

[0002] A medical device, specifically an extracorporeal blood treatment device, is configured by an operator, such as a nurse, practitioner or clinician, to perform a proper medical treatment on a patient. Specifically in the dialysis field, some setting parameter values ​​must first be determined to define a prescription and then provided to the medical device so that the medical device operates according to the prescription. In the dialysis field, the setting parameter values ​​may include the dialysis treatment type to be performed, such as ultrafiltration treatment (UF), hemodialysis treatment (HD), hemofiltration treatment (HF), hemodiafiltration treatment (HDF), etc. Then, for each of these types of dialysis treatment, further related setting parameter values, such as fluid flow rate, treatment time and ultrafiltration rate, may need to be input. In other words, the operator needs to go to each patient and manually input the related setting parameter values ​​into the medical device. In this case, the operator needs to input the setting parameter values ​​physically through a user interface at the medical device.

[0003] Alternatively, the step of inputting the configuration parameter values ​​may be performed by using a remote device, such as a remote computer, connected to the medical device by a wired connection or a local communication net, i.e., an intranet, in which case the operator can input the configuration parameter values ​​via a user interface of the remote device.

[0004] In any case, the method and related system for providing configuration parameter values ​​to a medical device is very rigid, resulting in drawbacks that adversely affect the configuration procedure. In particular, the user interface of the medical device is updateable, but is part of the medical device, which results in rigorous re-authentication. Furthermore, when configuring the device, the user must be physically located at the medical device and therefore close to each patient in order to input the configuration parameter values ​​to the medical device.

[0005] In the alternative where the user interface is connected remotely, the operator can configure the medical device remotely, however this can have adverse effects on patient safety as the operator is not physically near the patient. Summary of the Invention

[0006] Object of the invention It is therefore an object of the present invention to at least partially overcome one or more of the drawbacks and / or limitations of the aforementioned solutions.

[0007] A first objective is to provide a flexible method and associated system for configuring medical devices.

[0008] A further object is to provide a configuration method and associated configuration system that is easy to update and modify, while simultaneously maintaining the reliability and safety of the medical device.

[0009] A subsidiary objective is to provide a configuration method and associated configuration system that allows an operator to configure medical equipment as close to a patient as quickly as possible to avoid prolonged exposure of the operator to a patient potentially affected by a contagious disease.

[0010] A secondary object is to provide a configuration method and associated configuration system that allows an operator to input configuration parameter values ​​both remotely and locally to a medical device, so that the operator can comfortably input most parameters remotely and make changes to the configuration parameter values ​​when closer to the patient.

[0011] A further ancillary object is to provide a configuration method and associated configuration system to make the configuration procedure easier, faster and safer for the operator, while simultaneously maintaining the reliability and safety of the medical device.

[0012] A further subsidiary object is to provide a configuration method and associated configuration system for making the configuration procedure more reliable by avoiding input errors in configuration parameter values.

[0013] A further object is to provide a setting method and associated setting system for chronic or acute hemodialysis (HD) treatment.

[0014] These objects, aims and many more which will become more apparent from the following description are substantially achieved by systems and methods according to one or more of the following claims and / or aspects.

[0015] A first aspect relates to a method (100) for providing configuration parameter values ​​to a medical device for performing a medical procedure, the method comprising: - providing a remote device (60) comprising a user interface (61); - inputting configuration parameter values ​​(70) into the remote device (60) by a user interface (61), the configuration parameter values ​​defining settings of the medical device and relating to an identified patient and a portion of a patient prescription (73) for the identified patient; - generating, by a signal generator, a configuration signal encoding a configuration parameter value (70), the configuration signal being variable depending on the inputted configuration parameter value and comprising at least one of an optical pattern (80) and optionally a frequency-related signal based on an NFC or Bluetooth protocol; a remote procedure that includes the steps of The method is: - providing a medical device comprising a reader (40); - reading the configuration signal by bringing the medical device reader (40) relatively close to the remote device (60) (communication systems require physical proximity to the reader); - obtaining a setting parameter value (70) via a reading step; The method further includes an acquisition procedure including the steps of The medical device is configured based on the value of the configuration parameter value.

[0016] A second aspect relates to a method for providing configuration parameter values ​​to an extracorporeal blood treatment device (1) for performing an extracorporeal blood treatment, comprising: The method is: - providing a remote device (60) comprising a user interface (61); inputting, by a user interface (61) into the remote device (60), configuration parameter values ​​(70) that define settings of the extracorporeal blood treatment device (1) and that are associated with an identified patient and that are part of a patient prescription (73) for the identified patient, the configuration parameter values ​​being: Patient Fluid Removal Rate (PFR) for the identified patient; and Two parameters for identified patients: total weight loss (WL), total treatment time (TT) and ultrafiltration flow rate (UFR); and - generating a configuration signal that is variable depending on an inputted configuration parameter value, the configuration signal encoding the configuration parameter value (70), the configuration signal comprising at least one of an optical pattern (80) and a frequency-related signal, optionally based on the NFC or Bluetooth protocol (or based on any physical proximity wireless protocol); a remote procedure that includes the steps of The method is: - providing an extracorporeal blood treatment device (1) comprising a reader (40); - reading the setting signal by bringing the reader (40) of the extracorporeal blood medical device (1) relatively close to the remote device (60); - obtaining a setting parameter value (70) via a reading step; The method further includes an acquisition procedure including the steps of The extracorporeal blood treatment device (1) is configured based on the values ​​of the set parameter values.

[0017] A third aspect relates to a method (1000) for providing configuration parameter values ​​to an extracorporeal blood treatment device (1) for performing an extracorporeal blood treatment, the method comprising: - providing a remote device (60) comprising a user interface (61); inputting setting parameter values ​​(70) via a user interface (61) into the remote device (60), the setting parameter values ​​defining settings of the extracorporeal blood treatment device (1) and being associated with an identified patient and being part of a patient prescription (73) for the identified patient, the setting parameter values ​​(70) being: Patient Fluid Removal Rate (PFR) for the identified patient; and Two parameters for identified patients: total weight loss (WL), total treatment time (TT) and ultrafiltration flow rate (UFR); and - generating an optical pattern (80) encoding set parameter values ​​(70), the optical pattern (80) being variable depending on input set parameter values; a remote procedure that includes the steps of The method is: - providing an extracorporeal blood treatment device (1) comprising a reader (40); - displaying an optical pattern (80) on a display (62); - reading the optical pattern (80) displayed on the display (62) by bringing the reader (40) of the extracorporeal blood treatment device (1) relatively close to the display (62); - obtaining a setting parameter value (70) via a reading step; The method further includes an acquisition procedure including the steps of The extracorporeal blood treatment device (1) is configured based on the values ​​of the set parameter values.

[0018] A fifth aspect relates to a system comprising a medical device (1) and a remote device (60), the medical device (1) comprising: a (proximity) reader (40) for reading the optical pattern (80) and / or the frequency-related signal, a control unit (50) connected to the reader (40); Equipped with The remote device (60) comprises a user interface (61), a signal generator, and a controller (51); enabling input of values ​​for setting parameter values ​​(70) via a user interface (61), where the setting parameter values ​​define a setting of the medical device (1) and are associated with an identified patient, and the setting parameter values ​​are part of a patient prescription (73) for the identified patient; generating, by a signal generator of the remote device (60), a configuration signal encoding a configuration parameter value (70), the configuration signal being variable depending on the input configuration parameter value and including at least one of an optical pattern (80) and, optionally, a frequency-related signal based on an NFC or Bluetooth protocol; and a controller (51) configured to: The remote device (60) is a portable device that generates a configuration signal; The control unit (50) of the medical device (1) Obtaining the set parameter value (70) by reading the optical pattern (80) via a reader (40); - configuring the medical device (1) based on the value of the configuration parameter value; It is configured as follows.

[0019] In a sixth aspect according to the previous aspect, the remote device (60) comprises both an input device (63) for inputting setting parameter values ​​and a signal generator, in particular a signal generator between a display and a frequency emitter, in particular the remote device (60) defining a single portable body.

[0020] In a seventh aspect according to the previous aspect, the setting signal is an optical pattern (80) and the acquisition procedure is Displaying an optical pattern (80) on a display (62) of a remote device (60); reading the optical pattern (80) by bringing the medical device reader (40) relatively close to the display (62) of the remote device (60); or The configuration signal is a frequency-related signal and the acquisition procedure comprises: transmitting a frequency-related signal by a frequency emitter of a remote device (60); reading the frequency related signal by bringing the medical device reader (40) relatively close to the display (62) of the remote device (60); The steps include:

[0021] In further aspect 7-2 according to any one of the previous aspects, the method includes performing a remote procedure at a remote time interval and performing an acquisition procedure at an acquisition time interval, the acquisition time interval being shorter (e.g., much shorter) than the remote time interval.

[0022] In a further aspect 7-3 according to the previous aspect, the acquisition time interval lasts between 0.1 seconds and 40 seconds, more specifically between 1 second and 20 seconds, more specifically between 2 seconds and 10 seconds.

[0023] In further aspect 7-4 according to any one of the previous two aspects, the remote time interval lasts for more than 1 minute (e.g., between 1 minute and 30 minutes), more particularly more than 1.5 minutes (e.g., between 1.5 minutes and 20 minutes), and more particularly more than 2 / 3 minutes (e.g., between 2 / 3 minutes and 5 minutes).

[0024] In a further aspect 7 of 5 according to any one of the previous three aspects, the acquisition time interval is at least 30% shorter than the remote time interval, particularly 50% shorter, more particularly 80% shorter, and more particularly 90% shorter.

[0025] In further aspect 7 of 6 according to any one of the previous four aspects, the remote time interval is defined as the average time required for a user, i.e. a doctor or a nurse, to input all setting parameters of a medical device capable of performing the associated medical procedure or an extracorporeal blood treatment device capable of performing the associated extracorporeal blood treatment.

[0026] In a further aspect 7 of any one of the previous five aspects, the acquisition time interval is defined as the time required for the control unit (50) of the device (1) to perform at least the following steps of the acquisition procedure: - reading the configuration signal by bringing the medical device reader (40) into relative proximity to the remote device (60); and - obtaining a setting parameter value (70) via a reading step; - optionally configuring the device (1) based on configuration parameter values ​​(70); It is.

[0027] An eighth aspect relates to a system comprising an extracorporeal blood treatment apparatus (1) and a remote device (60), the extracorporeal blood treatment apparatus (1) comprising: - a filtration unit (2) having a primary chamber (3) and a secondary chamber (4) separated by a semipermeable membrane (5); A blood circuit, a blood removal line (6) extending between a first end connected to the inlet of the primary chamber and a second end for connection to a patient (P); a blood return line (7) extending between a first end connected to the outlet of the primary chamber (3) and a second end for connection to a patient (P); A blood circuit comprising: a blood pump (10) for circulating blood in the blood circuit; a discharge line (12) connected to the outlet of the secondary chamber (4); a reader (40) for reading the optical pattern (80); a control unit (50) controlling the blood pump (10) and connected to the reader (40); Equipped with The remote device (60) includes a user interface (61) and a controller (51), enabling input of values ​​for setting parameter values ​​(70) via a user interface (61), where the setting parameter values ​​define settings for the extracorporeal blood treatment device (1) and are associated with an identified patient, the setting parameter values ​​being part of a patient prescription (73) for the identified patient, and the setting parameter values ​​(70) being Patient Fluid Removal Rate (PFR) for the identified patient; and Two parameters for the identified patients: total weight loss, total treatment time and ultrafiltration flow rate; At least one of generating an optical pattern (80) that encodes the set parameter values ​​(70), the optical pattern (80) being variable depending on the input set parameter values; and a controller (51) configured to: The control unit (50) of the extracorporeal blood treatment device (1) comprises: Obtaining the set parameter value (70) by reading the optical pattern (80) via a reader (40); - setting the extracorporeal blood treatment device (1) based on the value of the set parameter value; It is configured as follows.

[0028] In a ninth embodiment according to any one of the previous embodiments, the parameter of total weight loss is a function of both total treatment time and ultrafiltration flow rate, specifically WL=UFR·TT and WL=Total weight loss UFR=ultrafiltration flow rate TT = total treatment time It is.

[0029] In a tenth aspect according to any one of the previous aspects, the optical pattern (80) includes image coding information including the set parameter value (70), and specifically the image coding information includes at least one of a barcode, a QR code, and a steganographic image.

[0030] In an eleventh aspect according to any one of the previous aspects, the acquisition step includes a step of bringing a display (62) of the remote device (60) close to, in particular facing, a reader (40) of the medical device.

[0031] In a twelfth aspect according to any one of the preceding aspects, the remote device (60) is a portable device that defines a body and physically comprises both an input device (63) that allows a user to input setting parameter values ​​(70) and a display (62) that visualizes the optical pattern (80).

[0032] In a thirteenth aspect according to any one of the preceding aspects, the remote device (60) is a portable device that defines a body and physically comprises both an input device (63) that allows a user to input setting parameter values ​​(70) and an emitter for emitting a frequency-related signal.

[0033] In a fourteenth aspect according to any one of the previous aspects, the set parameter values ​​(70) include a plurality of instructions for the extracorporeal blood treatment device (1) to subsequently perform an extracorporeal blood treatment on the patient.

[0034] In a fifteenth aspect according to any one of the previous aspects, the set parameter values ​​(70) include a plurality of instructions for the medical device (1) to subsequently perform a medical procedure on a patient.

[0035] In a sixteenth aspect according to any one of the previous aspects, the set parameter values ​​(70) further include at least one of patient information (71) and a treatment configuration (72) of the extracorporeal blood treatment device (1).

[0036] In a seventeenth aspect according to any one of the previous aspects, the setting parameter values ​​(70) further include at least one of patient information (71) and a treatment configuration (72) of the medical device (1).

[0037] In an eighteenth aspect according to any one of the previous aspects, the patient information (71) includes at least one of the following information: the patient's age, the patient's weight, the patient's hematocrit value, patient identification information, the patient's gender, and the patient's associated diseases.

[0038] In a nineteenth aspect according to any one of the previous aspects, the patient information (71) includes patient identification information, in particular the patient's name or identification code.

[0039] In a twentieth embodiment according to any one of the previous embodiments, the treatment arrangement (72) comprises: - Dialysis treatment type, including one of ultrafiltration (UF), hemodialysis (HD), hemofiltration (HF), and hemodiafiltration (HDF); -Optionally indicate the dialysis treatment type, disposable fluid line set type, - dialysis filter or filter set type, indicating a dialyzer type or a disposable set including a dialyzer type, - an anticoagulation setting for the extracorporeal blood treatment device (1), in particular the anticoagulation being selected from systemic (e.g. heparin) anticoagulation and local anticoagulation, e.g. citrate anticoagulation, and -Presence or absence of blood warmer, Includes at least one of the following:

[0040] In a twenty-first aspect according to any one of the previous aspects, the treatment configuration (72) includes a dialysis treatment type including one of ultrafiltration treatment (UF), hemodialysis treatment (HD), hemofiltration treatment (HF), and hemodiafiltration treatment (HDF).

[0041] In a twenty-second embodiment according to any one of the previous embodiments, the treatment arrangement (72) includes a disposable fluid line set type, optionally indicating a dialysis treatment type.

[0042] In a twenty-third aspect according to any one of the previous aspects, the treatment arrangement (72) includes a dialysis filter or filter set type, which refers to a dialyzer type or a disposable set including a dialyzer type.

[0043] In a twenty-fourth embodiment according to any one of the preceding embodiments, the treatment configuration (72) includes an anticoagulation setting for the extracorporeal blood treatment device (1), in particular the anticoagulation being selected from systemic (e.g., heparin) anticoagulation and local anticoagulation, e.g., citrate anticoagulation.

[0044] In a twenty-fifth aspect according to any one of the previous aspects, the treatment arrangement (72) includes an indication of the presence or absence of a blood warmer.

[0045] In a twenty-sixth aspect according to any one of the preceding aspects, the patient prescription (73) includes one or more flow rate values ​​to be set in the extracorporeal blood treatment device (1), the flow rates being selected from among a blood flow rate, a pre-blood pump (PBP) flow rate, a syringe flow rate, a fresh dialysis flow rate, and a substitution flow rate; In particular, one or more flow rates of the patient prescription depend on the treatment configuration (72), for example, on the dialysis treatment type and / or the disposable fluid line set type.

[0046] In a twenty-seventh embodiment according to the previous embodiment, the flow rate values ​​include a pre-blood pump (PBP) flow rate and an unused dialysis flow rate.

[0047] In a twenty-eighth embodiment according to the previous two embodiments, the flow rate value comprises a replacement fluid flow rate.

[0048] In a 29th embodiment according to any one of the previous embodiments, the method comprises: - providing at least one disposable component for the extracorporeal blood treatment device (1) necessary for the treatment to be performed; providing the device with at least one disposable component identification code for identifying the disposable component; Further comprising: The method is: - checking the consistency between the identified disposable components and the setting parameter values ​​obtained by reading the optical image from the display; - preventing the extracorporeal blood treatment device (1) from being configured based on at least one setting parameter value if said setting parameter does not match an identified disposable component for the extracorporeal blood treatment device (1); The method further includes a consistency procedure including the steps of:

[0049] In a 30th aspect according to any one of the previous aspects, a medical device, particularly an extracorporeal blood treatment device, comprising: - receiving at least one disposable component for the extracorporeal blood treatment device (1) necessary for the treatment to be performed, - accepting at least one disposable component identification code for identifying the disposable component; It is configured as follows: The control unit (50) of the medical device comprises: - checking the consistency between the identified disposable components and the setting parameter values ​​obtained by reading the optical image from the display; - preventing the extracorporeal blood treatment device (1) from being configured based on at least one setting parameter value if said setting parameter does not match an identified disposable component for the extracorporeal blood treatment device (1); The method is configured to perform a consistency procedure including the steps of:

[0050] In a thirty-first aspect according to any one of the previous aspects, the consistency step comprises: - a reader (40) of a medical device, in particular an extracorporeal blood treatment device (1), identifies a disposable component, the identification code of at least one disposable component being in the form of a respective optical pattern (80), or For example, a frequency scanner different from the reader (40) of the medical device identifies the disposable components, and the identification code of the at least one disposable component is in the form of a frequency-related signal (e.g. an RFID tag), The method includes the step of reading the identification code by

[0051] In a thirty-second aspect according to any one of the preceding aspects, each disposable component comprises a component identifier encoding an identification code; The set parameter value (70) includes a treatment identifier indicating a dialysis treatment to be set in the extracorporeal blood treatment device (1), specifically, the dialysis treatment is one of ultrafiltration treatment (UF), hemodialysis treatment (HD), hemofiltration treatment (HF), and hemodiafiltration treatment (HDF); The matching procedure includes checking whether a component identifier of the component matches a treatment identifier of the device according to a predefined matching list, the predefined matching list being a list between a set of component identifiers and a set of treatment identifiers; Specifically, the compatibility list includes a series of identification codes indicating compatible disposable components for each dialysis treatment: ultrafiltration treatment (UF), hemodialysis treatment (HD), hemofiltration treatment (HF), and hemodiafiltration treatment (HDF).

[0052] In a thirty-third aspect according to any one of the preceding aspects, the consistency step comprises: - defining respective threshold ranges for one or more set parameter values ​​(70) based on an identification code of the component, in particular defining respective threshold ranges based on an identification code of the component, Patient Fluid Removal Rate (PFR) for the identified patient; and Two parameters for identified patients: total weight loss (WL), total treatment time (TT) and ultrafiltration flow rate (UFR); defining a threshold range for at least one of - preventing the extracorporeal blood treatment device (1) from being configured based on the setting parameter values ​​if at least one setting parameter value exceeds a respective threshold range.

[0053] In a thirty-fourth embodiment according to the previous embodiment, the respective threshold ranges refer to respective values ​​associated with at least one of the patient information (71), and the method is configured to define, or the control unit (50) of the medical device defines, threshold ranges for the patient's weight and / or age based on an identification code of a disposable component attached to the device, and the consistency procedure prevents the extracorporeal blood treatment device (1) from being configured based on the setting parameter values ​​if the patient's actual weight and / or age exceeds the respective threshold ranges.

[0054] In a thirty-fifth aspect according to any one of the preceding aspects, the setting parameter value includes patient information (71) including patient identification information, in particular a name, that identifies a patient to whom the setting parameter value relates; -associating a patient who is to undergo extracorporeal blood treatment with an extracorporeal blood treatment device (1); - providing a medical device, in particular an extracorporeal blood treatment device (1), with patient identification information from a source different from the optical pattern (80), in particular providing the extracorporeal blood treatment device (1) with the patient's name; - checking for a match between patient identification information of the set parameter values ​​read via the optical pattern (80) and identification information related to the patient provided via a source different from the optical pattern (80); - preventing the medical device (1), in particular the extracorporeal blood treatment device (1), from being configured based on the setting parameter values ​​and optionally issuing an alarm, i.e. an acoustic or visual alarm, if no match is found between the patient identification information of the setting parameter values ​​and the identification information related to the patient from the information source; The method further includes, or the control unit of the medical device is configured to execute, a cross-check procedure including the steps of:

[0055] In a thirty-sixth aspect according to any one of the previous aspects, the step of providing information related to the person to a medical device, in particular an extracorporeal blood treatment device (1), comprises: providing the patient with an identification card or an identification wearable device, for example an identification bracelet; - providing an extracorporeal blood treatment device (1) comprising a scanner, - scanning an identification card or an identification wearable device by a scanner of the extracorporeal blood treatment device (1) and providing information related to the patient's identity to a medical device, in particular to the extracorporeal blood treatment device (1); The method includes the steps of: The identification card or identification wearable device includes at least one of an optical pattern (80), such as a QR code or a barcode, and a near field communication NFC device or an RFID; Optionally, the scanner of the extracorporeal blood treatment device (1) coincides with the reader (40) of the extracorporeal blood treatment device (1).

[0056] In a thirty-seventh aspect according to the previous aspect, the medical device, in particular the extracorporeal blood treatment device, comprises a scanner configured to scan an identification card or a wearable device, for example an identification bracelet, and obtain information related to the patient's identification.

[0057] In a thirty-eighth embodiment according to any one of the previous embodiments, the remote device (60) is distinct and physically separated from the medical device or extracorporeal blood treatment device (1).

[0058] In a thirty-ninth aspect according to any one of the preceding aspects, the acquisition procedure includes a safety procedure including a step of verifying the validity of the setting parameter values ​​acquired by the optical pattern (80), specifically the safety procedure includes a step of verifying whether all the setting parameter values ​​are within a predetermined valid range, and if one or more of the setting parameter values ​​exceed the valid range, the safety procedure prevents the medical device or extracorporeal blood treatment device (1) from being configured based on the setting parameter values.

[0059] In a fortieth embodiment according to the previous embodiment, if one or more of the set parameter values ​​exceed a valid range, the safety procedure includes instructing the medical device or extracorporeal blood treatment device (1) to emit an alarm signal, such as an audible alarm signal or an alarm displayed on a display (62) of the extracorporeal blood treatment device (1).

[0060] In a fortieth aspect according to any one of the previous aspects, the acquisition step includes a verification step that is performed temporally after the step of acquiring the set parameter value (70) by reading the optical pattern (80) via the reader (40), specifically the verification step is performed by the device (1), The verification procedure is as follows: - displaying one or more of the set parameter values ​​(70) on a display, in particular on the display of the device (1); - requesting from the user an acknowledgement signal of one or more of the configuration parameter values ​​(70) received by the device (1); - checking whether an acknowledgement signal has been received; The method includes the steps of: in particular - enabling a step of configuring the extracorporeal blood treatment device (1) based on the values ​​of the configuration parameter values ​​(70) received by the device (1) if the approval signal is properly received by the device (1); - preventing the step of configuring the extracorporeal blood treatment device (1) based on the values ​​of the configuration parameter values ​​(70) received by the device if the acknowledgement signal is not properly received by the device (1);

[0061] In a fortieth aspect according to any one of the preceding aspects, the verification procedure requires the steps of: - requiring only one acknowledgement signal indicating acknowledgement of all the configuration parameter values ​​(70) received by the device (1), or - dividing the configuration parameter values ​​(70) into two or more groups containing each configuration parameter value (70) received by the device (1) and requesting an acknowledgement signal for each group of configuration parameter values ​​(70), - for each of the set parameter values ​​(70), requesting a respective acknowledgement signal indicating acknowledgement of the set parameter value (70) received by the device (1).

[0062] In a forty-fourth embodiment according to the previous embodiment, the setting parameter values ​​(70) are divided into groups based on the category of each setting parameter value, and at least a flow rate group is provided that includes only setting parameter values ​​related to flow rates for setting the extracorporeal blood treatment device (1); Optionally, an identity group is provided that includes only configuration parameter values ​​related to the patient identity; Optionally, a treatment group is provided that includes only configuration parameter values ​​associated with the treatment configuration (72).

[0063] In a fortieth embodiment according to the previous embodiment, the verifying step includes providing at least one of a flow rate group, an identification information group, and a therapy group.

[0064] In a forty-first aspect according to any one of the previous aspects, the method includes pairing the remote device (60) with the medical device or extracorporeal blood treatment device (1) based on an authentication code; - if the pairing step is successful, the method performs an acquisition step; - if the pairing step is not successful, the method prevents the acquisition procedure from being performed or the method prevents the setting parameter values ​​from being set in the extracorporeal blood treatment device (1). This allows authenticated users to perform the pairing steps, Optionally, the pairing is based on NFC or Bluetooth protocols.

[0065] In a forty-second aspect according to any one of the previous aspects, the control unit (50) of the medical device and the controller (51) of the remote device are configured to perform a step of pairing the remote device (60) with the medical device, in particular the extracorporeal blood treatment device (1), based on an authentication code, - if the pairing step is successful, the control unit (50) of the medical device and the controller (51) of the remote device perform an acquisition procedure, if the pairing step is not successful, the control unit (50) of the medical device and the controller (51) of the remote device prevent the acquisition procedure from being executed or the setting parameter values ​​from being set in the extracorporeal blood treatment device (1); This allows authenticated users to perform the pairing steps, Optionally, the pairing is based on NFC or Bluetooth protocols.

[0066] In a 43rd aspect according to any one of the previous aspects, the authentication code includes at least one of a password, a serial number, a fingerprint, and a facial recognition algorithm.

[0067] In a forty-fourth aspect according to any one of the previous aspects, the method includes, or the control unit (50) and the controller (51) are configured to pair, the remote device (60) with the medical device, in particular the extracorporeal blood treatment device (1), each time a setting parameter value is acquired and read by the reader (40).

[0068] In a forty-fifth aspect according to any one of the preceding aspects, the optical pattern (80) encoding the setting parameter values ​​further includes an authentication code for enabling pairing of the remote device (60) with an apparatus, specifically the extracorporeal blood treatment apparatus (1).

[0069] In a forty-sixth aspect according to any one of the previous aspects, a change in the input setting parameter corresponds to a change in an optical pattern (80) displayed on a user interface (61) of the remote device (60).

[0070] In a forty-seventh aspect according to any one of the preceding aspects, the remote device (60) comprises a case, a display 62, a battery, an input device (63) that allows a user to input setting parameter values, and a controller (51) operably connected to at least the display 62, the battery and the input device (63), optionally wherein the display (62) and the input device (63) define a touch screen or the input device (63) is a keyboard (e.g., the remote device can be a mobile phone or a tablet).

[0071] In a 48th aspect according to any one of the previous aspects, the acquisition procedure is performed temporally after the remote procedure.

[0072] In a forty-ninth aspect according to any one of the previous aspects, the set parameter values ​​(70) are necessary for the extracorporeal blood treatment device (1) to perform a dialysis treatment.

[0073] In a 50th aspect according to any one of the previous aspects, the set parameter values ​​(70) are necessary for the medical device (1) to perform a medical procedure.

[0074] In a 51st aspect according to any one of the preceding aspects, the remote procedure is performed at a remote distance from the patient and / or from the medical device, and the acquisition procedure is performed at an acquisition distance from the patient and / or from the medical device, the remote distance being greater than the acquisition distance, and optionally, the medical device is an extracorporeal blood treatment device.

[0075] Typically, the remote procedure is performed in a different room to the acquisition procedure.

[0076] In a fifty-second aspect according to any one of the preceding aspects, the remote procedure comprises: a safe distance for the patient and / or for the medical device, in particular a safe distance between 2 and 100 meters, in particular between 3 and 50 meters, more particularly between 4 and 20 meters; and / or - separated from the patient by a barrier, e.g., a wall, a window, a transparent wall; Executed, the barrier and / or safety distance is configured to separate the user responsible for inputting the setting parameter values ​​(70) into the remote device (60) from the patient in order to avoid the transmission of bacteria and / or viruses between the patient and the user; Optionally, the medical device is an extracorporeal blood treatment device.

[0077] In a 53rd aspect according to any one of the previous aspects, the acquisition procedure is performed near the medical device, in particular near the extracorporeal blood treatment device (1) and near the patient, and during the acquisition procedure, the user responsible for performing the acquisition procedure is at a distance of less than 10 meters, in particular less than 5 meters, more particularly less than 3 meters, and more particularly less than 1 meter from the patient.

[0078] In a fifty-fourth aspect according to any one of the previous aspects, the cross-check procedure (400) is performed with a cross-check distance substantially equal to the acquisition distance.

[0079] In a fifty-fifth aspect according to any one of the preceding aspects, the user interface (61) of the remote device (60) comprises both a display (62) and an input device (63) for inputting setting parameter values; The method comprises: inputting one or more further setting parameter values ​​(70) into the remote device (60) via a user interface (61) of the remote device (60), in particular one or more of setting parameter values ​​of at least one of the following: a patient prescription (73), a treatment configuration (72) and / or patient information (71); and / or - modifying or updating, via a user interface (61) of the remote device (60), one or more of the configuration parameter values ​​(70) entered during the remote procedure; a local step intervening in time between the remote step and the acquisition step, the local step including the steps of: A local procedure is performed by a user at a local distance from the patient and / or from the medical device, and a remote procedure is performed by a user at a remote distance from the patient and / or from the medical device, the local distance being less than the remote distance; Optionally, the local distance is less than 10 meters, particularly less than 5 meters, more particularly less than 3 meters, more particularly less than 1 meter.

[0080] In a fifty-sixth aspect according to any one of the preceding aspects, the user interface (61) of the remote device (60) comprises both a display (62) and an input device (63) for inputting setting parameter values; The controller (51) of the remote device (60) - allowing a user to input one or more further setting parameter values ​​(70) into the remote device (60) via a user interface (61) of the remote device (60), the further setting parameter values ​​in particular including one or more of setting parameter values ​​of at least one of the following: a patient prescription (73), a treatment configuration (72) and / or patient information (71); and / or - allowing a user to modify or update, via a user interface (61) of the remote device (60), one or more of the configuration parameter values ​​(70) entered during the remote procedure; a local procedure inserted in time between the remote procedure and the acquisition procedure, the local procedure comprising the steps of: A local procedure is performed by a user at a local distance from the patient and / or from the medical device, and a remote procedure is performed by a user at a remote distance from the patient and / or from the medical device, the local distance being less than the remote distance; Optionally, the local distance is less than 10 meters, particularly less than 5 meters, more particularly less than 3 meters, more particularly less than 1 meter.

[0081] In a fifty-seventh aspect according to any one of the previous aspects, the local procedure and the acquisition procedure are performed at substantially the same location, in particular at the same distance relative to the patient and / or the medical device.

[0082] In a fifty-eighth aspect according to any one of the preceding aspects, the optical pattern (80) is displayed on a display (62) of the remote device (60), and the step of displaying the optical pattern (80) on the display (62) is performed during the acquisition procedure and temporally after the remote procedure, and in particular the step of displaying the optical pattern (80) on the display (62) is dependent on successful pairing between the remote device (60) and a medical device, in particular the extracorporeal blood treatment device (1), and in particular if pairing is not successful, the method prevents the optical pattern (80) from being displayed.

[0083] In a fifty-ninth aspect according to any one of the previous aspects, the remote device (60) comprises a battery for powering the user interface (61), in particular the display (62) and the input device (63) of the user interface (61).

[0084] In a sixtieth aspect according to any one of the previous aspects, the remote device (60) is a portable device that generates a configuration signal, in particular an optical pattern and / or a frequency-related signal that encodes a configuration parameter value (70).

[0085] In a sixty-first aspect according to any one of the previous aspects, the remote device (60) comprises both an input device (63) for inputting setting parameter values ​​and a signal generator, specifically a signal generator between a display and a frequency emitter, specifically the remote device (60) defining a single portable body.

[0086] In a sixty-second aspect according to any one of the previous aspects, a controller (51) of a remote device (60) is configured to execute a remote procedure (100).

[0087] In a sixty-third aspect according to any one of the previous aspects, a control unit (50) of the medical device (1) is configured to perform an acquisition procedure (200).

[0088] In a sixty-fourth aspect according to any one of the previous aspects, the control unit (50) of the medical device (1) is configured to perform a consistency procedure (300).

[0089] In a sixty-fifth aspect according to any one of the previous aspects, the control unit (50) of the medical device (1) is configured to perform a cross-check procedure (400).

[0090] In a sixty-sixth aspect according to any one of the previous aspects, the control unit (50) of the medical device (1) is configured to execute a safety procedure (500).

[0091] In a sixty-seventh aspect according to any one of the previous aspects, the control unit (50) of the medical apparatus (1) and the controller (51) of the remote device are configured to perform a pairing procedure (600).

[0092] In a sixty-eighth aspect according to any one of the previous aspects, the controller (51) of the remote device (60) is configured to execute a local procedure (700).

[0093] In a sixty-ninth aspect according to any one of the previous aspects, the step of displaying the optical pattern (80) on the display (62) of the remote device (60) is part of a remote procedure or an acquisition procedure.

[0094] In a seventieth aspect according to any one of the previous aspects, a controller (51) of the remote device (60) is configured to perform a step of displaying an optical pattern (80) on a display (62) of the remote device (60).

[0095] In a seventieth aspect according to any one of the previous aspects, the controller (51) of the remote device (60) is configured to emit a configuration signal in the form of an optical pattern (80) on the display (62) of the remote device (60) or in the form of a frequency-related signal, such as based on NFC, RFid or radio frequency technology. [Brief description of the drawings]

[0096] Certain embodiments and aspects of the present invention are described below with reference to the accompanying drawings, which are provided by way of example only. [Figure 1] FIG. 1 is a schematic diagram of an extracorporeal blood treatment device. [Diagram 2] , [Diagram 3] 2 and 3 are schematic diagrams of dialysis and blood circuits for chronic dialysis treatment. [Figure 4] FIG. 4 is a schematic diagram of a remote device having a user interface showing configuration parameter values ​​related to patient information. [Diagram 5] FIG. 5 is a schematic diagram of a remote device having a user interface showing configuration parameter values ​​associated with a treatment configuration. [Figure 6] FIG. 6 is a schematic diagram of a remote device having a user interface showing configuration parameter values ​​associated with a patient prescription. [Figure 7] FIG. 7 is a schematic diagram of a remote device having a display for visualizing an optical pattern encoding configuration parameters. [Figure 8] FIG. 8 is a schematic diagram of a remote device proximate to a medical device during an acquisition procedure. [Figure 9] FIG. 9 is a flow chart including steps of a configuration method according to an embodiment of the present invention. [Figure 10] FIG. 10 is a flow chart including steps of a configuration method according to a further embodiment of the invention. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0097] definition In this detailed description, corresponding parts shown in the various figures are given the same references. The figures may illustrate the invention by non-scale representations, and therefore the parts and components shown in the figures relevant for the purposes of the invention may relate only to schematic representations.

[0098] Upstream and downstream The terms upstream and downstream refer to the direction of forward movement or trajectory of fluid configured to flow within the fluid lines of the device's circuit during normal use of the device (eg, during treatment).

[0099] A setting method 1000 and an associated system 90 for setting a medical machine are described in detail below. The setting method 1000 and the associated system 90 may be implemented in an extracorporeal blood treatment device 1, more particularly the latter may be a dialysis device for carrying out a treatment such as an extracorporeal membrane oxygenator, an ultrafiltration treatment UF, a hemodialysis treatment HD, a hemofiltration treatment HF or a hemodiafiltration treatment HDF. The dialysis device may be intended for chronic or acute treatment. Alternatively, the method and the associated system may be implemented in a peritoneal dialysis device. Furthermore, the method and the associated system may be implemented in an infusion pump.

[0100] Setting method 1000 The configuration method 1000 is directed to providing configuration parameter values ​​70 to a medical device to perform a medical procedure. The term "medical device" may refer to a number of different medical devices that require a configuration procedure to initiate a proper medical procedure associated with an identified patient. The configuration procedure may be associated with a patient, for example, according to a patient prescription 73 provided by a clinician.

[0101] 9, the method 1000 includes a remote procedure 100 comprising a step 101 of providing a remote device 60 with a user interface 61, a step 102 of inputting a setting parameter value 70 into the remote device 60 by means of the user interface 61, and a step 103 of generating, by a signal generator, a setting signal encoding the setting parameter value 70, the setting signal being variable depending on the input setting parameter value 70. A change in the setting parameter value 70 corresponds to a change in the setting signal.

[0102] 4-8, the remote device 60 may be a smartphone, tablet or electronic tool for allowing a user to input the setting parameter values ​​70, and in this regard, the user interface 61 may include an input device 63, such as a keyboard, mouse or touch screen, for allowing a user to input or select the setting parameter values ​​70. In particular, the remote device 60 may be a handheld device having dimensions and weight suitable for easy transportation, i.e., allowing a user to hold the remote device 60 in his / her hand.

[0103] In particular, the remote device 60 and the medical device, such as an extracorporeal blood treatment device, are separate and distinct from one another. Specifically, the term "remote" indicates that the remote device 60 is separate from the medical device 1 and can be used remotely from the medical device 1 to input configuration parameter values ​​70. It is envisioned that the patient will be located at or in close proximity to the medical device.

[0104] For example, a user, i.e. a nurse, may hold the remote device 60 far from the medical apparatus 1, i.e. at a distance that prevents the nurse from directly operating the medical apparatus, at which stage the nurse, while located away from the patient, inputs the setting parameter values ​​70 into the remote device 60 via the input device 63 of the user interface 61 of the remote device 60. The nurse then commands the remote device 60 to generate, by means of a signal generator, a setting signal encoding the setting parameter value 70.

[0105] The configuration signal may comprise an optical pattern 80, such as a barcode, a QR code, a steganographic image, as shown in Fig. 7. The optical pattern 80 may be black and white, grayscale, or may comprise color, i.e. RGB colors. Thus, the step 103 of generating the configuration signal comprises a step of generating the optical pattern on a display, i.e. the display 62 of the remote device. Alternatively or in addition, the configuration signal may comprise a frequency-related signal, such as based on Near Field Communication NFC or RFid communication technology. Thus, the step 103 of generating the configuration signal comprises a step of generating the frequency-related signal by an emitter of the remote device.

[0106] The configuration parameter value 70 is encoded into a barcode, a QR code, a steganographic image, an NFC or an RFid signal. Changes in the configuration parameter value 70 correspond to changes in the optical pattern 80 or frequency related signal.

[0107] The setting parameter values ​​70 define the settings of the medical device, are associated with an identified patient, and are part of a patient prescription 73 for the identified patient. In particular, the setting parameter values ​​70 include a number of instructions for the extracorporeal blood treatment device to subsequently perform a medical procedure on the patient, such as an extracorporeal blood treatment. Since the setting parameter values ​​70 define the settings of the medical device, these parameters are necessary for the medical procedure to be performed. In particular, the manner in which the treatment is performed is associated with the patient prescription 73. In particular, the setting parameter values ​​70 are strictly associated with an identified patient.

[0108] The remote procedure 100 may be performed remotely at a safety distance with respect to the patient and / or with respect to the medical device 1, in particular the remote procedure 100 may be performed at a safety distance between 2 meters and 100 meters, in particular between 3 meters and 50 meters, more particularly between 4 meters and 20 meters. The remote procedure may be performed separately from the patient by a barrier, in particular the user in charge of performing the remote procedure is separated from the patient and / or the medical device 1 by this barrier, which may be a wall, a window or a transparent wall. More particularly, this barrier and this safety distance are configured to isolate the user in charge of inputting the setting parameter values ​​70 into the remote device 60 from the patient, in order to avoid the transmission of bacteria and / or viruses between the patient and the user.

[0109] The set parameter values ​​70 are part of the patient prescription 73 and include at least one of the patient fluid removal rate PFR of the identified patient and two parameters of the identified patient: total body weight loss WL, total treatment time TT and ultrafiltration flow rate UFR. In particular, the patient fluid removal rate PFR corresponds to the fluid rate removed from the patient during acute dialysis treatment (e.g. in an intensive care unit). In acute treatment, the total treatment time is not provided, since the patient may remain in treatment for days, weeks or even longer periods. The prescription therefore includes the patient fluid removal rate, i.e. the fluid that is intended to be removed from the patient per unit time. The patient fluid removal rate PFR may be dimensionally defined in ml / min.

[0110] By contrast, in chronic treatment, the patient undergoes several sessions per week of pre-defined duration. During each session, a certain amount of fluid must be removed, primarily to accommodate the fluid overload acquired during successive sessions. The total weight loss WL corresponds to the weight of fluid removed from the patient during chronic dialysis treatment. The total weight loss may be dimensionally defined in liters or kg. In particular, the total weight loss WL, the total treatment time TT and the ultrafiltration flow rate UFR are linked to each other by the following formula: WL=UFR·TT Where: WL=Total weight loss UFR=ultrafiltration flow rate TT = total treatment time It is.

[0111] Thus, the total weight loss depends on both the total treatment time and the ultrafiltration flow rate. The user may set the total weight loss and the total treatment time, or may input the ultrafiltration flow rate and the total treatment time that define the total weight loss, which are combined according to the formula above. Two of the three parameters are set, thereby defining the missing parameter.

[0112] The patient prescription 73 may also comprise several flow rate values ​​to be set in the extracorporeal blood treatment device, such as blood flow rate, pre-blood pump PBP flow rate, syringe flow rate, fresh dialysis flow rate, and substitution fluid flow rate. The flow rates to be set depend on the treatment type selected. Typically (but not exclusively), the PBP flow rate is set in the case of a local anticoagulation procedure that requires a local anticoagulant (e.g., citrate) to be injected into the blood upstream of the blood pump. In such cases, the syringe flow rate may generally refer to the injection of a calcium solution (either into the venous return line or directly into the patient) to balance calcium losses in the filtration unit.

[0113] Alternatively, the syringe may inject heparin or other systemic anticoagulant into the drainage line.

[0114] The substitution fluid may include dialysate, which, in the case of HF or HDF treatment, is infused into the blood circuit upstream and / or downstream of the filtration unit.

[0115] The method may include displaying the patient prescription 73 on a user interface 61, i.e., a display 62 of the remote device 60, as shown in FIG. 6, and allowing a user to input values ​​for the patient prescription 73, such as a patient fluid removal rate PFR (acute field), or alternatively, a total weight loss WL, a total treatment time TT and an ultrafiltration flow rate UFR.

[0116] The setting parameter values ​​70 may also include a treatment configuration 72 including a dialysis treatment type, ie, whether the medical procedure is an ultrafiltration treatment UF, a hemodialysis treatment HD, a hemofiltration treatment HF, or a hemodiafiltration treatment HDF.

[0117] The treatment configuration 72 may also include a selection of a disposable fluid line set type, which may represent a dialysis treatment type. The disposable fluid line set type includes a batch of fluid lines that define a blood circuit and optionally an infusion line; specifically, the fluid lines may include the blood withdrawal line 6, the blood return line 7, and optionally the infusion line 34.

[0118] In the case of machines for acute treatment dialysis, the disposable fluid line set may also include the fluid lines that define the dialysis circuit. Alternatively, in the case of machines for chronic treatment dialysis, the dialysis circuit consists of permanent fluid lines that need to be primed and sterilized for each treatment.

[0119] In particular, each disposable fluid line set may correspond substantially to a particular dialysis treatment type, and in particular, hemodiafiltration treatment HDF is associated with a corresponding disposable fluid line set. Alternatively, a generic disposable fluid line set may be available that allows for performing several different therapies (e.g., UF, HD, and HDF). More generally, a disposable fluid line set allows for performing multiple, but not all, dialysis treatment types.

[0120] Furthermore, the treatment configuration 72 may comprise a dialysis filter or filter set type indicating the dialyzer type, or a disposable set including the dialyzer type, i.e., the filtration unit 2. The dialyzer type may vary depending on patient information, such as the patient's age, or depending on the treatment type. For example, a dialyzer for ultrafiltration treatment UF may technically be different from a dialyzer for hemodiafiltration treatment HDF.

[0121] The treatment configuration 72 may further include anticoagulation settings for the extracorporeal blood treatment device, specifically anticoagulation may be selected from among heparin anticoagulation (systemic) and local anticoagulation, such as citrate anticoagulation.

[0122] Additionally, the treatment configuration 72 may indicate the presence (ie, the need) or absence of a blood warmer in the extracorporeal blood treatment device.

[0123] The method may include displaying the treatment configuration 72 on a user interface 61, i.e., display 62, of the remote device 60 to allow a user to input values ​​for the treatment configuration 72, as shown in FIG. 5, and the user may input values ​​associated with the treatment configuration 72 or indicate a treatment type, a filter type, an anticoagulation setting, and / or the presence or absence of a blood warmer.

[0124] The setting parameter values ​​70 may also include patient information 71, including patient identification information, such as a name or identification code, to enable a user, i.e., a nurse, to identify a patient before starting a medical procedure. In particular, the treatment configuration 72 and the patient prescription 73 are strictly patient-related, and therefore, the identification of a patient who needs to receive treatment is fundamental for starting a treatment. Furthermore, the patient information 71 may include the patient's age, the patient's weight, the patient's hematocrit value, the patient's sex, and the patient's associated diseases. The patient's hematocrit value may be measured before starting a treatment and / or before defining the patient prescription 73, so that the patient's hematocrit value may be set according to the hematocrit value. The method may include displaying the patient information 71 on the user interface 61, i.e., the display 62, of the remote device 60, to enable a user to input a value for the patient information 71, as shown in FIG. 4, and the user may input values ​​for the patient information 71, such as the patient's identification.

[0125] The method further includes an acquisition procedure 200, including a step 201 of transmitting a setting signal encoding a setting parameter value 70, a step 202 of providing a reader 40 to the medical device, a step 203 of reading the setting signal by bringing the reader 40 of the medical device relatively close to the remote device 60, and a step 204 of acquiring the setting parameter value 70 via the reading step, as in Fig. 9. The medical device is then configured based on the value of the setting parameter value 70. In particular, the acquisition procedure 200 is performed after the remote procedure 100 in time, i.e., when the setting parameter value 70 is entered by a user, i.e., by a nurse or clinician, into the remote device 60. Furthermore, the acquisition procedure 200 is performed at an acquisition distance from the patient and / or from the medical device 1, and the remote procedure 100 is performed at a remote distance from the patient and / or from the medical device, the remote distance being greater than the acquisition distance. In other words, the acquisition procedure is performed locally close to the patient and close to the medical device 1 performing the medical procedure on the patient.

[0126] During the acquisition procedure 200, the user responsible for performing the acquisition procedure is at an acquisition distance from the patient and / or the medical device that is less than 10 meters, in particular less than 5 meters, in particular less than 3 meters, more particularly less than 1 meter. In particular, the medical device may be an extracorporeal blood treatment device 1 and the medical procedure may be an extracorporeal blood treatment, such as a dialysis treatment.

[0127] Moreover, the time required to perform the acquisition procedure is also much shorter than the time required to perform the remote procedure, i.e. the time required for the doctor / nurse. More specifically, the method performs the remote procedure at a remote time interval and performs the acquisition procedure at an acquisition time interval, the acquisition time interval being much shorter than the remote time interval. For example, the acquisition time interval may last between 0.1 and 40 seconds, more specifically between 1 and 20 seconds, more specifically between 2 and 10 seconds. Meanwhile, the remote time interval may last between 1 and 30 minutes, more specifically between 1.5 and 20 minutes, more specifically between 2 and 5 minutes.

[0128] Thus, the acquisition time interval may be at least 30% shorter than the remote time interval, specifically 50% shorter, more specifically 80% shorter, and even more specifically 90% shorter.

[0129] In particular, the remote time interval may be defined as the average time required for a user, i.e., a doctor / nurse, to input all the setting parameters of a medical device capable of performing the relevant medical procedure or an extracorporeal blood treatment device capable of performing the relevant extracorporeal blood therapy. This period may take into account the time to enter all the setting parameter values ​​into a keyboard.

[0130] On the other hand, the acquisition time interval is defined in particular as the time period required for the control unit 50 of the device 1 to carry out at least the following steps of the acquisition procedure: - reading the configuration signal by bringing the medical device reader 40 relatively close to the remote device 60; and - obtaining a setting parameter value 70 via a reading step; - optionally configuring the device (1) based on configuration parameter values ​​(70); It is.

[0131] In particular, based on the fact that the acquisition procedure is performed by an electronic control unit, i.e., control unit 50, and based on the fact that the input steps of the remote procedure are performed manually by an operator, the acquisition time interval is essentially shorter than the remote time interval.

[0132] The fact that the acquisition time interval is much shorter than the remote time interval allows the operator, i.e., the nurse, to reduce the time spent in close proximity to the patient, thereby reducing the patient's risk of exposure to communicable diseases.

[0133] The step of emitting the setting signal may include a step 201 of displaying on a display an optical pattern 80 encoding the setting parameter value 70. The display may be the display 62 of the remote device 60, so that the remote device 60 comprises in a single body an input device 63 allowing the user to insert the setting parameter value 70 and a display 62 for visualizing the optical pattern 80 encoding the setting parameter value 70. The display 62 may be an LCD, an LED screen, or any other suitable electronic screen. Alternatively, the display on which the optical pattern is displayed may be separated and differentiated by the user interface 61 of the remote device 60, so that the remote device 60 allows the user to insert the setting parameter value 70 and then transmits a command to the remote display to display the corresponding optical pattern 80 and show it to the medical device reader 40.

[0134] In particular, the step of displaying the optical pattern on the display may alternatively be part of the remote procedure 100. In other words, the step of displaying the optical pattern on the display may be performed at a remote distance rather than at the acquisition distance.

[0135] When an optical pattern is used, the acquisition step is actively performed only by the medical device that needs to read the optical pattern and decode the information.

[0136] The step of emitting the configuration signal may alternatively include emitting 201 a frequency-related signal, such as an NFC, RFid or radio signal, encoding the configuration parameter value 70. The remote device 60 may comprise an emitter configured to emit the frequency-related signal.

[0137] The reader 40 of the medical device 1 may be configured to read the optical pattern 80 encoding the configuration parameter value 70, in particular the reader 40 may be configured to read or scan a barcode, a QR code or a steganographic image. Alternatively, the reader 40 may be configured to read a frequency-related signal, such as an NFC, RFid or radio frequency signal, emitted by the remote device 60. In particular, the reading step 203 comprises bringing the medical device reader 40 close to the remote device 60 at a distance less than 50 cm, in particular less than 20 cm, more particularly less than 10 cm. Optionally, the reading step comprises bringing the medical device reader 40 into contact with the remote device 60.

[0138] Obtaining 204 the set parameter value 70 via reading may include decoding the optical pattern 80 or the frequency related signal to obtain the set parameter value 70. The decoding may be performed by the control unit 50 of the medical device.

[0139] The method then includes storing the set parameter values ​​70 in a memory of a medical device used to set up a medical procedure such as an extracorporeal blood therapy, i.e., a dialysis therapy.

[0140] The method may also include a step of providing the medical device with at least one disposable component necessary for the medical procedure to be performed. For example, the disposable component may be a filter unit 2, i.e. a dialyzer, to be attached to the extracorporeal blood treatment device, as in FIG. 1. Furthermore, the disposable component may be a bag 33 containing a liquid to be injected into the dialysis circuit or a medical liquid and / or powder solution to be prepared in the blood circuit. For example, the disposable component may be a bicarbonate bag for injecting a bicarbonate liquid solution into the patient's bloodstream. In particular, the component is a disposable component that needs to be replaced at each treatment session.

[0141] Each disposable component includes a respective identification code, such as a label attached thereto, to identify the component type. For example, the identification code may identify whether the dialysis machine is for high-flux or low-flux dialysis treatment, or whether the dialysis machine is intended to treat children or adults, or may identify the composition of the infusion bag.

[0142] The method may further include a consistency procedure 300, including a step 303 of verifying the consistency between the identified disposable components and the setting parameter values ​​70 obtained by reading the optical image from the display, as in FIG. 10. As mentioned above, the setting parameter values ​​70 may include an indication of the dialysis type, specifically whether ultrafiltration (UF), hemodialysis (HD), hemofiltration (HF), hemodiafiltration (HDF) is performed, and the consistency procedure is directed to verifying whether all components are compatible with the dialysis type. For example, the setting may include a pre-dilution infusion flow rate and a dialysis flow rate, and the dialysis type should be compatible with the imposed flow rate, i.e., should include a dialysis line and a pre-infusion line (which is a disposable HDF dialysis type before infusion). Alternatively, if the setting parameter values ​​70 indicate that the patient is a child, the consistency procedure verifies whether all components are suitable for children based on their respective identification codes. Furthermore, if the setting parameter values ​​70 indicate the presence of a blood warmer, the consistency procedure verifies the presence of a blood warmer associated with the dialysis machine.

[0143] Obviously, the matching procedure implies a step 301 of reading the identification code of each component, which, in case the identification codes of the components are in the form of optical patterns, may be performed by a reader 40 of the medical device, so that the reader 40 may be used to read both the optical patterns of the disposable components and the optical patterns 80 encoding the setting parameter values ​​70. Alternatively, in case the identification codes of the disposable components are in the form of frequency-related signals, the step of reading the identification codes of the components may be performed by a frequency scanner different from the reader 40 of the device.

[0144] More specifically, the matching procedure 300 may include verifying 303 whether the identification code of the component matches the treatment identification information of the device according to a predefined matching list. The treatment identifier indicates the type of dialysis treatment to be performed, which may be one of the setting parameter values. In particular, the matching list may include the treatment identifiers respectively indicating ultrafiltration (UF), hemodialysis (HD), hemofiltration (HF), hemodiafiltration (HDF) and optionally peritoneal dialysis (PD), and the list further includes a series of identification codes of the matching disposable components that match the procedure identifier. Thus, the matching between the disposable components and the setting parameter values ​​70 is performed based on this predefined list linking each setting parameter value to one or more identification codes of the matching disposable components.

[0145] The method then includes preventing the medical device from being configured based on the configuration parameter values ​​70 if at least one configuration parameter does not match an identified disposable component for the medical device, specifically the extracorporeal blood treatment device. Conversely, the method may allow the medical device to be configured based on the configuration parameter values ​​70 if all configuration parameter values ​​70 match an identified disposable component for the medical device, specifically the extracorporeal blood treatment device.

[0146] Further, the consistency procedure 300 may include a step 302 of defining a respective threshold range for one or more set parameter values ​​70 based on the identification code of the disposable component. For example, the consistency procedure may include a step 302 of defining a respective threshold range for at least one of the following two parameters for the identified patient: the patient fluid removal rate PFR for the identified patient, the total weight loss WL, the total treatment time TT, and the ultrafiltration flow rate UFR for the identified patient based on the identification code of the component. Specifically, the consistency procedure may define a threshold range for the total weight loss WL based on the identification code, and the threshold range for the total weight loss WL may be set between 0.1 Kg and 6 Kg. The threshold range for the blood flow rate may be set between 50 ml / min and 600 ml / min. Of course, appropriate thresholds will depend on the particular medical device, for example, whether the medical device is for an acute patient (e.g., blood flow range thresholds are reasonably reduced, such as between 50 ml / min and 300 ml / min) or for a chronic patient (e.g., blood flow rates between 150 ml / min and 600 ml / min). Once the thresholds are set, the consistency procedure includes determining whether one or more setting parameter values ​​70 exceed the respective threshold ranges, i.e., if one or more setting parameter values ​​70 are outside the respective threshold ranges, then if one or more setting parameter values ​​70 exceed the respective threshold ranges, then the method includes preventing the extracorporeal blood treatment device from being set based on the setting parameter values ​​70.

[0147] In particular, each threshold range may refer to a respective value associated with at least one of the patient information 71, and the method may define 302 a threshold range for the patient's weight and / or age based on an identification code of a disposable part installed in the device. For example, the identification code of a disposable part installed in the device may define a patient age threshold range between 18 and 80 years old or between 1 and 3 years old. If the patient's actual age exceeds the respective age threshold range, the method prevents the extracorporeal blood treatment device from being configured based on the configuration parameter value 70.

[0148] In other words, the set parameter values ​​70 must remain within respective threshold ranges depending on the disposable components installed in the medical device.

[0149] As mentioned above, the set parameter values ​​70 may include a patient identification, i.e., patient information 71 including the patient's name, identifying the patient to which the set parameter values ​​70 relate. The method may then include a cross-check procedure 400 that is performed to ensure that the medical procedure is performed on the right patient, in other words the cross-check procedure 400 includes a step of associating the extracorporeal blood treatment device with the patient intended to receive the extracorporeal blood treatment. The association between the extracorporeal blood treatment device and the patient is performed by providing 401 the extracorporeal blood treatment device with an identification of this patient from a source different from the optical pattern 80, for example this identification may be provided by an identification card or an identification wearable device, such as a wearable bracelet on the patient's wrist, which may be scanned by an identification scanner of the medical device. Thus, the medical device may be equipped with an identification scanner configured to scan the patient's identification card. The patient's identification card may be a label including a barcode or a QR code, or alternatively the identification card may include an NFC or RFid circuit or a radio frequency emitter. Similarly, the identity wearable device may include a label including a barcode or QR code, alternatively the identity wearable device may include an NFC or RFid circuit or a radio frequency emitter. Alternatively the actual name of the patient may be entered manually by a user, i.e. by a nurse, via a keyboard into the medical device. The identity scanner of the device 1 may be the same frequency scanner of the device 1 described above and may be configured to scan the optical pattern of the disposable component, in which case the frequency scanner and the identity scanner may define a single scanner configured to identify both the patient and the component.

[0150] Furthermore, the identification scanner of the device 1 may be the same reader 40 of the device 1 configured to scan the optical pattern 80 encoding the setting parameter values ​​70 as described above, in which case the identification scanner and reader 40 may define a single scanner configured to both identify the patient and read the optical pattern 80 encoding the setting parameter values ​​70.

[0151] In a further embodiment, the frequency scanner, the identification scanner and the reader 40 may be combined to define a single device configured to read the optical pattern 80 encoding the setting parameter values ​​70, to read the patient identification code, and to read the identification code of the disposable component.

[0152] The cross-check procedure 400 further includes a step 402 of checking for a match between the patient identification information of the setting parameter values ​​70 read via the optical pattern 80 and identification information related to the patient provided via an information source different from the optical pattern 80. If no match is found between the patient identification information contained in the setting parameter values ​​70 and the identification information related to this patient provided by the information source, the cross-check procedure 400 includes preventing the extracorporeal blood treatment device from being configured based on these setting parameter values ​​70. Additionally, the cross-check procedure 400 may also issue an alarm, i.e., an acoustic or visual alarm.

[0153] In particular, the cross-check procedure 400 is performed at a cross-check distance that is substantially equal to the acquisition distance from the patient and / or from the medical device 1. In particular, the cross-check distance is much smaller than the remote distance.

[0154] The acquisition procedure may also include a safety procedure including a step 500 of verifying the validity of the setting parameter values ​​70 acquired by the optical pattern 80 encoding the setting parameter values ​​70, specifically the safety procedure includes a step 501 of defining a predetermined valid range and a step 502 of verifying whether all the setting parameter values ​​70 are within this predetermined valid range. For example, the safety procedure may include verifying whether the patient's age included in the setting parameter values ​​70 is within a reasonable range, i.e., between 3 and 99 years old. Similarly, the safety procedure may include verifying whether the total weight loss WL included in the setting parameter values ​​70 is within a reasonable valid range, i.e., between 0.1 kg and 8 kg. If one or more of the setting parameter values ​​70 exceed the valid range, the method prevents the extracorporeal blood treatment device from being configured based on these setting parameter values ​​70. Furthermore, if one or more of the setting parameter values ​​70 exceed the valid range, the method may also include instructing the extracorporeal blood treatment device to emit an alarm signal, such as an acoustic alarm signal or an alarm displayed on a display of the extracorporeal blood treatment device.

[0155] The acquisition procedure may include a verification procedure temporally following a step of acquiring the setting parameter values ​​70 by reading the optical pattern 80 via the reader 40. The verification procedure may be performed by the device 1 and includes the steps of displaying one or more of the setting parameter values ​​70 on a display, i.e. the display of the device 1, and requesting to receive from the user an acknowledgement signal of the setting parameter values ​​70 received by the device 1. The verification procedure may further include the step of checking whether an acknowledgement signal has been received by the device 1.

[0156] The acknowledgement signal may comprise the pressing of a button, ie a physical or virtual button shown on the display of the device 1, which in this regard may be a touch screen.

[0157] If the approval signal is properly received by the device 1, the validation procedure enables performing the step of configuring the extracorporeal blood treatment device 1 based on the value of the setting parameter value 70 received by the device 1. Conversely, if the approval signal is not properly received by the device 1, the validation procedure prevents performing the step of configuring the extracorporeal blood treatment device 1 based on the value of the setting parameter value 70 received by the device 1.

[0158] The request step of the validation procedure may also include a step of requesting one unique acknowledgement signal indicating acknowledgement of all configuration parameter values ​​70 received by the device 1 .

[0159] Alternatively, the request step of the validation procedure may include dividing the setting parameter values ​​70 into two or more groups including each setting parameter value 70 received by the device 1 and requesting an acknowledgement signal for each group of setting parameter values ​​70. The setting parameter values ​​70 may be divided into these groups based on the category of each setting parameter value, i.e., at least a flow rate group may be provided that includes only setting parameter values ​​related to flow rates for setting the extracorporeal blood treatment device 1. For example, an identification information group may be provided that includes only setting parameter values ​​related to patient identification information. Furthermore, a therapy group may be provided that includes only setting parameter values ​​related to the treatment configuration 72. In particular, the validation procedure may include providing at least one of the flow rate group, the identification information group and the therapy group, or all of the flow rate, the identification information and the therapy group.

[0160] Alternatively, the request step of the validation procedure may involve requesting, for each of the configuration parameter values ​​70 , a respective acknowledgement signal indicating acknowledgement of each configuration parameter value 70 received by the device 1 .

[0161] The method may also include a step 600 of pairing the remote device 60 with the extracorporeal blood treatment apparatus based on an authentication code that allows an authorized user to perform the pairing step, and the authentication code may include at least one of a password, a serial number, a fingerprint, a facial recognition algorithm. The pairing may be based on NFC or Bluetooth protocols, for example the remote device 60, i.e. a tablet or a smartphone, is paired to the medical apparatus via a Bluetooth connection.

[0162] If the pairing step 600 is successful, the method performs the acquisition procedure 200, and conversely, if the pairing step is not successful, the method prevents the acquisition procedure 200 from being performed or the method prevents the configuration parameter values ​​70 from configuring the extracorporeal blood treatment device.

[0163] In particular, the method 1000 may include pairing 600 the remote device 60 with the extracorporeal blood treatment device 1 each time the configuration parameter values ​​70 are acquired and read by the reader 40. Optionally, the method 1000 may include pairing 600 the remote device 60 prior to reading the optical pattern 80 by the reader 40 of the medical device, and once the remote device 60 is paired with the medical device, the method 1000 enables the reading step 203 and acquisition procedure to be performed.

[0164] In one embodiment, the optical pattern 80 encoding the configuration parameter values ​​70 may further include an authentication code that enables pairing of the remote device 60 with a medical device, specifically an extracorporeal blood treatment device. For example, a barcode or QR code may encode both the configuration parameter values ​​70 and an authentication code to perform the pairing step.

[0165] According to an optional embodiment, the step 201 of displaying the optical pattern 80 on the display of the remote device 60 is dependent on successful pairing between the remote device 60 and the medical device, and if the pairing is not successful, the method prevents the optical pattern 80 from being displayed on the display 62 of the remote device 60. Notably, in this optional embodiment, the remote device 60 comprises both a display 62 and an input device 63 (i.e. as a smartphone or tablet).

[0166] In a further embodiment that does not require any pairing between the remote device and the medical device, the operator must enable the reading of the optical code on the medical device before the acquisition procedure. For example, the operator must enter his / her ID directly via the medical device user interface, and the latter can be acquired and / or used by the medical device only if the medical device verifies the appropriate authority to configure the medical device via the optical code. This avoids the need for any pairing or bidirectional communication between the remote device and the medical device.

[0167] In an embodiment in which the user interface 61 of the remote device 60 comprises both a display 62 and an input device 63 for inputting the setting parameter values ​​70, the method further comprises a local procedure 700, intervening in time between the remote procedure and the acquisition procedure, comprising a step 701 of inputting one or more further setting parameter values ​​70 to the remote device 60 via the user interface 61 of the remote device 60. The further setting parameter values ​​70 include one or more of the setting parameter values ​​70, for example at least one of a patient prescription 73, a treatment configuration 72 and patient information 71. Alternatively or additionally, the local procedure comprises a step 701a of modifying or updating, via the user interface 61 of the remote device 60, one or more of the setting parameter values ​​70 input during the remote procedure. The user may update setting parameter values ​​related to the prescription or patient information 71, such as weight or hematocrit value. In particular, the local procedure 700 is performed by a user at a local distance from the patient and / or from the medical device, and the remote procedure 100 is performed by a user at a remote distance from the patient and / or from the medical device, the local distance being shorter than the remote distance. In particular, the local distance is shorter than 10 meters, in particular shorter than 5 meters, more particularly shorter than 3 meters, more particularly shorter than 1 meter. In effect, the local distance corresponds to the acquisition distance of the acquisition procedure, in other words, the local procedure 700 and the acquisition procedure 200 are performed at substantially the same location, in particular at the same distance relative to the patient and / or the medical device.

[0168] FIG. 9 shows a flow chart including the main steps of a remote procedure 100 and an acquisition procedure 200 according to an embodiment of the invention.

[0169] Fig. 10 shows a flow chart according to a further embodiment of the invention, including the main steps of a remote procedure 100, an acquisition procedure 200, an integrity procedure 300, a cross-check procedure 400, a safety procedure 500, a pairing step 600 and a local procedure 700. In particular, the flow chart of Fig. 10 does not limit the method to include all of these steps 100, 200, 300, 400, 500, 600, 700, and the method may in fact include one or more of any combination of the integrity procedure 300, the cross-check procedure 400, the safety procedure 500, the pairing step 600 and the local procedure 700 in addition to the remote procedure 100 and the acquisition procedure 200, as indicated by the horizontal flow arrows of Fig. 10.

[0170] system The present invention is also directed to a system 90 comprising both the medical apparatus 1 and the remote device 60 .

[0171] The remote device 60 may be a portable device such as a smartphone, a tablet, etc., as shown in Figs. 5 to 8. The remote device 60 at least comprises a user interface 61 configured to allow a user to input a setting parameter value 70, and a controller 51 that allows the user to input the setting parameter value 70 via the user interface 61. Specifically, the user interface 61 comprises an input device 63 such as a keyboard. Furthermore, the controller 51 is also configured to generate a setting signal encoding the setting parameter value 70, which may be an optical pattern 80 or a frequency-related signal such as an NFC, RFid or radio frequency signal encoding the setting parameter value 70.

[0172] The user interface 61 of the remote device 60 may also comprise a display 62 connected to the controller 51 and configured to visualize, i.e. display on a screen, the optical pattern 80. In this regard, the controller 51 is configured to encode setting parameter values ​​in the optical pattern 80 and then display this optical pattern 80 on the display 62 of the remote device 60 or a remote display (not shown in the accompanying figures). Similarly, the controller 51 may be configured to encode setting parameter values ​​in the optical pattern 80 and then emit a frequency-related signal through the emitter.

[0173] Furthermore, the remote device 60 comprises an electric battery configured to supply the controller 51 and the user interface 61 , ie the display 62 and the input device 63 .

[0174] Alternatively, the remote device 60 may comprise an emitter configured to emit a frequency-related signal, such as an NFC, RFid or radio frequency signal, that encodes the configuration parameter value 70. In this case, the remote device 60 may not comprise a display.

[0175] According to one embodiment, the remote device 60 defines a unitary body comprising a case carrying at least a display 62, a battery, an input device 63 and a controller 51, as in Figures 5-8. The display 62 and the input device 63 may be combined to define a touch screen.

[0176] Instead, the remote device 60 defines a unitary body including a case carrying at least the emitter, the battery, the input device 63 and the controller 51 .

[0177] The controller 51 of the remote device 60 is configured to enable the execution of the remote procedure 100, such as steps 101, 102, 103 described above, in particular the controller 51 is configured to enable the input of values ​​for setting parameter values ​​70 via the user interface 61. The setting parameter values ​​70, already mentioned in the description of the method, define the settings of the extracorporeal blood treatment machine and are associated with an identified patient. The setting parameter values ​​70 are part of a patient prescription 73 for the identified patient and include at least one of the patient fluid removal rate PFR of the identified patient and two parameters of the identified patient: total weight loss, total treatment time and ultrafiltration flow rate.

[0178] The above description related to the method generally often refers to a medical device 1 for brevity: in any case, the medical device may be an extracorporeal blood treatment device, such as a dialysis device as shown in FIG. 1. The dialysis device may be configured to perform ultrafiltration treatment UF, hemodialysis treatment HD, hemofiltration treatment HF, or hemodiafiltration treatment HDF. The dialysis device 1 may be intended for chronic or acute treatment. Furthermore, the extracorporeal blood treatment device may be an extracorporeal membrane oxygenator configured to remove CO2 and / or oxygenate the patient's blood. In one embodiment, the extracorporeal blood treatment device may be configured to perform dialysis treatment and remove CO2 with a membrane oxygenator (in other words, the device includes one filtration unit for dialysis treatment and a membrane oxygenator for removing CO2). Alternatively, the medical device 1 may be a peritoneal dialysis device or an infusion pump.

[0179] The medical device of the present invention comprises a control unit 50 configured to execute the obtaining procedure 200 as outlined in Fig. 1 and as described above in the method section. More specifically, the medical device comprises a reader 40, the control unit 50 configured to command the reader 40 to obtain the setting parameter value 70 by reading the optical pattern 80, and then to configure the medical device based on the value of the setting parameter value 70. In other words, the control unit 50 is configured to execute the reading step 203 as described above.

[0180] The medical device 1 may also comprise a memory operatively connected to the control unit 50 configured to store the setting parameter values ​​70 .

[0181] The control unit 50 is also configured to execute a consistency procedure 300, specifically the control unit 50 of the medical device 1 is configured to read 301 the identification code of each component and to verify 303 the consistency between the identified disposable component and the set parameter values ​​70 obtained by reading the optical image from the display 62 of the remote device 60. Furthermore, the control unit 50 may be configured within the consistency procedure to execute a step 302 of defining, based on the identification code of the component, respective threshold ranges for at least one of the patient fluid removal rate PFR for the identified patient and two parameters for the identified patient among the total weight loss WL, the total treatment time TT and the ultrafiltration flow rate UFR. More generally, the control unit 50 of the medical device 1 may be configured to define 302 respective threshold ranges for one or more set parameter values ​​70 based on the identification code of the disposable component.

[0182] The control unit 50 may also be configured to perform a cross-check procedure 400 that is performed to ensure that a medical procedure is performed on the appropriate patient, in other words, the control unit 50 may be configured to enable association of the extracorporeal blood treatment device with a patient intended to receive the extracorporeal blood treatment.

[0183] In particular, the control unit 50 may be configured to receive 401 this patient identification information from an information source different from the optical pattern 80, and the control unit 50 is then configured to check 402 for a match between the patient identification information of the setting parameter values ​​70 read via the optical pattern 80 and identification information related to the patient provided via an information source different from the optical pattern 80. If no match is found between the patient identification information contained in the setting parameter values ​​70 and the identification information related to this patient provided by the information source, the control unit 50 is configured to prevent the extracorporeal blood treatment device from being configured based on these setting parameter values ​​70.

[0184] The control unit 50 may also be configured to execute a safety procedure 500 in order to check the validity of the setting parameter values ​​70, i.e. as captured by the optical pattern 80 encoding the setting parameter values ​​70. The control unit 50 is configured to define 501 a predefined validity range, as will be explained in detail in the method section, and then to verify 502 whether all setting parameter values ​​70 are within this predefined validity range.

[0185] The control unit 50 of the medical apparatus 1 and the controller 51 of the remote device 60 may also be configured to perform a step 600 of pairing the remote device 60 to the extracorporeal blood treatment apparatus 1 based on the authentication code. In particular, this pairing step may be performed by both the controller 51 and the control unit 50, and the pairing step may be performed by using NFC or Bluetooth protocols.

[0186] The controller 51 of the remote device 60 may also be configured to execute a local procedure 700 intervening in time between the remote procedure and the acquisition procedure, and the controller 51 may be configured to enable input 701 of one or more further setting parameter values ​​70 into the remote device 60 via the user interface 61 of the remote device 60. In other words, the controller 51 is configured to receive further setting parameter values ​​after the remote procedure from the user interface. The further setting parameter values ​​70 include one or more of the setting parameter values ​​70, for example at least one of a patient prescription 73, a treatment configuration 72 and patient information 71.

[0187] Alternatively or additionally, the controller 51 of the remote device 60 may be configured to allow a user to modify 701a or update 702 one or more of the configuration parameter values ​​70 entered during the remote procedure via the user interface 61 of the remote device 60. In particular, the controller 51 is configured to perform the local procedure 700 at a local distance from the patient substantially equal to an acquisition distance maintained during the acquisition procedure. In particular, the local distance is much shorter than the remote distance.

[0188] According to the embodiment shown in Figures 2 and 3, the extracorporeal blood treatment device comprises at least a filtration unit 2 having a primary chamber 3 and a secondary chamber 4 separated by a semipermeable membrane 5. The extracorporeal blood treatment device 1 further comprises a blood circuit comprising a blood removal line 6 extending between a first end connected to an inlet of the primary chamber and a second end for connection to a patient P. The extracorporeal blood treatment device further comprises a blood return line 7 extending between a first end connected to an outlet of the primary chamber 3 and a second end for connection to a patient P. Additionally, the extracorporeal blood treatment device comprises a blood pump 10 for circulating blood in the blood circuit and a drain line 12 connected to the outlet of the secondary chamber 4. The control unit 50 is also configured to control at least the blood pump 10, for example to operate or change the speed of the blood pump 10.

[0189] A chronic (long-term) hemodialysis (HD) machine compatible with the setting method and system of the present invention will be described in detail below. In particular, the following chronic dialysis circuit description is disclosed as an exemplary embodiment without limiting the present invention to chronic hemodialysis. In fact, the setting method can also be implemented in the case of acute extracorporeal blood therapy.

[0190] Extracorporeal blood treatment device 1 Chronic (long-term) hemodialysis (HD) treatment systems used in treatment for patients with chronic renal failure. HD treatments are typically performed several times per week (e.g., three times per week), with each treatment having an average duration of several hours (e.g., 3.5-4.5 hours).

[0191] A device 1 for extracorporeal blood treatment for chronic (long-term) treatment is shown in Figures 1 and 2. The device 1 comprises a filtration unit 2 having a primary chamber 3 and a secondary chamber 4 separated by a semipermeable membrane 5. Depending on the treatment, the semipermeable membrane 5 of the filtration unit 2 may be selected to have different properties and performances.

[0192] A blood circuit is coupled to the primary chamber 3 of the filtration unit 2. The blood circuit comprises a blood withdrawal line 6 connected to the inlet 3a of the primary chamber 3 and a blood return line 7 connected to the outlet 3b of the primary chamber 3. The blood withdrawal line 6 and the blood return line 7 are configured to connect to the cardiovascular system of a patient "P". During treatment, the patient has two accesses (artery / vein) through which blood flows in / out of the body, with an average blood flow typically between 250 ml / min and 500 ml / min.

[0193] In use, the blood withdrawal line 6 and the blood return line 7 are connected to a needle or catheter or other access device, which is then placed in fluid communication with the vascular system of a patient "P" so that blood may be withdrawn through the blood withdrawal line 6, flowed through the primary chamber 3, and then returned to the patient's vascular system via the blood return line 7. An air separator, such as a degassing chamber 8, may be present on the blood return line 7. Additionally, a monitor valve 9 may be present on the blood return line 7 downstream of the degassing chamber 8.

[0194] The blood flow through the blood circuit is controlled by a blood pump 10, e.g., a peristaltic blood pump, acting on either the blood removal line 6 or the blood return line 7. The embodiment of Fig. 2 shows the blood pump 10 coupled to the pump section of the blood removal line 6. Alternatively, blood pumps may be provided in both the blood removal line 6 and the blood return line 7. A control unit 50 is connected to and controls the blood pump 10 to regulate the blood flow rate.

[0195] The dialysis circuit is connected to the secondary chamber 4 of the filtration unit 2 and includes a dialysis supply line 11 connected to the inlet 4a of the secondary chamber 4, and a dialysis discharge line 12 connected to the outlet 4b of the secondary chamber 4 and to a drain (not shown). The dialysis discharge line discharges used dialysis fluid to the drain.

[0196] The dialysis supply line 11 is connected to a preparation device 13 for preparing fresh dialysis fluid. The preparation device 13 comprises a regulation device 14 for regulating the composition of the fresh dialysis fluid.

[0197] In the example of Figure 2, the preparation device 13 comprises three containers 15, 16, 17 of concentrates located in inlet lines 18, 19, 20 respectively, arranged to supply electrolytes, buffers or other substances towards a preparation line 21 of fresh dialysis fluid. The concentrate containers 15, 16, 17 may contain concentrates in liquid or solid state, for example powders.

[0198] The regulation device 14 comprises infusion pumps 22, 23, 24 disposed on the infusion lines 18, 19, 20 to move liquid along the respective infusion lines 18, 19, 20 towards a preparation line 21 which collects liquid, e.g., water, from a source 25. The preparation line 21 is located upstream of the dialysis supply line 11 and is connected at one end to a source 25, e.g., a deionized / purified water source or a reverse osmosis water plant, and at the other end to the dialysis supply line 11. The source 25 may include a water source, as shown, or a source of ultrapure liquid.

[0199] Concentration or conductivity sensors 26, 27, 28 may be disposed on the preparation line 21 to provide a signal related to the conductivity or concentration of a given substance (e.g. sodium) in the liquid passing across the preparation line 21 to a control unit 50 which may control the infusion pumps 22, 23, 24 to regulate the conductivity Cd or concentration, e.g. sodium [Na], of the liquid passing across the dialysis supply line 11. A liquid check mechanism 29 may be used to selectively allow or prevent passage of liquid across the dialysis line 21 into the filtration unit 2 if the liquid does not meet the required parameters.

[0200] An infusion line 11' leaves the dialysis supply line 11, specifically downstream of the preparation device 13, and is connected to the blood return line 7 for infusing a portion of fresh dialysate into the blood circuit. An auxiliary infusion pump 45 may be coupled to the infusion line 11' for delivering a portion of fresh dialysate into the blood circuit. Alternatively or additionally, the infusion line 11' may be connected to the settlement line 6, specifically downstream of the blood pump 10, for pre-infusion of substitution fluid.

[0201] The ultrafiltration device is configured to achieve fluid removal from the patient through the semipermeable membrane 5 of the filtration unit 2. The ultrafiltration device comprises a dialysis pump 30 arranged on the dialysis discharge line 12. In an alternative embodiment, a first dialysis pump is coupled to the dialysis supply line 11 and a second dialysis pump is coupled to the dialysis discharge line 12. A first flow meter 31 is active on the dialysis supply line 11 and arranged between the fluid check mechanism 29 and the inlet 4a of the secondary chamber 4. A second flow meter 32 is active on the dialysis discharge line 12 and arranged between the inlet 4a of the secondary chamber 4 and the dialysis pump 30.

[0202] The infusion line 11' is connected to the dialysis supply line 11 between the first flow meter 31 and the inlet 4a of the secondary chamber 4. The first flow meter 31 and the second flow meter 32 are connected to a control unit 50 and configured to determine the ultrafiltration rate UFR.

[0203] The ultrafiltration rate UFR is the difference between the used dialysate leaving the outlet 4b of the secondary chamber 4, the prepared fresh dialysate sent to the inlet 4a of the secondary chamber 4, and optionally the liquid injected into the blood circuit via the inlet line 11' (Figure 3).

[0204] As shown in Figure 3, Q b1 is the blood flow rate entering the primary chamber 3 through the inlet 3a, and Q b2 is the blood flow rate leaving the primary chamber 3 through the outlet 3b, and Q in is the flow rate entering the secondary chamber 4 through the inlet 4a, and Q infis the flow rate across the injection line 11′, where Q dial =Q in +Q inf It is.

[0205] The first flow meter 31 and the second flow meter 32 provide the control unit 50 with instantaneous values ​​of the respective flow rates, thus enabling the control unit 50 to calculate the instantaneous ultrafiltration rate UFR. Alternatively, differential sensors may be actively provided on the dialysis supply line 11 and on the dialysis discharge line 12, thus providing a signal directly regarding the ultrafiltration rate UFR. Instead of flow meters, a balance chamber may be operatively coupled to the dialysis circuit. The balance chamber principle works in such a way that the amount of liquid entering the first chamber on the dialysis supply line 11 is equal to the amount of liquid leaving the dialysis discharge line 12.

[0206] To achieve ultrafiltration, an ultrafiltration line (not shown) is added to the drain line upstream of the balance chamber. An ultrafiltration pump removes a desired amount of ultrafiltered fluid before the spent dialysate reaches the second balance chamber, thereby achieving an ultrafiltration volume. Of course, the absolute volume fluctuations through the ultrafiltration line can also be measured.

[0207] The device 1 may further comprise one infusion bag 33 containing an infusion solution, such as a substitution fluid or a nutrient substance, and an infusion line 34 having a first end in fluid communication with the infusion bag 33 and a second end connected to the blood return line 7 for infusing the solution into the patient's vascular system via the blood return line 7. In an alternative embodiment, the infusion solution may be infused directly into the patient's vascular system. An infusion pump 35 is coupled to the infusion line 34 in order to deliver the infusion solution via the infusion line 34. A sensing element in the form of a weighing device 36 is configured to weigh the infusion bag 33 while the solution is being infused and to provide a first signal that allows the calculation of a first parameter W related to the weight of the infusion bag 33 and thus to the weight or volume of the solution contained in the infusion bag 33. In general, the weighing device 36 provides a change in the bag weight over time that is directly related to the actual flow rate of the infusion solution through the infusion line. In fact, the control unit knows the cross section of the infusion line and can therefore easily and very accurately calculate the actual flow rate of the infusion solution through the infusion line from the measurements of the weight / weight change over time of the corresponding bag. Optionally, the first parameter is the weight of the infusion bag 33 measured over time. Alternatively, a flow meter on the infusion line may be used as the sensing element.

[0208] Finally, although less accurate, the pump speed may be used to determine the flow rate through the infusion line, the speed being monitored through a suitable sensor such as a Hall sensor or a sensor sensitive to an electrical parameter of the pump such as resistance or power consumption.

[0209] 1, the device 1 may comprise a body 37 that rests on the ground and provides a base to house all the components of the device 1, namely the filtration unit 2, the blood circuit, the blood pump 10, the dialysis circuit, the preparation device 13, the metering device 36, the infusion line 34, the infusion pump 35, and the control unit 50. The metering device 36 is a weighing scale and is configured to suspend the infusion bag 33.

[0210] The control unit 50 is housed in the main body 37. The infusion pump 35 and the blood pump 10 are peristaltic pumps supported by the main body 37. Each peristaltic pump includes an actuator or motor (not shown) connected to a rotor. The rotors of the infusion pump 35 and the blood pump 10 are disposed on the front surface of the main body 37.

[0211] The blood circuit and filtration unit 2 is disposable (i.e., disposed of after each blood treatment) and is removably coupled to the body 37. The pump section of the blood removal line 6 is removably coupled to the rotor of the blood pump 10. The infusion line 34 is disposable and is removably coupled to the body 37. The pump section of the infusion line 34 is removably coupled to the infusion pump 35.

[0212] The dialysis circuit is not disposable and is configured to be sterilized after each blood treatment. The tubing, pump and sensors of the dialysate circuit are not configured to be replaced after each treatment, but only for maintenance purposes or in case of failure. The dialysis circuit is therefore integrated in the main body 36 and fixed to the main body 37. The dialysis pump 30 is a positive displacement pump with cross-flow discharge and is mounted in the main body 37.

[0213] The control unit 50 is integrated in or supported by the body 37. The control unit 50 can be connected to the blood pump 10, the metering device 36, the infusion pump 35, the infusion pumps 22, 23, 24 of the regulating device 14, the concentration or conductivity sensors 26, 27, 28, the first flow meter 31, the second flow meter 32, the liquid check mechanism 29, and the dialysis pump 30 of the ultrafiltration device. The control unit 50 controls the metering devices and measures the instantaneous weights, for example with an acquisition frequency of 1 Hz. The control unit 50 is also connected to a display screen 38 (FIG. 1) mounted on the body 37.

[0214] The control unit 50 may comprise a digital processor (CPU) having a memory (or memories), analog type circuitry, or a combination of one or more digital processing units and one or more analog processing circuits. In the present specification and claims, the control unit 50 is indicated as being "configured" or "programmed" to perform steps, which may in fact be achieved by any means that allows the control unit 50 to be configured or programmed. For example, in the case of a control unit 50 with one or more CPUs, one or more programs are stored in a suitable memory and, when executed by the control unit 50, the programs, including programs or instructions, cause the control unit 50 to perform the steps described and / or claimed in connection with the control unit 50. Alternatively, in the case of the control unit 50 being of an analog type, the circuitry of the control unit 50 is designed to include circuitry configured to process electrical signals so as to perform the steps of the control unit 50 disclosed herein, in use.

[0215] The control unit 50 is configured or programmed to receive signals from the sensors and other inputs and to command the pumps and valves according to the signals to perform the blood therapy and administer the infusion product to the patient during the blood therapy. The control unit 50 is also configured or programmed to display data on the display screen 38.

Claims

1. A system (90) comprising an extracorporeal blood treatment apparatus (1) and a remote device (60), the extracorporeal blood treatment apparatus (1) comprising: - a filtration unit (2) having a primary chamber (3) and a secondary chamber (4) separated by a semipermeable membrane (5), - a blood circuit, a blood removal line (6) extending between a first end connected to the inlet of the primary chamber and a second end for connection to a patient (P); a blood return line (7) extending between a first end connected to the outlet of the primary chamber (3) and a second end for connection to the patient (P); A blood circuit comprising: a blood pump (10) for circulating the blood in said blood circuit; a discharge line (12) connected to the outlet of said secondary chamber (4); - a reader (40) for reading the optical pattern (80), a control unit (50) controlling said blood pump and connected to said reader (40); Equipped with The remote device (60) comprises a user interface (61) and a controller (51), enabling input of values ​​for setting parameter values ​​via the user interface (61), where the setting parameter values ​​define settings of the extracorporeal blood treatment device (1) and are associated with an identified patient, the setting parameter values ​​being part of a patient prescription (73) for the identified patient, and the setting parameter values ​​being: the Patient Fluid Removal Rate (PFR) for the identified patient; and Two parameters for the identified patient: total weight loss, total treatment time and ultrafiltration flow rate; At least one of generating an optical pattern (80) encoding said set parameter values ​​(70), said optical pattern (80) being variable depending on said set parameter values ​​inputted; and a controller (51) configured to execute a remote procedure comprising the steps of: The control unit (50) of the extracorporeal blood treatment device (1) comprises: obtaining said set parameter values ​​(70) by reading said optical pattern (80) via said reader (40); - configuring the extracorporeal blood treatment device (1) based on said values ​​of said set parameter values; configured to perform an acquisition procedure including the steps of: system.

2. 2. The system of claim 1, wherein the total weight loss parameter is a function of both the total treatment time and the ultrafiltration rate; WL=UFR・TT and WL = total weight loss UFR = ultrafiltration flow rate TT = total treatment time That is, the system.

3. 2. The system of claim 1, wherein the optical pattern (80) includes image-encoded information including the set parameter values ​​(70).

4. 2. The system of claim 1, wherein the remote device (60) is a portable device defining a body and physically comprising both an input device (63) that allows a user to input the setting parameter values ​​and a display (62) that visualizes the optical pattern (80), and the controller (51) of the remote device (60) is configured to visualize the optical pattern (80) on the display (62).

5. 5. The system of claim 1, wherein the set parameter values ​​(70) include a plurality of instructions for the extracorporeal blood treatment device (1) to subsequently perform an extracorporeal blood treatment on the patient, and the set parameter values ​​(70) include patient information (71) including patient identification information and at least one of the following information: patient age, patient weight, patient hematocrit value, patient gender, and patient associated disease.

6. 5. The system according to claim 1, wherein the set parameter value (70) is: - a dialysis treatment type, including one of ultrafiltration treatment (UF), hemodialysis treatment (HD), hemofiltration treatment (HF), hemodiafiltration treatment (HDF); - a disposable fluid line set type, which indicates the dialysis treatment type; - dialysis filter or filter set type, which denotes a dialyzer type or a disposable set containing said dialyzer type, - an anticoagulation setting for the extracorporeal blood treatment device (1), the anticoagulation being selected from heparin anticoagulation and local anticoagulation; and Presence or absence of blood warmer, A treatment configuration (72) including at least one piece of information among system.

7. 5. The system according to claim 1, wherein the patient prescription (73) includes values ​​of one or more flow rates to be set in the extracorporeal blood treatment device (1), the one or more flow rates being selected from among a blood flow rate, a pre-blood pump (PBP) flow rate, a syringe flow rate, a fresh dialysis flow rate and a substitution fluid flow rate.

8. A system according to any one of claims 1 to 4, comprising: - a disposable component connected to said extracorporeal blood treatment device (1) for the treatment to be performed, a disposable component comprising an identification code for identifying said disposable component, Further comprising: The control unit (50) of the extracorporeal blood treatment device (1) comprises: - reading the identification code of the disposable component, the reader (40) of the extracorporeal blood treatment device (1) identifies the disposable component, the identification code of the disposable component being in the form of a respective optical pattern (80), or a frequency scanner different from the reader (40) of the device identifies the disposable component, the identification code of the disposable component being in the form of a frequency-related signal; By doing so, you can read and - checking the consistency between the identified disposable component and the set parameter values ​​obtained by reading an optical image from a display; - preventing the extracorporeal blood treatment device (1) from being configured based on at least one setting parameter value if the setting parameter does not match the identified disposable component for the extracorporeal blood treatment device (1); 23. The system according to claim 22, wherein the system is configured to perform an integrity procedure including the steps of:

9. The system of claim 8, further comprising a plurality of disposable components coupled to the extracorporeal blood treatment device (1) for a treatment to be performed, - each disposable component is provided with a component identifier that encodes a respective identification code; the set parameter value includes a treatment identifier indicating a dialysis treatment set in the extracorporeal blood treatment device (1), the dialysis treatment being one of ultrafiltration treatment (UF), hemodialysis treatment (HD), hemofiltration treatment (HF) and hemodiafiltration treatment (HDF); the matching procedure includes checking whether the component identifier of the disposable component matches the treatment identifier of the device according to a predefined matching list, the predefined matching list being a list linking a set of component identifiers to a set of treatment identifiers; the compatibility list includes a set of identification codes indicating compatible disposable components for each of the following dialysis treatments: ultrafiltration treatment (UF), hemodialysis treatment (HD), hemofiltration treatment (HF), and hemodiafiltration treatment (HDF); system.

10. 5. The system according to claim 1, wherein the set parameter values ​​(70) include patient information (71) including an identification of the patient, The control unit (50) of the extracorporeal blood treatment device comprises: - associating a patient who is to undergo extracorporeal blood treatment with said extracorporeal blood treatment device (1); - providing the extracorporeal blood treatment device (1) with identification information of the patient from a source different from the optical pattern (80); - checking for a match between the patient's identification information of the set parameter values ​​(70) read via the optical pattern (80) and the identification information related to the patient provided via a source different from the optical pattern (80); preventing the extracorporeal blood treatment device (1) from being configured based on the setting parameter value (70) and issuing an alarm if no match is found between the patient's identity in the setting parameter value and the identity associated with the patient from the information source; configured to perform a cross-check procedure comprising the steps of: system.

11. 5. The system according to claim 1, wherein the acquisition procedure includes a safety procedure comprising the step of checking the validity of the set parameter values ​​acquired by the optical pattern (80), the safety procedure includes checking whether all the configuration parameter values ​​are within a predetermined valid range; If one or more of the setting parameter values ​​exceed the valid range, the safety procedure prevents the extracorporeal blood treatment device (1) from being configured based on the setting parameter values; If one or more of the set parameter values ​​exceed the valid range, the safety procedure includes instructing the extracorporeal blood treatment device (1) to issue an alarm signal, such as an audible alarm signal or an alarm displayed on a display (62) of the extracorporeal blood treatment device (1). system.

12. 5. The system according to claim 1, wherein the control unit (50) of the apparatus (1) and the controller (51) of the remote device (60) are configured to perform the step of pairing the remote device (60) to the extracorporeal blood treatment apparatus (1) based on an authentication code enabling an authorized user to perform the pairing step, - if said pairing step is successful, said acquisition procedure is executed, - preventing the acquisition procedure from being performed or the setting parameter values ​​from being set in the extracorporeal blood treatment device (1) if the pairing step is unsuccessful; system.

13. 5. The system according to claim 1, wherein the remote procedure is performed at a remote distance from the patient and from the extracorporeal blood treatment device (1), and the acquisition procedure is performed at an acquisition distance from the patient and from the device, the remote distance being greater than the acquisition distance; The remote procedure further comprises: remotely at a safe distance from the patient, the safe distance being comprised between 2 meters and 100 meters; and / or - separated from the patient by a barrier, Executed, said barrier and / or said safety distance is configured to separate the user responsible for inputting said setting parameter values ​​(70) into said remote device (60) from said patient in order to avoid the transmission of bacteria and / or viruses between said patient and said user; the acquisition procedure is performed near the extracorporeal blood treatment device (1) and near the patient, and during the acquisition procedure the user in charge of performing the acquisition procedure is at a distance of less than 3 meters from the patient; system.

14. 14. The system of claim 13 in combination with claim 10, wherein the cross-check procedure is performed at a cross-check distance substantially equal to the acquisition distance.

15. 5. The system according to claim 1, wherein the user interface (61) of the remote device (60) comprises both a display (62) and an input device (63) for inputting the setting parameter values, The controller (51) of the remote device (60) - inputting or allowing a user to input one or more further setting parameter values ​​(70) into the remote device (60) via the user interface (61) of the remote device (60), the further setting parameter values ​​including one or more of the following setting parameter values: a patient prescription (73), a treatment configuration (72) and patient information (71); and / or - modifying or updating, or allowing a user to modify or update, via the user interface (61) of the remote device (60), one or more of the configuration parameter values ​​(70) entered during the remote procedure; a local procedure inserted in time between the remote procedure and the acquisition procedure, the local procedure comprising the steps of: the local procedure is performed by a user at a local distance from the patient and / or from the extracorporeal blood treatment device (1), and the remote procedure is performed by a user at a remote distance from the patient and from the extracorporeal blood treatment device (1), the local distance being shorter than the remote distance; the local procedure and the acquisition procedure are performed at substantially the same location relative to the patient and the extracorporeal blood treatment device; system.

16. 5. The system according to claim 1, wherein the acquisition step comprises a verification step temporally following the step of acquiring the set parameter values ​​(70) by reading the optical pattern (80) via the reader (40), The confirmation procedure includes: - displaying one or more of said set parameter values ​​(70) on a display of said device (1); - requesting to receive from a user an approval signal of said one or more of said configuration parameter values ​​(70) received by said device (1); - checking whether said acknowledgement signal has been received; The method includes the steps of: - enabling said step of configuring said extracorporeal blood treatment device (1) based on said values ​​of said configuration parameter values ​​(70) received by said device (1) if said approval signal is properly received by said device; - preventing the step of configuring the extracorporeal blood treatment device (1) based on the values ​​of the configuration parameter values ​​(70) received by the device if the approval signal is not properly received by the device (1); system.

17. 17. The system of claim 16, wherein the requesting step of the verification procedure comprises: - requesting one and only one acknowledgement signal indicating acknowledgement of all said configuration parameter values ​​(70) received by said device (1), or - partitioning the setting parameter values ​​(70) into two or more groups, each group including a respective setting parameter value (70) received by the device (1), and requesting an acknowledgement signal for each group of setting parameter values ​​(70), system.

18. 18. The system of claim 17, wherein the setting parameter values ​​(70) are divided within the groups based on a category of each setting parameter value, and at least one flow rate group is provided that includes only the setting parameter values ​​related to a flow rate for setting the extracorporeal blood treatment device (1).

19. 5. The system according to claim 1, wherein a change in the input setting parameter value corresponds to a change in the optical pattern (80) displayed on the user interface (61) of the remote device (60), the optical pattern (80) being displayed on a display (62) of the remote device (60), the step of displaying the optical pattern (80) on the display (62) being performed during the acquisition procedure and temporally after the remote procedure, and is dependent on successful pairing between the remote device (60) and the extracorporeal blood treatment device (1), and if the pairing is not successful, the remote device prevents the optical pattern (80) from being displayed.

20. A system comprising an extracorporeal blood treatment apparatus, a remote device, and a disposable component coupled to the extracorporeal blood treatment apparatus for a treatment to be performed, the extracorporeal blood treatment apparatus comprising: a filtration unit having a primary chamber and a secondary chamber separated by a semipermeable membrane; - a blood circuit, a blood removal line extending between a first end connected to an inlet of the primary chamber and a second end for connection to a patient; a blood return line extending between a first end connected to the outlet of the primary chamber and a second end for connection to the patient; A blood circuit comprising: a blood pump for circulating blood in said blood circuit; a discharge line connected to the outlet of said secondary chamber; - a reader for reading the optical pattern, a control unit controlling said blood pump and connected to said reader; Equipped with The remote device includes a user interface and a controller, enabling input of values ​​for configuration parameter values ​​via the user interface, where the configuration parameter values ​​define a configuration of the extracorporeal blood treatment device and are associated with an identified patient, the configuration parameter values ​​being part of a patient prescription for the identified patient, and the configuration parameter values ​​being a patient fluid removal rate for the identified patient; and Two parameters for the identified patient: total weight loss, total treatment time and ultrafiltration flow rate; At least one of generating an optical pattern in which the set parameter value is encoded, the optical pattern being variable depending on the input set parameter value; and a controller configured to execute a remote procedure including the steps of: the disposable component includes an identification code for identifying the disposable component; The control unit of the extracorporeal blood treatment device includes: obtaining said setting parameter values ​​by reading said optical pattern via said reader; - configuring the extracorporeal blood treatment device based on the value of the set parameter value; The method is configured to perform an acquisition procedure including the steps of: The control unit of the extracorporeal blood treatment device is further configured to perform a consistency procedure before configuring the extracorporeal blood treatment device based on the value of the setting parameter value, the consistency procedure comprising: reading the identification code of the disposable component, the reader of the extracorporeal blood treatment device identifies the disposable component, the identification code of the disposable component being in the form of a respective optical pattern; or A frequency scanner, distinct from the reader of the device, identifies the disposable component, and the identification code of the disposable component is in the form of a frequency-related signal; By doing so, you can read and - checking the consistency between the identified disposable component and the set parameter values ​​obtained by reading an optical image from a display; o preventing the extracorporeal blood treatment device from being configured based on configuration parameter values ​​if one or more configuration parameters do not match the identified disposable component for the extracorporeal blood treatment device; The steps include: system.

21. A method (1000) for providing configuration parameter values ​​to an extracorporeal blood treatment device (1) for performing an extracorporeal blood treatment, comprising: The method comprises: - providing a remote device (60) equipped with a user interface (61); inputting setting parameter values ​​(70) via the user interface (61) into the remote device (60), the setting parameter values ​​defining a setting of the extracorporeal blood treatment device (1), relating to an identified patient and being part of a patient prescription (73) for the identified patient, the setting parameter values ​​(70) the Patient Fluid Removal Rate (PFR) for the identified patient; and two parameters for the identified patient among total weight loss (WL), total treatment time (TT) and ultrafiltration rate (UFR); and - generating an optical pattern (80) encoding said set parameter values ​​(70), said optical pattern (80) being variable depending on said set parameter values ​​input; a remote procedure that includes the steps of The method comprises: - providing said extracorporeal blood treatment device (1) comprising a reader (40); - displaying said optical pattern (80) on a display (62); - reading the optical pattern (80) displayed on the display (62) by bringing the reader (40) of the extracorporeal blood treatment device (1) relatively close to the display (62); - obtaining said set parameter value (70) via said reading step; The method further includes an acquisition procedure including the steps of The extracorporeal blood treatment device (1) is configured based on the value of the setting parameter value. method.

22. A method as described in claim 21, wherein the optical pattern (80) includes image encoding information including the setting parameter value (70), and the image encoding information includes at least one of a barcode, a QR code, and a steganographic image.

23. The method of claim 21, comprising: - providing disposable components coupled to said extracorporeal blood treatment device (1) for the treatment to be performed; - providing said device with an identification code of said disposable component for identifying said disposable component; Further comprising: The method comprises: - reading the identification code of the disposable component, the reader (40) of the extracorporeal blood treatment device (1) identifies the disposable component, the identification code of the disposable component being in the form of a respective optical pattern (80), or a frequency scanner different from the reader (40) of the device identifies the disposable component, the identification code of the disposable component being in the form of a frequency-related signal; By doing so, you can read and - checking the consistency between the identified disposable component and the set parameter values ​​obtained by reading an optical image from a display; - preventing the extracorporeal blood treatment device (1) from being configured based on at least one setting parameter value if the setting parameter does not match the identified disposable component for the extracorporeal blood treatment device (1); and a consistency procedure including the steps of: method.

24. The method according to claim 21, wherein the set parameter values ​​(70) include patient information (71) including an identification of the patient; The method comprises: - associating said extracorporeal blood treatment device (1) with a patient who is to receive said extracorporeal blood treatment; - providing the extracorporeal blood treatment device (1) with identification information of the patient from a source different from the optical pattern (80); - checking for a match between the patient's identification information of the set parameter values ​​(70) read via the optical pattern (80) and the identification information related to the patient provided via a source different from the optical pattern (80); - preventing the extracorporeal blood treatment device (1) from being configured based on said configuration parameter values ​​(70) and issuing an alarm if no match is found between the patient's identity in said configuration parameter values ​​and the identity associated with said patient from said information source; A cross-check procedure including the steps of: method.

25. A method according to any one of claims 21 to 23, comprising the step of pairing the remote device (60) to the extracorporeal blood treatment apparatus (1) based on an authentication code enabling an authorized user to perform the pairing step, - if said pairing step is successful, said acquisition procedure is executed, - preventing the acquisition procedure from being performed or the setting parameter values ​​from being set in the extracorporeal blood treatment device (1) if the pairing step is unsuccessful; The pairing is based on NFC or Bluetooth protocols, The authentication code includes at least one of a password, a serial number, a fingerprint, and a facial recognition algorithm. method.

26. The method according to claim 21, wherein the user interface (61) of the remote device (60) comprises both the display (62) and an input device (63) for inputting the setting parameter values; The method comprises: - inputting or allowing a user to input one or more further setting parameter values ​​(70) into the remote device (60) via the user interface (61) of the remote device (60), the further setting parameter values ​​including one or more of the following setting parameter values ​​(70): a patient prescription (73), a treatment configuration (72) and patient information (71); and / or - modifying or updating, or allowing a user to modify or update, via the user interface (61) of the remote device (60), one or more of the configuration parameter values ​​(70) entered during the remote procedure; a local procedure inserted in time between the remote procedure and the acquisition procedure, the local procedure having the steps of: the local procedure is performed by a user at a local distance from the extracorporeal blood treatment device (1) and the remote procedure is performed by a user at a remote distance from the extracorporeal blood treatment device, the local distance being shorter than the remote distance; the local procedure and the acquisition procedure are performed at substantially the same location; method.

27. The method according to claim 21, wherein the obtaining step comprises a verification step temporally following the step of obtaining the setting parameter values ​​(70) by reading the optical pattern (80) via the reader (40), The confirmation procedure includes: - displaying one or more of said set parameter values ​​(70) on a display of said device (1); - requesting to receive from a user an approval signal of said one or more of said configuration parameter values ​​(70) received by said device (1); - checking whether said acknowledgement signal has been received; The method includes the steps of: - enabling said step of configuring said extracorporeal blood treatment device (1) based on said values ​​of said configuration parameter values ​​(70) received by said device (1) if said approval signal is received by said device; - preventing said step of configuring said extracorporeal blood treatment device (1) based on said values ​​of said configuration parameter values ​​(70) received by said device if said approval signal is not received by said device (1); method.

28. The method of claim 27, wherein the requesting step of the verification procedure comprises: - requesting one and only one acknowledgement signal indicating acknowledgement of all said configuration parameter values ​​(70) received by said device (1), or - partitioning the setting parameter values ​​(70) into two or more groups, each group including a respective setting parameter value (70) received by the device (1), and requesting an acknowledgement signal for each group of setting parameter values ​​(70), method.

29. A method as described in claim 28, wherein the setting parameter values ​​(70) are divided within the groups based on a category of each setting parameter value, and at least one flow rate group is provided that includes only the setting parameter values ​​related to a flow rate for setting the extracorporeal blood treatment device (1).

Images