EP3948889A1

EP3948889A1 - Monitoring system for a blood treatment apparatus for monitoring states particularly relevant to hygiene

Info

Publication number: EP3948889A1
Application number: EP20715289.3A
Authority: EP
Inventors: Gerhard Wiesen; Martin Buehner; Maria MILLÁN-GALANTE
Original assignee: Fresenius Medical Care Deutschland GmbH
Current assignee: Fresenius Medical Care Deutschland GmbH
Priority date: 2019-03-25
Filing date: 2020-03-23
Publication date: 2022-02-09
Also published as: US20220181000A1; WO2020193457A1; CN113661546A; DE102019107540A1

Abstract

The present invention relates to a system comprising a blood treatment apparatus (4) and comprising a monitoring system (1000) for monitoring the occurrence of a state (Z_x) (x = 1,…, n) from a group with predetermined states (Z₁,…, Z_n), for which it has been defined or determined in advance that, should these occur, the user of the blood treatment apparatus (4) should wear gloves for the purposes of avoiding contamination or a spread of germs.

Description

description

Monitoring system for a blood treatment device for monitoring particularly hygiene-relevant conditions

The present invention relates to a monitoring system according to the preamble of claim 1 and a system according to the preamble of claim 6. Furthermore, the present invention relates to a digital storage medium according to claim 8, a computer program product according to claim 9 and a computer program according to claim 10.

In the treatment of patients, special attention is paid to avoiding infections between patients treated simultaneously or one after the other in the same clinic or on the same ward. Will be used to treat the

Patient medical equipment such as B.

If blood treatment devices are used, it is important to monitor that they are not a source of infections in future or simultaneously treated patients.

It is the object of the present invention to provide a

Monitoring system for a medical device, in particular a blood treatment device, and a system suitable for monitoring, as well as a digital storage medium, a computer program product and a computer program

propose.

The object of the invention is achieved by the

Monitoring system with the features of claim 1 and solved by the system with the features of claim 6. It is also achieved by means of the digital storage medium with the features of claim 8, the computer program product with the features of claim 9 and the

Computer program with the features of claim 10.

In all of the above and following statements, the use of the expression “can be” or “may have” etc. is to be understood as synonymous with “is preferably” or “preferably” etc. and is intended to explain an embodiment according to the invention.

Whenever numerical words are mentioned here, the person skilled in the art understands them to indicate a numerically lower limit. Unless this is not recognizable to the expert

If there is a contradiction, the person skilled in the art therefore always reads “at least one” or “at least one” when indicating “a” or “an”. This understanding is also encompassed by the present invention, as is the interpretation that a numerical word such as "a" can alternatively be meant as "exactly one", wherever this is technically possible for the person skilled in the art. Both are from the

present invention includes and applies to all numerical words used herein.

When "programmed" or "configured" is used herein, it is also disclosed that these terms can be interchanged with one another.

If the person skilled in the art has doubts, the information "above" and "below" are used herein as absolute or relative spatial information

understand which relate to the orientation of the component in question during its normal use. The monitoring system according to the invention is used to monitor whether during or in connection with the use of a medical device, in particular a

Blood treatment device, a predetermined condition

exists, occurs or is about to occur. If this is the case, one or more actions are automatically initiated by the monitoring system with the aim of

Contribute to patient safety.

Predetermined states are characterized by the fact that for them in advance - z. B. based on experience, legal

Regulations, etc. - it has been established at the factory, by the clinic, the ward or the user of the blood treatment device (mostly medical or nursing staff) that when they occur with the aim of avoiding contamination, cross-contamination (a transfer of germs from a patient to another or from one blood treatment device to another) or

Carrying out of germs from the monitoring system predetermined actions are to be taken or brought about. For this

Conditions can apply that when they occur z. B.

Gloves from the user of the blood treatment device

to be put on or worn, or worn gloves to be changed or taken off. So it can be determined that when such a situation occurs, the user for

pending activities in connection with the

Blood treatment device or other medical device to wear gloves or - z. B. after an activity of the user in which he wore gloves - must be taken off. The predetermined state is defined or circumscribed in advance by means of specific features, as explained further below. Since a number of conditions can arise during the treatment, for which the wearing of gloves may be prescribed, in practice a group of such conditions, i.e. optionally more than just one such condition, is preferably compiled and stored.

In this context, monitoring can alternatively be understood to mean recognizing, further alternatively indicating that such a state has occurred or is about to occur, or combinations thereof.

According to the invention, the monitoring system which is used for such monitoring comprises at least one suitably programmed or configured memory device,

Locking device, receiving device and

Execution device. These devices can be embodied by means of individually present components or implemented in practice in any combination in common components.

The group with the at least one predetermined state is stored in the storage device. For each of these states of the group, at least one predetermined

Signal configuration and at least one predetermined action in response to a signal in this configuration

be assigned.

In addition or as an alternative to each of the states of this group, a

Establishment, description, definition or entry condition of the state must be saved. The terms stipulation, description, definition or entry condition can be used in some embodiments as follows

replace the term "definition" used, and vice versa.

The predetermined states which the group comprises or of which it consists may be states (Zi, ..., Z _n ) related to the use of a blood treatment device.

The determination device is configured to determine that or whether at least one of the conditions defined in the group has occurred. For this purpose, it can optionally have or have at least one suitable sensor

Sensor results from existing sensors, e.g. B. the

Blood treatment device, resort. The

Detection device is further configured to in the event that it detects that one of the defined

States has occurred to send a signal that is assigned to the determined predetermined state, in the embodiment assigned to this state. The

Establishing can be or comprise measuring, comparing, reading out, evaluating and / or calculating.

The receiving device is configured to receive the transmitted signal in each case and, when it is received by means of an execution device, to receive at least one

to initiate predetermined action assigned to the signal.

The execution device is configured, when it receives such a signal from the receiving device, to match the transmitted signal in the storage device, respectively to perform the assigned action.

In this case, the entire group of states (Zi, Z _n ) can also be assigned only one signal and, associated with this, the same action in each case. This can also apply to some of the states from the group (Zi, ..., Z _n ). The signal-action combinations that are assigned to the individual states Z _x from the group (Zi, ..., Z _n ) do not have to be mutually exclusive

inevitably differ from each other.

According to the invention, a system is also proposed that, in addition to the monitoring system according to the invention, a

medical device, especially one

Blood treatment device.

An inventive, in particular digital, in particular non-volatile, storage medium (also referred to here as a carrier), in particular in the form of a diskette, RAM, ROM, CD, hard drive, DVD, USB stick, flash card, SD card or EPROM, in particular with electronically or optically readable

Control signals programmed to a

It is also proposed to program or configure a blood treatment device, which has a storage device, a detection device, a receiving device, and an execution device, for a system according to the invention.

A computer program product according to the invention has a volatile, volatile program code or program code stored on a machine-readable carrier, through which a

Blood treatment apparatus comprising a storage device, a detection device, a receiving device, and a Has execution device, can be programmed or configured to a system according to the invention.

The term "machine readable medium" as used herein

is used, in certain embodiments of the present invention denotes a carrier that contains data or information that can be interpreted by software and / or hardware. The carrier can be a data carrier such as a diskette, a CD, DVD, a USB stick, a flash card, an SD card, an EPROM and the like.

A computer program according to the invention has a

Program code by which a blood treatment device, which has a storage device, a detection device, a receiving device, and an execution device, can be programmed, reprogrammed or configured into a system according to the invention.

According to the invention, a computer program product can be, for example, a product stored on a carrier

Computer program, an embedded system as a comprehensive system with a computer program (e.g. an electronic device with a computer program), a network of

computer-implemented computer programs (e.g.

Client / server system, cloud computing system, etc.), or a computer on which a computer program is loaded, runs, is stored, executed or developed.

According to the invention, under a computer program

For example, a physical, marketable software product can be understood which has a program. Advantageous further developments of the present invention are each the subject of subclaims and

Embodiments.

When an embodiment is mentioned here, it is a purely exemplary one according to the invention

Understand embodiment.

Embodiments according to the invention can include one or more of the features mentioned above and / or below in

have any combination, provided that the specific embodiment is not recognizable as technically impossible to the person skilled in the art.

A predetermined state within the meaning of the present invention can, if recognized by the locking device, be a trigger or trigger for a signal which the

Locking device based on the

Storage device stored for this state

Sends out signal configuration.

A "definition" herein can broadly include a

Description z. B. an observation, a sensor result or a machine behavior (z. B. treatment sequence, read out from control software).

A description can e.g. B. be: "User does not wear

Gloves "," User has approached the blood treatment device ", etc. A machine behavior can e.g. B. be: The control or regulating device (for short: control device) causes the blood treatment to be ended, that pumps are stopped and / or that the Blood treatment device goes into reinfusion, that a "blood leak alarm" has been triggered, that a message such as "patient must be connected" is issued, etc.

A predetermined action can be assigned to each such definition, for example according to an IF-THEN rule (IF, for example, a blood leak alarm is triggered, THEN, for example, the message that gloves must be put on is also issued). This is associated with the definition of the type of signal that triggers the action, namely z. B. a signal that is sent to a

Monitor is transmitted, and this can display a specific, predetermined text as a reference for the user.

Associated with a definition can be that e.g. B. a tick or a marker has been set in software for certain states. In this way, the manufacturer, the technician and / or the user can determine which states that can occur when using the blood treatment device count as a state of the group mentioned herein.

In some embodiments is or includes

Execution device at least one monitor, a screen or a display, configured to display a message corresponding to the signal to the user of the

Treatment device. This monitor can be part of the

Be a blood treatment device, he can be one of these

be a separate monitor.

In some embodiments is or includes

Execution device a hand-held device which is held by the user as intended and / or carried with him. Such handheld devices include smartphones, blackberries, pagers, beepers, clips, pendants, headsets, smart watches or wrist devices, etc.

The execution device can have the receiving device and is preferably in signal connection with the locking device therein.

In some embodiments is or includes

Execution device the control or regulating device of the blood treatment device or a portion thereof. So the control or regulating device can

The blood treatment device can be configured to, upon receipt of a signal which is assigned to one of the predetermined conditions from the group with the hygiene-relevant conditions, as a predetermined action treatment options or

Control options, etc. on the treatment device

block, stop pumps, etc. This intervention by the control or regulating device in the treatment process can continue until the monitoring system detects that the user is wearing gloves, until the user confirms a message, and / or until another, likewise predetermined, circumstance entry .

In some embodiments, the action that the execution device takes upon receipt of the dem

A predetermined state associated signal causes the output of a predetermined information on the

Execution device, e.g. B. the monitor or the display.

Alternatively or additionally, the action is or includes causing a component to vibrate, outputting predetermined color displays, the output of an optical or acoustic alarm, the requirement of confirmation by the user before he z. B. with the use of the

Treatment device or predetermined options of the

Treatment can continue.

The action can further include saving a history. The history can provide information about the times and / or the frequency of occurrence of messages, notes or

Alarms related to conditions from the group

reproduce, in particular stating a weighting, relevance or rating. Such a history can be

Further training of staff and / or quality assurance serve.

In certain embodiments, the following observations or events count as a state: the monitoring system detects that the user is working one after the other on two medical devices, in particular blood treatment devices, which have previously been classified as hygiene-relevant; the monitoring system detects an alarm condition (alarm issued by the density sensor, optical sensor, air sensor, pressure sensor, blood detector, access sensor or other sensor of the blood treatment device); the monitoring system recognizes a predetermined operational sequence step from the

Blood treatment devices such as primers; pending connection of the patient; Increasing the flow by means of the blood pump; Changes in measured pressure; Separation of the patient;

Actuation or selection of a switch; Stopping a predetermined pump; the monitoring system recognizes the entry of the user into a predetermined, the

Blood treatment device at least

partially surrounding zone or that

imminent entry or exit

the same or an upcoming exit by the user.

In some embodiments, the detection device is a sensor, software, routine, program loop or a portion thereof, a camera, a touchscreen capacitance meter and / or a zone monitoring device.

The following statements provide embodiments for the

Implementation of the present invention. In particular, they relate to the definition of predetermined states, e.g. T. with associated actions.

For example, the knowledge that the user is in a certain phase of the can count as a predetermined state (and accordingly be stored as a state in the storage device and its occurrence can be read out, for example, by the locking device from the operating software)

Preparing the blood treatment device for the

upcoming treatment session or during blood treatment has to handle the blood accesses himself. Examples are given below.

A state can e.g. B. when connecting the patient (device is e.g. in priming mode), when disconnecting the

Patients (device is e.g. in reinfusion mode or afterwards), or in special alarm situations in which it is likely that the user has or will have contact with the blood tubes / accesses or other hygiene-relevant components.

For monitoring the connection of the patient, the monitoring device can optionally be configured as follows: The blood treatment device optionally has a menu item on the GUI (Graphical User Interface), there the phase can either be displayed automatically or selected by the user. Accordingly, the

Blood treatment device in "priming mode" or a preparation mode until it is no longer selected.

With automatic detection of the end of this phase by means of appropriate software, the blood treatment device can have a sensor, for example an optical detector (IR) and / or a density detector (ultrasound), which indicates when blood is flowing in the arterial line.

For this purpose, the detector can optionally determine the properties of the fluid contained therein on the arterial or venous tube. Alternatively or in addition, a

Starting / increasing the blood flow (according to a set value or a directly / indirectly measured flow) above a limit value can be used as a criterion, because it is not to be expected that the user will increase the flow before a clean connection of lines. A pressure value in the hose system can therefore also be used, since this naturally depends on the blood flow (rotation of the pump). The transmission of the knowledge that one of these states has occurred, which requires an action, can be provided by the software (e.g. which is used to regulate the

Blood treatment device is provided) are transmitted by signal to the detection or receiving device.

For monitoring the reinfusion of blood after the

Treatment can e.g. B. the monitoring device,

be configured so that the monitoring system recognizes the end of the treatment, for example by the

Blood treatment device recognizes that a prescribed ultrafiltration amount has been withdrawn from the blood or that a predetermined treatment time has expired. For this purpose, the monitoring system can be configured as follows: The

Blood treatment device can have a menu item on the

Monitor, e.g. B. the GUI (Graphical User Interface). There it can be provided to either display the phase (reinfusion phase) automatically or to leave it to the user for selection. Goes the

Blood treatment device on the basis of a user input or automatically in one of these phases, this can be predetermined as a state for which an action and thus also a signal triggered by this action in the

Storage device are stored. The action can consist in outputting a message that gloves must be worn for the next activities on the blood treatment device. Alternatively or in addition, other or further actions are also conceivable. This can be used to monitor the separation of the patient, for example after the so-called reinfusion phase or a dependency phase following reinfusion in which the patient is separated and / or bags etc. are unhooked

Monitoring system can optionally be configured as follows: The blood treatment device can have a menu item on the

Monitor, e.g. B. the GUI (Graphical User Interface). There it can be provided that the phase (for example

Dependency phase) either to display automatically or to leave this to the user for selection. Goes the

Storage device are stored. The action can consist in outputting a message that gloves must be worn for the next activities on the blood treatment device. Alternatively or in addition, other or further actions are also conceivable.

For an automatic start of this phase, the

Blood treatment device have a sensor, for example an optical detector (z. B. IR), a density detector (z. B. ultrasound), etc., which indicates when no or largely no more blood flows in the venous line. The detector on the venous tube can do this

Determine the properties of the fluid in it. Alternatively, a pressure value in the hose system can also be used

can be used because at the end of the reinfusion phase the blood pump is stopped and the pressure in the overall fluid system is equalized. Alternatively or in addition, it can also be recognized that a specified treatment time has expired. This can also be stored as a predetermined state; here, too, it can be assumed that the user will next be the

Disconnect the patient from the patient lines and B. will supply the puncture sites.

For example, it can be programmed not to assume that the patient will be disconnected as long as the optical sensor, e.g. B. for optical density, does not indicate a change from "dark" to "light". It can thus be provided that no message is sent to the user and / or no status is stored for the case that there is no recognizable change in the fluid flowing in the extracorporeal blood circuit (ie also no recognized change in the optical density from "light" to "dark") "or from" dark "to" light "), that is, blood is not displaced by transparent flushing fluid in the direction of the patient's venous needle, and / or no fluid below a specified density, etc. is displayed.

Furthermore, predetermined states can be stored which, when they occur, are likely to cause the user

Has or will have contact with the blood lines / accesses.

In some embodiments it is provided that an action that has already been initiated is reversed or ended in the event that the state should no longer last. This can be programmed, e.g. B. in the event of an alarm as one

predetermined state a notice already displayed on the monitor (e.g. via the GUI), according to which, for example, gloves to put on, wear, change or are to be taken off, no further display Since the alarm case, which is considered a predetermined state, no longer applies, a corresponding notice or other action may no longer be required. The same can apply if z. B. a pump stopped in the context of an alarm condition has started again, the alarm condition thus no longer exists.

Another predetermined condition can occur when an arterial negative pressure alarm (indicates suction of the needle in the vessel) is detected. The monitoring system can optionally be configured as follows: The device has a so-called arterial pressure sensor. This is like that

arranged that it measures the pressure in the area of the tube near the arterial needle (for example between the needle and the blood pump). If this pressure falls below or to a predetermined limit value, this becomes a problem with the

interpreted arterial access. In order to remedy this error state, it must be expected that the user will come into contact with the vascular access or the tubes.

Another predetermined state can occur if a "Venous Access Monitoring Alarm" (indicates loss of the venous needle) occurs. The monitoring system can optionally be configured as follows: The device has a so-called venous pressure sensor. This is how it is

arranged that it measures the pressure in the area of the tube near the venous needle (for example on a venous blood chamber). If, on the basis of this pressure, a disconnection of the needle or a loosening of the connection needle / hose is concluded, this pressure falls below or to or around a predetermined limit value, as is the case e.g. B. Subject of WO 2009/118145 is Al. Alternatively, others can

Method for checking a needle disconnection and its alarm signals can be used as a trigger. In such

It can be moisture sensors at the procedure

Puncture site, such as B. the subject of WO 2011/116943 Al, optical methods, as z. B. the subject of WO 2008/123814 Al, or electrical methods, such as. B. The subject of WO 2003/086505 A1, act. In order to remedy this error state, it must be expected that the user will come into contact with the vascular access or the

Tubing occurs. The disclosures of the foregoing

Documents are hereby made the subject of this disclosure in their entirety by reference. They can in particular serve as examples for the description of predetermined states of the group.

Yet another predetermined condition can occur when a blood leak detector alarm occurs. The

The monitoring system can optionally be configured as follows: The blood treatment device has a so-called blood leak detector. This is a detector that is located downstream of the dialyzer or blood filter on the

Dialysate drain line is arranged and can detect even small amounts of blood. This is usually done optically. The locking device of the invention

Monitoring system can be configured to transmit a corresponding signal when a blood leak is detected, upon receipt of which the execution device triggers or initiates an action (notification, alarm, etc.) assigned to the case of a blood leak. Yet another predetermined condition can occur when an air alarm / microbubble alarm occurs. It may be necessary here for the user to contact the patient

must be disconnected to remove the air from the system. The monitoring system can optionally be configured as follows: The blood treatment device optionally has one or more so-called air detectors. These are detectors that are arranged on a blood line. This is usually done using

Ultrasound, but can also be done using electrical or optical methods. If this hits, it may be necessary for the user to loosen adhering air bubbles, for example by moving the hoses, or even to disconnect the patient. In this case, it can be stored that gloves must be worn. The air alarm / microbubble alarm can be defined as a predetermined state which triggers a predefined signal and an associated action, as stored in the memory device.

Yet another predetermined state can occur when entering a predetermined zone (for example around the blood treatment device) or leaving this zone is recognized by a user or by any person in general. Such a state is comparatively easy to determine by means of methods that allow spatial resolution in order to identify a person located there. Such methods can, for example, include or be based on triangulation (with WLAN, IR, RFID), temperature sensors, cameras, motion detectors, etc. When it comes to putting it into practice, the necessary pre- and facilities (sensors, cameras, etc.) do not have to be

must necessarily be installed on the device, they can also be located elsewhere in the room to be recorded.

For example, a 1 m wide room around the

Blood treatment device around be defined as a zone whose entry (or leaving, since the user may have made his way to the next patient by leaving the zone) is stored as a predetermined state and the detection of which can trigger a corresponding signal.

The defined zone can be symmetrical. she can

be asymmetrical. It can be, for example, 1 m in the direction of the patient's bed, but only 40 cm in the direction of an adjacent blood treatment device.

Markings (optionally removable) can be used in the room

Definition of zones to be used.

Preferably, according to the invention, it is advantageously not always pointed out to the user regardless of the upcoming activities that gloves need to be changed or

are to be taken off, but preferably only on certain occasions, namely when one of the predetermined and thus previously recognized as particularly hygiene-relevant conditions occurs. This restriction to the particularly hygiene-relevant

States can advantageously a) dull the user with regard to information, alarms or other states

Use of gloves for prevention, and b) may help reduce the consumption of (not required) gloves. In some circumstances, however, it may be necessary to ensure a priori that the user is wearing gloves, possibly regardless of which activities are to be carried out directly by him. Such circumstances can e.g. B. dealing with known infectious patients, patients with known colonization by multi-resistant germs, etc.

For such - or other - cases, it may be desirable to check whether the user is wearing gloves. The same applies if you want to check whether the user is e.g. B. has followed an instruction to put on gloves.

For such cases, a, possibly further, predetermined one can be used

State that occurs when it is recognized by the monitoring system that the user is not wearing gloves.

Not wearing the gloves can be done by means of suitable

Sensors that are connected to the locking device or are part of it are recognized, e.g. B.

optically or by capacity measurement, heat sensor, etc.

So z. B. can be recognized by means of a touchscreen whether the user is wearing gloves. This is done, for example, by means of the current flowing over the screen or a capacitive signal. The operation of the touchscreen can differ measurably depending on whether the user wears gloves or not. If the user is not wearing gloves, any action mentioned herein can be considered as the action that is carried out or caused by the execution device when the signal is received.

So z. B. an operation of the blood treatment device, such as the confirmation or termination of an alarm, a

Hint, or already starting the blood treatment, selecting a treatment option, connecting

Lines, etc. then be impossible if that

Surveillance system has recognized that the user has no

Wearing gloves.

The locking device can be part of the

Be blood treatment device, but it can also be part of a (further) device of the monitoring device or an independent element.

The locking device is, or has a, transmitter (Bluetooth, WLAN, etc.) with which it is connected to the

Receiving device, e.g. B. a receiver on the bracelet, can communicate directly or indirectly.

In some embodiments, the locking device is arranged in the room (patient room, treatment room, etc.) or building (clinic, ward, dialysis department, etc.).

In some embodiments, the locking device is configured to be wireless or wired

Connection to communicate with the receiving device. Is the locking device z. B. part of

If the blood treatment device and / or if it uses its components, this can advantageously contribute to the fact that the present invention can be implemented in or on blood treatment devices that are already in use. So it may be sufficient to use the operating software of the blood treatment device by means of, for. B.

inventive computer program to update what

is inexpensive and easy.

This can be the case in particular if the

predetermined condition of a machine behavior

The blood treatment device is in the course of the blood treatment, for example the transition to reinfusion or the like, or if the predetermined state is an alarm state

Is blood treatment device, and if in addition the

Execution device of the monitor of the

Blood treatment device is the appropriate messages such as "Wear gloves!" As an action to the user.

The executive device, in some embodiments, is an alarm device.

In some embodiments, the execution device is or has a monitor.

In some embodiments, the execution device can be worn on the body, preferably on a bracelet and thus close to the glove and / or can be easily seen and / or operated, for example to confirm a message on a monitor or to switch off a vibration alarm or an acoustic alarm Alarms. In addition or as an alternative, the

Execution device can be a clip, a tag, etc.

In some embodiments, the execution device is configured to generate a vibrating alarm, a visual and / or an audible alarm.

A visual alarm can be color-coded (e.g. two colors, e.g. red and green, where red can indicate that the user has something to do). A color coding such as B. the

Use of red light, or light in different

Colors, like - with the possible exception of the pure

Vibration alarms - also other forms of alarm, from one

Outsiders (i.e. a person other than the

responsible user).

Other signals such as different brightnesses, interrupted light versus continuous light, sound

(Volume, frequency) etc. are also possible according to the invention.

In some embodiments, the execution device is configured to output further information in addition to the aforementioned alarm relating to putting on, wearing, changing and / or taking off gloves, e.g. B. by means of the monitor or display that the user z. B. on the bracelet. For this additional information z. B. Count alarms associated with other medical devices.

The execution device can be part of another

medical device, such as another Blood treatment device. It can thus be known which device the user will be working on next.

In some embodiments, the execution device is configured to, upon confirmation of the indication that e.g. B. to put on, wear, or change gloves

must be removed, an alarm for third parties (patients, doctors, other caregivers) to end recognizable by z. B. switches a color marking similar to a traffic light from "red" to "green". In this way, it is also possible for third parties to recognize that hygiene measures are necessary or

were carried out. This advantageously enables the user to be checked by third parties. So even the patient can contact the stressed or inexperienced user

the necessary hygiene measures or the hygiene protocol, which can increase patient safety.

In some embodiments, the monitoring system is configured to keep a history of the behavior of the

Monitoring system, e.g. B. to save their locking device or their execution device. So, to stick with the previous example, e.g. B. the information on how often the color marker was "red", or how long it was "red", or any other type of action can be stored, for example in the memory device. Reading out this storage can then, for example, increase the

Patient safety can be used by the user

based on the stored data with a view to the

Hygiene protocol can be addressed or further training. The storage device used for this can be part of the blood treatment device, part of a clinic server, Station or the like or a stand-alone storage device.

The history can advantageously also be used here in order to assign certain incidents to certain people. For this purpose, it is conceivable that the blood treatment device recognizes the respective user and can assign "his" alarms to him. Several methods are conceivable for this: a) The user must be on the blood treatment device

identify, e.g. B. by active insertion, e.g. B. a chip card; b) the user is automatically recognized by the blood treatment machine, for example by means of RFID, NFC chip, tags, GPS transmitters, cell phone location, barcode recognition,

Face recognition or the like.

Identification devices can be included in the

Blood treatment device can be integrated or configured to communicate with it. An example is face recognition by camera in combination with a

Called device identification. This can be particularly relevant as it can contribute to better monitoring of personnel and thus to quality assurance, especially in the event of a hectic alarm.

In some embodiments, a device is the

Monitoring system, e.g. B. the locking device or the executive device configured to, if of the

Monitoring system it is recognized that the user is leaving the zone, only to carry out an action, and in particular a message is only issued if, in connection with an activity carried out on the blood treatment device, the environment or zone of which the user is about to leave, it was recognized that gloves were worn, which are now e.g. B. take off or change applies. This can be detected in any of the ways described herein, e.g. B. by means of the touch screen of the blood treatment device whose zone the user is about to leave.

In some embodiments, a device is the

Monitoring system, e.g. B. the locking device or the execution device configured as follows: When it is recognized by the monitoring system that the user has performed an activity or action on a first medical device for which the wearing of gloves

is prescribed, but at the same time the monitoring system cannot determine that he was wearing gloves on the first medical device, then by means of the

Monitoring system carried out an appropriate action. For example, it can be pointed out that

Gloves must be worn and / or hand disinfection must be carried out.

The monitoring system can additionally be configured so that the action is only carried out if a second one is carried out according to a stored work plan

Blood treatment device will have to be operated and / or if by means of a detection device, for example a camera or one as described above

Determination device is recognized that a predetermined area is entered around a second blood treatment device.

A treatment device according to the present invention can, but is not limited to, perform a Hemodialysis, hemofiltration, hemodiafiltration or a separation process are suitable and / or

configured.

In some embodiments, the invention is not directed to a blood treatment device, but rather to a

Medical device which, when used, is expected to wear gloves. Such devices can also be treatment devices, but they can also be dialysis devices or serve some other purpose. For these embodiments, what is stated herein about blood treatment devices applies analogously to the medical device. In these embodiments, the terms “blood treatment device” and “medical device” can thus be interchangeable.

In some embodiments, no disinfection state, especially a touchscreen (or a

Touchscreen sensors), monitored or recorded. Preferably there is no signal that the disinfection status of the

Touchscreens (or a touchscreen sensor).

Preferably, the invention does not relate to or encompass any system or device that is used for monitoring the

Disinfection state and / or the output of such a signal would be programmed.

In some embodiments, no

Disinfection state vector created. Preferably, the invention does not concern or encompass any system or none

Device used for creating a

Disinfection state vector would be programmed. In some embodiments there is no provision for disinfecting a touchscreen, a touchscreen sensor or a touchscreen capacitance meter. Preferably, the invention does not relate to or encompass any system or device that would be programmed to disinfect the touch screen, touch screen sensor or touch screen capacitance meter.

One or more of the advantages mentioned herein can be achieved by means of some embodiments.

One advantage of the invention is that it is very easy to implement. So it may be possible to use a

conventional blood treatment device simply by a software update to one according to the invention

Retrofit blood treatment device. The output of information or glove alarms, for example on the user's smart phone carried in the pocket, or the room alarm or machine alarm via vibration alarm or by means of an alarm or ring tone reserved for this purpose, can be implemented without significant technical effort.

The present invention can contribute to a

To advantageously avoid the spread of germs between patients or between blood treatment devices or at least to reduce their risk. This advantage is likely to come into play especially for inexperienced users.

In addition, the present invention allows, within a clinic or ward and even within one

Patient room with more than one patient,

to follow different hygiene protocols. So it can be provided a first monitoring device for Monitoring a first patient (or a first

Blood treatment device) to a first group of

To have access to states is a second

Monitoring device for monitoring a second

Patient (or a second blood treatment device) to a second set of conditions. Both the first

Blood treatment device and the second

Blood treatment devices can be used in the same ward or in the same patient room.

Do the states differ on which theirs

Execution devices each access one another, so they instruct the users of these two

Blood treatment devices on different behaviors associated with the use of gloves. Such a use of the present invention can offer advantages above all if more possible from the point of view

Carry-over of germs harmless patients together with highly problematic patients with regard to their germ load

Patients (MRSA or other (multi-) resistant germs) can be treated in one room, on a ward, etc.

At the same time, the present invention can contribute to reducing the consumption of gloves to a reasonable level, if the conditions are appropriate

are selected.

The present invention is explained below by way of example with reference to the accompanying drawing, in which the same reference symbols denote the same or similar components. In the figures: 1 shows schematically simplified sections

one according to the invention

Blood treatment device with a

monitoring system according to the invention in an exemplary embodiment;

Fig. 2 shows an inventive

Monitoring system roughly simplified as

Diagram; and

Figs. 3a to 3c show examples of the occurrence of a

predetermined state.

Fig. 1 shows an extracorporeal blood circuit 1, which for a treatment by means of double-needle access, or using, for. B. an additional Y-connector, by means of single-needle access, with the vascular system of the not

presented patient would be connected. Of the

Blood circuit 1 is optionally available in sections thereof in or on a blood cassette 2. This blood cassette 2 is optionally designed so that it can also be used in other types of treatment, for example a single-needle treatment.

Pumps, actuators and / or valves in the area of the

Blood circuit 1 are equipped with an inventive

Blood treatment device 4 or with a control and / or regulating device 29, which has an inventive

Monitoring system 1000, or parts thereof, have or can be connected to it in signal communication,

connected. The monitoring system 1000 includes a

Locking device 200 or is with such in Signal communication connected. The locking device 200 can be a camera, for example.

The blood circuit 1 has an arterial

Patient hose clamp 6 and an arterial

Connection needle 5 (as an example of an access device) of an arterial section or an arterial

Patient line or blood collection line 9 on. Of the

Blood circuit 1 also has a venous

Patient hose clamp 7 and a venous connection needle 27 (as an example of a further or second access device) of a venous section or a venous patient line or blood return line 23.

A blood pump 11 is provided in the arterial section 9, and a substituate pump 17 is connected to a substituate line 17a. The substituate line 17a can be connected to a substituate source by means of a, preferably automatic, substituate port 18. Using the

The substituate pump 17 can supply substituate by pre-dilution or by post-dilution via associated lines 13 or 14 in

Line sections, for example in the arterial

Section 9 or into a venous section 23a (between a blood chamber 19a of a blood filter 19 and a venous air separation chamber 21) of the blood circuit 1.

The blood filter 19 has the blood chamber 19a connected to the arterial section 9 and to the venous section 23a. A dialysate chamber 19b of the blood filter 19 is connected to one leading to the dialysate chamber 19b

Dialysis fluid supply line 31a and one of the Dialysate chamber 19b connected away dialysate drain line 31b.

The dialysis fluid supply line 31a optionally has a valve V24, by means of which the flow within the

Dialysis fluid supply line 31a can be prevented. The dialysate drain line 31b optionally has a

Valve V25, by means of which the flow within the

Dialysate discharge line 31b can be prevented.

The dialysis fluid supply line 31a is also

optionally connected to a compressed air source 26 by means of a further, machine-internal valve. The

Compressed air source 26 can be part of the

Treatment device 4 or separate therefrom

exist. Downstream of the compressed air source 26 can be a

Pressure sensor 37 may be provided.

1 also shows an arterial air-blood detector 15, a venous substituate-blood detector 25 as well

Pressure sensors 33a, b. You can from the

Locking device (200) can be used.

Fig. 2 shows a monitoring system 1000 according to the invention for monitoring the occurrence of a particular one

State (Zi, ..., Z _n) roughly simplified as a diagram. The arrows (denoted by B to F, F 'and U) indicate data streams which are necessary for the above-mentioned monitoring by the monitoring system 1000 according to the invention. The data can be transmitted via electronic connection, cable or wirelessly. The division of the individual devices 100, 200, 300, 400 is purely exemplary. They can each also be integrated into the blood treatment device 4 or another medical device either alone or in groups. Any connected combinations of the individual devices 100,

200, 300, 400 in separate housings or each device individually conceivable. The invention also encompasses some or all of the devices 100, 200, 300, 400 as

Provide software implementations.

The monitoring system 1000 includes a

Storage device 100, in which there are definitions or descriptions of previously established hygiene-relevant

States Zi, ..., Z _n , here as an example in tabular form. For each state Z _x (x = 1, ..., n) at least one corresponding signal S _x and at least one corresponding to the signal S _x

Assigned to action A _x . It is possible to use the table den

To be supplemented with further data accordingly. It is also conceivable to use the

To update, change and / or expand data stream A with data from blood treatment device 4, for example also in order to store a history as discussed above. The monitoring system 1000 also has a

Detection device 200, which based on the data available via the data stream C, for example sensor or treatment data of the

Blood treatment device 4, taking into account the states stored in the storage device 100

various operations, as explained above, can determine whether a hygiene-relevant state Z _x from the group Zi, ... Z _n is present. In the simplest case, this is done using Comparison of the stored states Z _x (x = 1, ..., n) with an actual situation.

If this is the case, the determining device 200 sends the determined state Z _x via the data stream F

assigned signal S _x to a receiving device 300. This now forwards the assigned to the signal and here via the

Action A _x read out from the data stream F '(via the data stream B) by means of an execution device 400, here for example a display or another

Communication device of the blood treatment device 4, an armband, a cell phone, a tablet, a pager, a beeper, etc. for the user's knowledge.

Fig. 3a shows an example of the occurrence of a predetermined state Zi and the interaction of the

Blood treatment device 4 at which state Zi occurs, with a hand-held device as an example

Execution device 400.

In the example of FIG. 3a, the

Blood treatment device 4 at least the

Locking device 200 and optionally also further components of the monitoring system 1000 mentioned herein.

The execution device 400 of the monitoring system 1000, on the other hand, in the example in FIG.

In the left illustration of Fig. 3a is of the

Detection device 200 no condition recognized that belongs to the group the predetermined states Z _x counts. There is therefore also no signal that would lead to the predetermined action.

However, this changes shortly afterwards, which is indicated by the arrow between the left and right representation in FIG. 3a.

The illustration on the right shows that the

The locking device 200 has now recognized the state Zi from the group of predetermined states. This state can be, for example, a blood leak alarm, for which it is stored that fresh gloves are to be worn by the nursing staff in response to this. As a result of that

If this condition occurs, then on the handheld device of the nursing staff z. B. a reference as an example of an action Ai assigned to the state Zi, such as the fact that the gloves are to be changed.

Fig. 3b shows another example of the occurrence of a further predetermined state Z2 and the interaction of the blood treatment device 4 at which state Z2 occurs, again with a hand-held device as an example of an execution device 400.

Unlike in the example of FIG. 3a, the

Blood treatment device 4 at least the

Detection device 200 of the monitoring system 1000 does not appear. The locking device 200 is rather a for

Blood treatment device 4 external device, here by way of example a camera or zone monitoring device. You can, as indicated in Fig. 3b, above the

Blood treatment device 4 and / or a patient bed next to the blood treatment device 4 and z. B. monitor a zone indicated by the broken lines and the circle 50 according to predetermined criteria for the occurrence of one of the predetermined states.

The predetermined state Z2, which the camera recognized in the transition from the illustration on the left to the illustration on the right in FIG.

If the predetermined state Z2 occurs, then as

assigned action A2 on the handheld device of the nursing staff z. For example, a notice will now be issued that the gloves previously worn must be changed or discarded.

Fig. 3c shows yet another example of the occurrence of a further predetermined state Z3 and that

Interaction of the blood treatment device 4, at which state Z3 occurs, again with a hand-held device as an example of an execution device 400.

Unlike in the examples in FIG. 3a or 3b, the blood treatment device 4 has only part of the

Locking device 200 of the monitoring system 1000.

The locking device 200 is here as a combination of devices, for example for

Blood treatment device 4 count, and devices that are external to the blood treatment device 4 as here

to understand the camera or zone monitoring device of FIG. 3b as an example.

The detection device 200 divided in this way must, in order to be able to determine that a predetermined state occurs, both Detect a partial state Z3 by means of the zone monitoring device and a further partial state Z3 'by means of the blood treatment device 4. Only when both

Partial states are considered to have occurred

Nursing staff a note or the like, which is referred to here as assigned action A3. This can, purely

exemplary, the above Action A2 correspond, which, however, is only required when the treatment device 4 z. B. it was found that the patient's vascular access was established (partial state Z3 ') and the nurse

then left zone 50 or wanted to leave (partial state Z ₃₎ .

Actions can thus be understood as a response to a combination of states, all of which must occur in order to trigger the specific action.

Individual states can also lead to a combination of actions. So z. B. when recognizing a

Blood leak alarm not just an indication of the handheld device

be sent (as a first action of the combination of actions), but also an alarm sound on

Blood treatment machine sounding (as a second action of the combination of actions).

Reference character list

1 extracorporeal blood circulation

2 blood cassette

4 blood treatment device

5 access device,

for example arterial connection needle

6 arterial patient hose clamp

7 venous patient hose clamp

9 arterial section or

arterial patient line or

arterial blood collection line

11 blood pump

13 Addition point for substituate (predilution)

14 Addition point for substituate (post-dilution)

15 arterial air-blood detector

17 conveying device, for example substituate pump 17a substituate line

18 automatic substituate port

19 blood filters

19a blood chamber

19b dialysate chamber

21 venous air separation chamber

23 venous section or venous patient line or venous blood return line

23a venous section

25 venous substituate blood detector

26 compressed air source

27 access device,

for example venous connection needle

29 Control or regulating device

31a dialysis fluid supply line 31b dialysate drain line

33a pressure sensor

33b pressure sensor

35 single needle valve

36 single needle chamber

37 pressure sensor

50 zone

100 storage device

200 locking device

300 receiving device

400 execution device

1000 monitoring system

Z _l , Z hygiene-relevant conditions

Sl, ..., S signal configurations A _l , ..., A actions

B data stream

C data stream

D data stream

E data stream

F, F 'data stream

U data stream

V24 valve

V25 valve

Claims

Expectations

1. Monitoring system (1000) for monitoring the occurrence of a state (Z _x) (x = 1, ..., n) from a group of one or more predetermined states related to the use of a blood treatment device (4)

(Zi,, Z _n) , for which it was previously defined or determined that upon their occurrence with the aim of

Avoidance of contamination, cross-contamination or the spread of germs from the

Monitoring system (1000) predetermined actions (A _{x) are} to be taken or brought about, the monitoring system (1000) comprising: a memory device (100) in which the group of the predetermined states (Zi, ..., Z _{n) is} stored , and in which for each of these states (Zi, ..., Z _n) at least one predetermined configuration

Signals (Si, ..., S _n) and for each of these states (Zi, ..., Z _n) at least one

predetermined action (Ai, ..., A _{n) in} response to the signal (Si, ..., S _n) in this

Design are assigned; a determining device (200) configured to determine that or whether at least one of those included in the group

States (Zi, ..., Z _n) has occurred, and further configured to generate a signal (S _x) that corresponds to the detected State (Z _x) from the group is assigned to be sent in the assigned configuration; a receiving device (300) configured for receiving the transmitted signal (S _x) and for causing a predetermined, this signal (S _x) associated with the action (A _x) by means of an execution device (400); and the execution means (400) configured for executing the the transmitted signal (S _x) associated with _the action (A _x) upon receipt of the transmitted signal (S _x).

2. Monitoring system (1000) according to claim 1, wherein the execution device (400) has a monitor, screen or display for displaying a message corresponding to the signal (S _x) to the user of the blood treatment device (4); and / or a hand-held device which the user holds and / or carries with him as intended; and / or a control or regulating device (29) of the

Is or has blood treatment device (4).

3. Monitoring system (1000) according to claim 1 or 2, wherein the action (A _{x) is} one or more of the following Actions is:

Outputting a predetermined information on a monitor, screen or display for the user;

Triggering a vibration alarm, an optical and / or an acoustic alarm;

Output of a note in, preferably multicolored, color representation;

Requesting confirmation from the user; and

Saving a history that shows the times and / or the frequency of occurrence of messages, notices or alarms in connection with states (Zi, ..., Z _n) from the group.

4. Monitoring system (1000) according to one of the preceding claims, wherein one or more of the following states applies as state (Z _x) : the monitoring system (1000) recognizes that the user has a predetermined, the

Blood treatment device (4) leaves at least sections of the surrounding zone (50); the monitoring system (1000) recognizes that the user is one after the other first on a first and then on a second in advance as

medical device classified as relevant to hygiene, in particular is or will be active on blood treatment devices (4); the monitoring system (1000) recognizes a defined alarm condition; the monitoring system (1000) recognizes a defined operating sequence step on the blood treatment device (4); the monitoring system (1000) detects that the user is not wearing gloves; and the monitoring system (1000) detects the entry of the user into a predetermined one

Zone (50) surrounding at least some sections of the blood treatment device (4).

5. Monitoring system (1000) according to any one of the preceding claims, wherein the detection device (200) is or comprises: software or portions thereof; and / or a camera; and / or a sensor (15, 25, 33a, 33b, 37); and / or a touchscreen capacitance meter; and / or a zone monitoring device.

6. System with a blood treatment device (4) and with a monitoring system (1000) according to one of the

previous claims.

7. The system of claim 6, wherein the

Blood treatment device (4) for performing hemodialysis, hemofiltration, a

Hemodiafiltration or a separation process is configured.

8. Digital storage medium, in particular in the form of a floppy disk, CD or DVD or EPROM, with electronically readable control signals, configured to a

Blood treatment device, which a

Storage device (100), a

Locking device (200), a

Receiving device (300), and a

Execution device (400) has or is connected to it in signal communication to configure a system according to claim 6.

9. Computer program product with one on one

program code stored in a machine readable carrier configured to be a blood treatment device comprising a storage device (100), a

Locking device (200), a

Receiving device (300), and a

10. Computer program with a program code to a

Blood treatment device, which a

Storage device (100), a

Locking device (200), a

Receiving device (300), and a