EP4069334A1 - Testvorrichtung zum testen von funktionen einer heparinpumpe - Google Patents
Testvorrichtung zum testen von funktionen einer heparinpumpeInfo
- Publication number
- EP4069334A1 EP4069334A1 EP20819694.9A EP20819694A EP4069334A1 EP 4069334 A1 EP4069334 A1 EP 4069334A1 EP 20819694 A EP20819694 A EP 20819694A EP 4069334 A1 EP4069334 A1 EP 4069334A1
- Authority
- EP
- European Patent Office
- Prior art keywords
- pump
- spindle
- test
- syringe
- blood treatment
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Pending
Links
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
- A61M5/142—Pressure infusion, e.g. using pumps
- A61M5/145—Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons
- A61M5/1452—Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons pressurised by means of pistons
- A61M5/1458—Means for capture of the plunger flange
-
- F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
- F04—POSITIVE - DISPLACEMENT MACHINES FOR LIQUIDS; PUMPS FOR LIQUIDS OR ELASTIC FLUIDS
- F04B—POSITIVE-DISPLACEMENT MACHINES FOR LIQUIDS; PUMPS
- F04B51/00—Testing machines, pumps, or pumping installations
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
- A61M5/142—Pressure infusion, e.g. using pumps
- A61M5/145—Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons
- A61M5/1452—Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons pressurised by means of pistons
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
- A61M5/142—Pressure infusion, e.g. using pumps
- A61M5/145—Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons
- A61M5/1452—Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons pressurised by means of pistons
- A61M5/1456—Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons pressurised by means of pistons with a replaceable reservoir comprising a piston rod to be moved into the reservoir, e.g. the piston rod is part of the removable reservoir
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
- A61M1/34—Filtering material out of the blood by passing it through a membrane, i.e. hemofiltration or diafiltration
- A61M1/342—Adding solutions to the blood, e.g. substitution solutions
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
- A61M1/36—Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits
- A61M1/3672—Means preventing coagulation
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
- A61M5/168—Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters ; Monitoring media flow to the body
- A61M5/16831—Monitoring, detecting, signalling or eliminating infusion flow anomalies
- A61M2005/16863—Occlusion detection
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M2205/00—General characteristics of the apparatus
- A61M2205/14—Detection of the presence or absence of a tube, a connector or a container in an apparatus
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M2205/00—General characteristics of the apparatus
- A61M2205/18—General characteristics of the apparatus with alarm
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M2205/00—General characteristics of the apparatus
- A61M2205/33—Controlling, regulating or measuring
- A61M2205/3306—Optical measuring means
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M2205/00—General characteristics of the apparatus
- A61M2205/33—Controlling, regulating or measuring
- A61M2205/332—Force measuring means
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M2205/00—General characteristics of the apparatus
- A61M2205/50—General characteristics of the apparatus with microprocessors or computers
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M2209/00—Ancillary equipment
- A61M2209/02—Equipment for testing the apparatus
Definitions
- Test device for testing the functions of a heparin pump
- the present invention relates to a test device or pump test device according to claim 1. It also relates to a system according to claim 8 and a method according to claim 11. It also relates to a pump according to claim 14 and a blood treatment device according to claim 15 or in each case according to the preambles of the preceding claims .
- Infusion pumps are regularly used to deliver a liquid drug to a patient, for example through a catheter or other access.
- the manner in which the liquid is infused is controlled by the infusion pump, which can have various infusion modes, such as a continuous mode in which the liquid drug is continuously infused at a constant, comparatively low rate, or a bolus mode in which promotes the infusion rate for a short period of time at a comparatively high rate.
- Infusion pumps typically need to be checked prior to delivery to ensure that they are working properly. For this purpose, they are typically connected to a test device and manually caused to convey liquid. This pumping process is typically triggered by a person performing the test by manually activating an input device assigned to the infusion pump, such as a keyboard or a button on a graphical user interface.
- an input device assigned to the infusion pump such as a keyboard or a button on a graphical user interface.
- a system, a Method, a pump and a blood treatment device are specified.
- the object according to the invention is achieved by a test device with the features of claim 1. It is also achieved by a system with the features of claim 8, by a method with the features of claim 11, also by a pump with the features of claim 14 and by a blood treatment device with the features of claim 15.
- test device is provided and suitable to be inserted or used in the syringe holder of a pump, in particular an infusion pump, for example a heparin pump of a blood treatment device. In use, it serves to test at least one function of the pump and / or the blood treatment device connected to the pump.
- a pump which can be checked for correct function by means of the test device according to the invention, has a pump drive and a pump spindle which can be rotated about its longitudinal axis by means of the pump drive (e.g. an electric motor, mostly a stepping motor). Furthermore, the pump has a handle for placing a piston flange of a syringe with liquid medicament thereon.
- the pump spindle which is in rotary connection with the pump drive, is positively and / or non-positively connected to the handle. This connection has the effect that when the pump spindle rotates by means of the pump drive, the handle is shifted in a translatory manner, here up or down.
- a draw tube can be used to transform rotation into translation, or alternatively another element.
- the pump spindle can have a first thread which engages with a second thread of the draw tube.
- the pump also has a so-called handle with a clamping arrangement.
- the clamping assembly includes at least a first spring and two clamps for clamping the plunger flange of the syringe between them. The clamping can take place against the spring force of the first spring.
- the clamping arrangement comprises at least one clamping lever for releasing the clamping.
- the at least one clamping lever is arranged to be actuatable against the spring force. If it is actuated, the two clamps connected to the at least one clamping lever open, for example, and release the piston flange or release it from being clamped.
- the handle serves to hold the piston flange in a form-fitting and / or force-fitting manner. If the piston flange, which is clamped between the clamps of the clamping arrangement of the handle, is moved translationally together with the handle when the pump spindle rotates, this changes the volume of the syringe and the liquid in the syringe is dispensed or applied via the nozzle of the syringe.
- the syringe holder of the pump also has two wings. At least one of the wings has at least one second spring for receiving a portion of a syringe barrel of the syringe between the wings against the spring force of the second spring.
- the pump also has a push button switch or push button sensor in its handle.
- the pushbutton switch is used to check whether the plunger flange of a syringe is inserted into the clamping arrangement or not.
- the test device according to the invention has a holding device.
- the holding device serves to releasably attach the test device at least for the duration during which the pump is checked by means of the test device a surface of the blood treatment device, e.g. B. on an outer wall of their housing to hold.
- the test device has at least one movable actuator and at least one electric motor.
- the electric motor can be, for example, a servo motor, a stepping motor or an electromagnet.
- the electric motor is arranged to move the movable actuator or a section thereof directly or indirectly in a rotary or translatory manner.
- the movable actuator can, for example, be a spindle (with or without the movable draw tube), a rotatable rotary section, a plunger core or the like.
- the system according to the invention for testing at least one function of a pump and / or a
- the blood treatment device has a test device according to the invention.
- the system also has a computer.
- the computer can, for example, be a user computer which is programmed, for example, to read in and / or process inputs made by a user. It can optionally be programmed, the inputs of the user or, z. B. to convert factory default settings into individual test commands or into an entire test scheme with a large number of test commands, or to generate such based on the inputs or default settings. For this purpose, it can be in connection or signal connection with the test device in order to cause it to carry out test activities such as carrying out movements etc.
- a test scheme can also be understood as a test or test "program", test scenario, test case, test or test situation and also be referred to as such.
- the computer can optionally be programmed to the test device individual of the predetermined test commands or the entire predetermined test scheme - z. B. directly or indirectly - to be carried out.
- the computer can also optionally be programmed to have parameters (alternatively: parameter values) transmitted by the blood treatment device or to be read out by the same.
- Parameters can be suitable to reflect the function of the blood treatment device or its pump, for example in the form of error messages, pump parameters, measured values and the like. Measured values can indicate, for example, a delivery rate delivered by means of the pump, an effected delivery rate, the size of a syringe inserted into the pump, and the like.
- the computer is programmed to transmit a test command to a control device of the test device, on the basis of which the spindle drive of the test device rotates the spindle of the test device in a first direction of rotation.
- a section connected to the spindle, in particular a draw tube, is thereby moved in a first direction.
- the computer is programmed to transmit a test command to the control device of the test device, on the basis of which the spindle drive rotates the spindle of the test device in a second direction of rotation around the section connected to the spindle, in particular the draw tube in to move in a second direction, the second direction being opposite to the first direction.
- test command can be aimed at using a first motor and a first actuator of the test device (as examples for the electric motor or for the at least one actuator) at least one of the wings of the syringe holder to the pump about its axis of rotation rotate.
- test command can be aimed at sufficiently actuating at least one of the clamping levers of the pump by means of a second motor and a second actuator in order to thereby decouple the pump spindle from the handle of the pump.
- test command can be aimed at actuating and / or releasing the pushbutton switch, in particular directly or indirectly, by means of an electromagnet (i.e. not actuating it or no longer actuating it).
- the control device is in signal connection with the computer or is prepared for this. You can z. B. receive the aforementioned and / or optionally further test commands (or signals corresponding to these, for example in machine language) from the computer and, if necessary, correspondingly control the motor or motors of the test device.
- the method according to the invention is used to test at least one function of a pump and / or a blood treatment device which is connected to a pump.
- the method comprises the provision of a system according to the invention and the insertion of the test device into the syringe holder of the pump to be tested.
- the method optionally includes the input of at least one test command or a function of the pump or the blood treatment device to be tested by a user via an input device and, if necessary, the assignment of one or more test commands or the entire test scheme with a large number of test commands to this input, e.g. B. by means of the control device, the computer or the input device.
- the method optionally includes activating the blood treatment device in order to cause the pump to operate.
- the method optionally includes the activation of the control device of the test device by means of the computer in order to execute one or more of the test commands generated or transmitted by the computer by means of the following steps:
- Controlling the second motor in order to actuate at least one of the clamping levers by means of the second actuator and / or in order to decouple the pump spindle from the handle of the pump, or vice versa.
- the method optionally includes the interrogation of parameters which describe the operation of the pump from the pump or the blood treatment device, and / or the interrogation or readout of parameters which are used by the
- Blood treatment device can be issued in connection with the operation of the pump.
- Parameters can be e.g. B. measured values, error messages, alarms, status messages, etc.
- the query can take place by means of the computer or by means of an output device of the blood treatment device or the pump.
- the method optionally includes the evaluation of the queried parameters on the basis of predetermined criteria.
- the method optionally includes the outputting of a result of the evaluation by means of an output device, in particular to inform the user and / or to take note of him.
- the pump according to the invention is or was tested by means of the test device according to the invention, the system according to the invention and / or the method according to the invention.
- the blood treatment device according to the invention comprises a pump according to the invention.
- Embodiments according to the invention can have one or more of the features mentioned above or below.
- the features mentioned herein can be the subject of embodiments according to the invention in any combination, provided the person skilled in the art does not recognize a specific combination as technically impossible.
- Embodiments according to the invention are also the subject matter of the subclaims and embodiments.
- Pairing is a process that takes place in connection with computer networks in order to establish an initial link between computer units for the purpose of communication.
- the best-known example of this is the establishment of a Bluetooth connection, by means of which various devices (e.g. smartphone, headphones) are connected to one another. Pairing is sometimes referred to as bonding.
- the object according to the invention has one or more features in a specific embodiment, it is also disclosed herein that the object according to the invention specifically does not have this or these features in other embodiments according to the invention, e.g. B. in the sense of a disclaimer.
- the opposite embodiment for example formulated as a negation, is thus also disclosed.
- the test device has a control device. It is used to control or actuate the at least one electric motor or some or of all of their electric motor (s), multiple motors should be provided. Alternatively, the test device is connected to such a control device. The control of the electric motors, should there be several, can take place jointly, separately, simultaneously or one after the other independently of one another and / or in individual cases, as far as specific motors are concerned, not at all.
- the at least one electric motor is or comprises a spindle drive arranged for direct or indirect rotation of the spindle.
- the electric motor can be a stepper motor or have one that is connected to the spindle, which here is an example of the at least one movable actuator.
- A, preferably rigid, coupling for coupling a motor shaft of the spindle drive to the spindle can be provided.
- the at least one electric motor is or comprises a first motor, in particular a servomotor, which can be provided as an alternative or in addition to the aforementioned spindle drive.
- the first motor can serve as an example of the movable actuator for rotating a first actuator.
- the first actuator can be arranged for direct or indirect rotation of a vane of the pump about the axis of rotation of the vane.
- the at least one electric motor is or comprises, again as an alternative or in addition to the aforementioned, a second motor, in particular a servomotor.
- the second motor is provided for rotating a second actuator as an example of a movable actuator.
- the second actuator has a rotary section with one or more receptacles for shaping and / or force-fit receiving preferably a section of the clamping lever or levers of the section and / or for actuating the clamping lever and / or for decoupling the spindle of the pump from the handle of the pump.
- the receptacles can be designed as slots, projections, steps, depressions, hooks, etc. You can optionally be formed as a negative of the clamping lever or the clamping lever ends.
- the at least one electric motor is or comprises, again as an alternative or in addition, an electromagnet, in particular a lifting magnet.
- the electromagnet preferably has a coil and a plunger core.
- the plunger core can be moved by means of an electromagnetic field that can be generated by means of the coil and is therefore also understood here as an example of the movable actuator.
- the electromagnet is arranged to actuate or release the pushbutton switch, for example directly or indirectly (e.g. by means of a ramp or rocker, a lever or the like) by moving the plunger in one direction or the other.
- the at least one electric motor can thus be understood as an individual motor or as a group of motors, as are particularly listed above, in any combination. The same applies analogously to the at least one movable actuator.
- the spindle of the test device is non-self-locking and / or it is arranged in a non-self-locking manner.
- the spindle is arranged so that it can be rotated without offering any significant resistance to such a forced rotation. If the spindle is rotated differently than by its spindle drive (e.g. by hand), the connection between the spindle and its spindle drive does not prevent or prevent such a rotation.
- a structural design can be achieved, for example, by means of a corresponding coupling and / or a corresponding design of the spindle drive.
- a component which is arranged to be moved translationally by means of a rotation of the spindle (such as the draw tube mentioned herein) is in engagement with the spindle in such a way that the component along the The longitudinal axis of the spindle can be moved (e.g. by hand) - with the spindle itself having to rotate in order to allow the component to move along the longitudinal axis at all - without the spindle offering any appreciable resistance to this movement or its rotation.
- a non-self-locking spindle can thus allow the spindle to rotate and / or the component that is rotationally connected to the spindle to be moved along the longitudinal axis of the spindle, even in the event that the rotation and / or the displacement is not caused by the spindle drive but by others Forces or other motors are effected.
- a non-self-locking spindle can advantageously displace the component that is rotationally connected to it allow even in moments in which the spindle drive is not active and therefore does not cause any rotation itself. Because of its lack of self-locking, the spindle can therefore also permit a "passive" rotation of the spindle, that is not caused by the spindle drive, which rotation is forced by the displacement of the component. “Passive” can be synonymous with conveying by the pump, in which the spindle drive of the test device, but rather the pump drive, moves sections of the test device.
- active can be synonymous with a rotation of the spindle which is caused by the spindle drive.
- An “actively” driven spindle can e.g. B. simulate supposed delivery rates, which are simulated by the activity of the test device.
- control device of the test device is programmed or configured to allow the spindle to rotate in a first direction of rotation by means of the spindle drive.
- control device is programmed or configured to allow the spindle to rotate in a second direction of rotation opposite to the first direction of rotation by means of the spindle drive.
- control device is programmed or configured in order to actuate and / or release the pushbutton switch directly or indirectly by means of the electromagnet.
- control device is programmed or configured to allow at least one of the wings of the syringe holder to rotate about its axis of rotation by means of the first motor and the first actuator.
- control device is programmed or configured to allow at least one of the clamping levers of the pump to be actuated by means of the second motor and the second actuator in order to decouple the pump spindle from the handle of the pump.
- the second actuator is multi-jointed or multi-axis or configured as at least one ball joint or comprises at least one such component.
- the second actuator can consist of several components, two of which, for example, can be designed with each other as a ball joint. In various embodiments, it can have one or more ball joints.
- the ball joints can compensate for the horizontal and vertical differences that arise when the clamping lever is actuated.
- the ball joints can already be produced as a covered ball using a 3D printer, for example, in order to ensure that the ball sits firmly in the joint and still has a lot of freedom of movement, which can benefit the accuracy of the test device.
- control device is or comprises a signal transmission device.
- the signal transmission device is used to transmit the test commands (or a test scheme) generated by a computer to the electric motor of the test device, the computer being configured or provided for generating at least one test command.
- control device is or comprises a Raspberry Pi.
- the computer and / or the control device can be programmed to have a series or sequence of predetermined test commands or test schemes carried out.
- test commands can be stored in a memory device, software and / or a computer program.
- a user can select individual or any combinations from them. He may, for example, only be interested in an occlusion test in which the spindle drive not only does not rotate the spindle, but also blocks rotation by means of the activity of the pump drive and thus simulates, for example, an occlusion of a heparin line connected to a syringe.
- the system further includes a blood treatment device with a pump.
- the test device is designed to slide it on or insert it onto at least one bracket of the blood treatment device, with which it is attached to the housing of the test device
- Blood treatment device can be fixed. Alternatively, it is pushed on, inserted or inserted.
- the test device can be designed in such a way that a form fit, frictional fit and / or force fit is created when it is pushed on. This can preferably be sufficient to hold the test device securely on a syringe holder.
- no further holding devices are preferably necessary.
- additional holding devices can be provided, for example clip and / or latching devices, hook and / or magnetic connections and / or the like.
- the evaluation can include calculating sums, differences, products and / or quotients, checking results or values and / or comparing with expected values or ranges or expected results.
- a plurality of predetermined test commands or test schemes can be executed automatically. This applies to individual test commands as well as to entire test schemes.
- the method according to the invention can already take place during manufacture of the pump or the blood treatment device.
- Blood treatment device has a blood pump and / or is connected to an extracorporeal blood circuit.
- the extracorporeal blood circuit can have a first line, here in the form of an arterial line section, which is in fluid connection with a
- Blood treatment device here by way of example a blood filter or dialyzer
- the blood filter has a dialysis fluid chamber and a blood chamber, which are separated from one another by a mostly semi-permeable membrane.
- the extracorporeal blood circuit also has at least one second line, here in the form of a venous line section. Both the first line and the second line can serve to connect them to the vascular system of the patient.
- CRRT continuous renal replacement therapy
- Blood treatment device for testing correct or deliberately incorrect signals are transmitted.
- further application scenarios or error cases can be simulated and tested, for example a bolus delivery, reverse delivery or the like.
- the test device is able to use the sensors of the pump and / or the
- Manipulate blood treatment device In this way, for example, the insertion of the wrong size syringe or an unauthorized removal of the syringe from the syringe cavity during a blood treatment can be simulated.
- all operating states including all error states can be simulated.
- the reaction of the pump or the blood treatment device to this can be evaluated.
- the simulation of errors with regard to the delivery rate deviation can be particularly important, since only permanent self-control of the delivery rate can guarantee the desired success of the treatment.
- the blood treatment device must "notice” it during a treatment session if its pump is delivering too fast, too slowly, in the wrong direction, or not at all.
- Such wrong funding and closure or blocking scenarios e.g. B. the heparin line, which would have to lead to a standstill alarm, are in some embodiments by the Test device is simulated and the reaction of the device under test or blood treatment device is checked.
- Moving the handle piece at a different speed than would correspond to the delivery rate set on the pump or the blood treatment device can only be made possible by opening the clamping lever and decoupling the handle piece from the spindle or from the draw tube. Without such a decoupling, the handle would be coupled to the spindle of the heparin pump via the draw tube in a forced guidance, which on the one hand would prevent the execution of a series of the test commands mentioned herein.
- some test commands e.g. when testing for occlusion, in which the handle is to be held in place by the test device and prevented from moving
- tensions occur between the components, which could lead to the destruction of the test device or pump.
- the test device is designed in such a way that it can be used to simulate a backward delivery of the pump.
- the test device does not include any measured value transducers, for example for force, pressure and / or displacement.
- the test device does not include a volume accuracy tester.
- the test device does not include an occlusion device by means of which z. B. the lumen of a fluid line would be occluded. In some embodiments, the test device does not include a valve.
- the test device does not cause the pump to perform a delivery behavior and / or does not intervene in its control.
- the test device does not include a hydraulic connection.
- the test device does not include any test liquid.
- the test device does not comprise a fluid line and / or a fluid reservoir, e.g. B. no syringe reservoir for holding a drug.
- the test device is not a syringe, in particular not a disposable syringe.
- the test device does not perform a spindle movement (as an imitation conveying movement) against a spring force.
- the present invention advantageously allows a pump to be tested automatically.
- the at least one electric motor, controlled by the control device can, together with the at least one movable actuator, automatically check at least one function of the pump.
- the present invention advantageously allows a number of different tests to be performed on the pump. In this way it can be determined whether the pump and / or the blood treatment device controlling the pump detects supposed faults which the test device imitates.
- test device according to the invention can be used for testing the hardware and software not only of the pump being tested, but also of the blood treatment device controlling it with regard to functionality and safety.
- Corresponding notes which can also differentiate between the pump and the blood treatment device as the cause of the specific test result, can be used, as can their output z. B. be provided by means of the output device. This also indirectly increases patient safety.
- test device can advantageously imitate the behavior of a real (single-use) syringe so realistically that the control of the pump or the
- Blood treatment device cannot differentiate between real syringe and test device. In this way, both the reaction to the insertion of a supposedly inserted syringe and potential error states of the system can be tested or recognized.
- both a syringe that is conventionally to be inserted for an examination or a test and a hose set used for this purpose can advantageously be replaced by simulation models such as the test device according to the invention. This can help save costs for these components when testing the pump.
- Another advantage of the present invention can be that deliberately induced error states can be evaluated by the software. This can advantageously increase the safety of the blood treatment and, associated therewith, also the patient safety.
- the checking of the chain of effects in which errors can occur that are solely caused by the syringe pump, can advantageously be extended by actually influencing the corresponding components beyond the syringe pump and up to the functioning of the mechanics and sensors of the blood treatment device.
- the hardware and / or software of the blood treatment device can thus also be checked, for example to determine when errors in connection with the pump activity are noticed and how these are communicated.
- test device can be connected to the already existing test setup for the endurance runs. These This enables testing to be carried out more efficiently and more precisely.
- the present invention can advantageously be matched to a program referred to here as TET in order to have test cases run automatically, for example in the form of test schemes.
- TET is a program with which test cases can be automatically simulated under computer control.
- the test schemes and / or scenarios with the associated test commands are written, for example, in a prefabricated Excel sheet.
- the language and form can be based on the Python programming language, but it is preferably also usable for people without programming knowledge.
- FIG. 1 shows an exemplary embodiment of FIG
- FIG. Figure 2 shows an exemplary embodiment of a syringe
- FIG. 3 shows a first embodiment of the test device in a very simplified exploded view
- FIG. 4 shows the test device of FIG. 3 in the assembled state and the syringe pump with syringe trough;
- Fig. 5 shows the test device of Fig. 4 inserted into the syringe well of the pump
- FIG. 6 shows an example of an arrangement with an electromagnet and a ramp of the test device in a section
- FIG. 7 shows the interaction of the first motor from FIG. 3 with one of the blades from FIG. 1;
- FIG. 8 shows a dialysis device according to the invention as part of the system according to the invention
- FIG. 9 shows, in a schematically simplified manner, a system according to the invention in a further embodiment.
- FIG. 10 shows a flow chart of the method according to the invention in one embodiment.
- FIG. 1 shows an exemplary embodiment of a pump 1000, here an example of an infusion pump, here designed for example as a heparin syringe pump 1000, with a syringe trough or syringe holder 1100 (see right).
- the pump 1000 is in accordance with the present invention, since it is assumed at this point that it has been tested by means of the method according to the invention.
- the heparin syringe pump 1000 has a pump drive 1101, connected to a pump spindle 1103, and an in Rotary connection with the pump spindle 1103 standing draw tube 1105.
- the pump 1000 has a syringe holder 1120, which in turn has a left wing 1121 and a right wing 1123.
- the syringe cylinder 2201 of a syringe 2000 here by way of example a heparin syringe as shown in FIG. 2, is received between them.
- At least one of the two wings 1121, 1123 can be rotatably mounted and provided with a return spring. The distance between the two wings 1121, 1123 can thus adapt to the outer diameter of a syringe cylinder 2201 of the heparin syringe 2000 actually received between them. Since the two wings 1121, 1123 clamp the syringe cylinder 2201 between them, they can also be referred to as clamping levers.
- One or both of the wings 1121, 1123 can each have one or more light barriers which are used to determine the diameter of the syringe cylinder 2201 inserted between the two wings 1121, 1123. So a breaker can be provided, which in the case of z. B. two light barriers depending on how far the affected wing 1121 or 1123 had to be rotated around its axis of rotation so that the syringe cylinder 2201 could find space between the two wings 11211123, sometimes only interrupts one, sometimes both or only the other of the two light barriers or darkened.
- the syringe holder 1120 has two brackets 1125, 1127 below the wings 1121, 1123.
- a cylinder flange 2203 of the syringe 2000 (see FIG. 2) is inserted between them and the underside of the wings 1121, 1123.
- 1 also shows a handle 1130 with two clamps 1131, 1133, which each merge into a clamping lever 1135, 1137.
- the two clamps 1131, 1133 are each rotatably mounted and connected to a return spring.
- the two brackets 1131, 1133 have a distance between them. This distance can be increased by means of the two clamping levers 1135, 1137 against the restoring force of the restoring springs, not shown, in that the two clamping levers 1135, 1137 are pressed towards one another. If the distance between the two clamps 1131, 1133 is sufficiently large, the piston flange 2205 (FIG. 2) of the syringe 2000 inserted into the syringe cavity 1100 can be inserted between them.
- the piston flange 2205 is clamped between them when the clamping levers 1135, 1137 are no longer held or moved against the restoring force, but move apart again due to the restoring force, whereby the clamps 1131, 1133 are moved towards one another. The piston flange 2205 is thereby held or clamped between the clamps 1131, 1133.
- a pushbutton switch 1139 can be seen between the brackets 1131, 1133. With the syringe 2000 inserted, it is pressed through the piston flange 2205. The push button switch 1139 connected to a corresponding electronic circuit thus serves as a sensor which checks whether a syringe 2000 is inserted or not.
- the push button switch 1139 is optionally a touch switch which requires a certain force to be actuated.
- Other sensors that are not actuated by force, for example, but z. B. are designed as light barriers, to check the presence of the piston flange 2205 are also encompassed by the present invention.
- heparin administration takes place as set out below.
- a heparin input by means of the syringe 2000 from the pump 1000 is initiated.
- the heparin input follows a setting (flow rate) which can have been set on the heparin pump 1000 or a blood treatment device 5000 connected to it (see FIG. 8), here a dialysis device.
- the pump drive 110 e.g. B. by means of
- Blood treatment device 5000 are controlled according to set specifications, which can be designed as a stepper motor.
- the stepper motor rotates the pump spindle 1103, which due to its rotation the longitudinally displaceable draw tube 1105 (in an up-down direction in FIG. 1), at the lower end of which the handle 1130 is fixed. If the pump spindle 1103 rotates, it indirectly pulls the handle 1130 upwards, ie in the direction of the brackets 1125, 1127 (and against them) or in the direction of the syringe holder 1120 (and against them).
- the distance between the handle 1130 and the syringe holder 1120 is shortened, and that in the handle 1130 as well as in the The syringe 2000 fixed to the syringe holder 1120 is also shortened in that the syringe plunger 2207 is gradually pushed into the syringe cylinder 2201 while releasing heparin via the nozzle 2211 and as a function of the set heparin rate.
- the heparin input is monitored, for example, on the basis of the values of a linear potentiometer, preferably continuously. Both the correctness of the delivery rate and the direction of rotation are checked very carefully.
- the target position of the syringe is calculated in a predetermined time interval (timeslice), for example every 100 ms, depending on the selected syringe type, preferably with an accuracy of 1 m 1, and compared with the actual position detected by the linear potentiometer. If there are deviations beyond a tolerance limit beyond a defined number of timeslices, this leads to error messages and / or the pump is switched off via a protection system.
- Warning messages or alarms occur, for example, in the event of a lack of anticoagulation, incorrect syringe size, missing or emptied syringe, incorrect operator action or unexpected delivery deviation.
- An incorrect operator action is to be understood, for example, as removing the syringe during blood treatment, that is to say not during a required syringe change to insert a full syringe.
- the user is regularly guided through the process of changing the syringe via a menu on the
- a stepper motor, as it is for. B. can be used for the pump drive 1101, can have a fixed stator and a rotatable rotor.
- the rotor can be a permanent magnet, for example.
- the stator can be constructed from surrounding electromagnetic pole pieces, usually coils with iron cores. Targeted control of the coils creates a defined electromagnetic field, according to which the rotor aligns. This causes the rotor to rotate gradually. If the direction of the current flow through the coils is changed, the polarity of the stator is reversed and the stepper motor turns the motor shaft and a pump spindle connected to it by means of a coupling in the opposite direction.
- Fig. 2 shows an exemplary embodiment of a syringe 2000.
- syringe 2000 has a syringe plunger 2207 with a plunger stopper 2209 with a circumferential seal and a syringe neck or syringe head with a nozzle 2211.
- Fig. 3 shows, in a very simplified manner, a first embodiment of the test device 3000 in an exploded view.
- An optional spindle drive 3100 can be seen on the right, which is designed here as a stepper motor by way of example.
- the spindle drive 3100 or its motor shaft is connected to a spindle 3103 via a coupling 3101, which can be rigid.
- the spindle 3103 is threaded into a draw tube 3105, which can move relative to the spindle 3103. If the spindle drive 3100 rotates the spindle 3103 by means of the coupling 3101, it rotates in the drawtube 3105 and, depending on the direction of rotation, either pulls it upwards or pushes it downwards (each based on FIG. 3).
- the spindle 3103 is preferably designed and / or arranged as non-self-locking.
- the draw tube 3105 is, for. B. by means of fastenings 3107 and 3109, preferably connected in a rotationally fixed manner to a carrier 3200, which can also carry an electromagnet 3139 and a ramp 3147 described in more detail below.
- an optional first motor 3300 in particular a servomotor, which can be part of the test device 3000, is shown.
- Servomotors are electric motors that allow the angular position of their motor shaft as well as the rotational speed and acceleration to be controlled. They mostly include a sensor for determining the aforementioned variables.
- the first motor 3300 can with a first actuator 3301, here by way of example a negative of a wing 1121 of the Heparin pump 1000, see Fig. 1, be connected.
- the first actuator 3301 is rotatably connected to the first motor 3300. This arrangement serves to rotate the vane 1121 of the heparin pump 1000 upon request and thus mimics the presence of a syringe, the diameter of which can be determined by means of the light barrier described herein. Different angular rotations of the first actuator 3301 by the first motor 3300 thus imitate syringes of different diameters.
- FIG. 3 shows an optional second motor 3400 and a fastening 3402 with which the second motor 3400 can be fastened to a carrier 3200.
- the second motor 3400 is connected by means of a receptacle 3403 for a lower end of the clamping lever 1135 and a further receptacle 3405 for a lower end of the clamping lever 1137.
- the ends of the two clamping levers 1135, 1137 inserted into them (indicated by dashed lines in FIG. 3) can be pressed towards one another against a spring force. If they are pressed towards one another, the two clamps 1131, 1133 open, see FIG. 1.
- the two receptacles 3403 and 3405 are moved by means of a rotary section 3407 which is connected to a motor shaft of the second motor 3400 in a rotationally fixed manner.
- the two recordings 3403 and 3405 can each with a rotary joint such. B. the ball sections 3409 or 3411 be equipped or connected. These allow the two receptacles 3403 and 3405 to have the position or angular position relative to one another, as shown in FIG. 3, can be maintained even if they are brought closer to each other in a side view by rotating the rotating portion 3407, with which both rotate with them.
- FIG. 3 shows a holder 3500, also referred to herein as a holding device, which serves to hold the aforementioned elements in the assembled state of the test device 3000 (see FIG. 4) and in turn with a housing 5001 of the dialysis device 5000 (see FIG. 8). is connectable.
- a holder 3500 also referred to herein as a holding device, which serves to hold the aforementioned elements in the assembled state of the test device 3000 (see FIG. 4) and in turn with a housing 5001 of the dialysis device 5000 (see FIG. 8). is connectable.
- no further device is provided which would be used to fix the test device 3000 in place on the housing 5001 of the dialysis device 5000 or on the heparin pump 1000.
- the holder 3500 of the test device 3000 on the dialysis device 5000 can have inserts or other receptacles or connections by way of example, by means of which they can be used, for. B. with the bracket 1125, 1127 of the heparin pump 1000 can enter into a positive and / or non-positive connection.
- the holder or holding device 3500 is alternatively or additionally a sufficiently strong magnet.
- FIG. 3 there are two inserts 3501 and 3503 of the holder 3500, into which the brackets 1125, 1127, see FIG. 1, can be inserted through an end face that is open towards the first motor 3300 (with reference to FIG. 3) .
- the inserted state can be seen in FIG. 5.
- the two inserts 3501 and 3503 can be part of the optionally triangular design in a side view Bracket 3500.
- the triangular shape advantageously allows two contact points, which the holder 3500 and the housing 5001 of
- Dialysis device 5000 with each other can be comparatively far apart, which is mechanically favorable for the stability of the test device 3000 in use.
- the triangular shape allows the holder 3500 to weigh as little as possible and / or to require installation space.
- the holder 3500 can be provided as part of the test device 3000. It allows the test device 3000 to be inserted into the syringe cavity or receptacle 1100 of the heparin pump 1000, which sits on the housing 5001 of the dialysis device 5000, at least in sections to imitate a syringe and to be able to hold it stationary on the housing 5001.
- FIG. 4 The assembled state of the components of the test device 3000 shown in FIG. 3 is shown in FIG. 4.
- An exemplary spindle 3103 has a pitch of 5 mm.
- the spindle drive 3100 has, for example, a step size of 0.18 °, which corresponds to 200 steps per revolution in the full step mode and 1600 steps in the micro step mode of the step motor.
- the control of the spindle drive 3100 is preferably not more than 1 ms per motor step.
- the spindle drive 3100 can be designed so that it can be blocked, for example by intervening in its control. If the spindle drive 3100 is blocked, its spindle 3103 cannot, even due to external forces or motors be rotated. If this is the case, the handle 1130 cannot be moved by the pump drive 1101 of the pump spindle 1103. As a result, when attempting to deliver heparin, the dialysis device 5000 would have to recognize resistance based on the lack of conveying movement of the handle piece 1130 and deduce an occlusion.
- the at least one electric motor is thus to be understood as a combination of first motor 3300, second motor 3400, spindle drive 3100 and electromagnet 3139.
- the at least one movable actuator is thus to be understood as a combination of first actuator 3301, second actuator 3401, spindle 3103 and plunger core 3143.
- Fig. 4 shows the test device 3000 of FIG. 3 in the assembled state.
- the test device 3000 is shown in front of the syringe cavity 1100 of the heparin pump 1000 of the dialysis device 5000, immediately before it is inserted into the syringe cavity 1100.
- Fig. 5 shows the test device 3000 of FIG. 4 on the housing 5001 of the dialysis device 5000, inserted in or on the syringe cavity 1100 of the heparin pump 1000.
- Fig. 6 shows an example of an arrangement with an electromagnet 3139 and a ramp 3147 of FIG
- Test device 3000 in a schematically greatly simplified sectional illustration.
- the electromagnet 3139 is used by the test device 3000 to press or actuate the pushbutton switch 1139 of the Handle piece 1130.
- the force that is applied to the pushbutton switch 1139 is here, for example, applied by means of a ramp 3147, that is to say indirectly.
- the test device 3000 can use the electromagnet 3139 or its plunger core 3143 to mislead that - instead of the test device 3000 actually inserted in the heparin pump 1000 - a syringe 2000 has been inserted, which presses the pushbutton switch 1139 by means of its piston flange 2205.
- the electromagnet 3139 of FIG. 6 is configured as a lifting magnet, for example. Other designs and arrangements of an electromagnet are also encompassed by the present invention.
- the electromagnet 3139 has a coil 3141 which surrounds a plunger core 3143.
- the plunger core 3143 is mounted inside a coil support 3145 and can be immersed in it, i.e. H. be pushed in against the restoring force R.
- the restoring force R can be caused mechanically, for example by a spiral spring on the electromagnet 3139 or by a restoring spring in the hinge 3149 of the ramp 3147, as explained in more detail below.
- the plunger core 3143 is drawn into the coil carrier 3145 by the magnetic force M against the restoring force R by the magnetic field of the coil 3141.
- the restoring force R and the magnetic force M are indicated in FIG. 6 by means of arrows. The fact that the magnetic force M must exceed the restoring forces R is illustrated by the longer arrow.
- the plunger core 3143 presses with its end 3146 the optional ramp 3147, which in turn pushes onto the Pushbutton switch 1139 presses. If the restoring force R was overcome by means of the magnetic force M, starting from the coil 3141, the plunger 3143 presses with its end 3146 or the ramp 3147 on the pushbutton switch 1139.
- the pushbutton switch 1139 outputs the signal in this case that it regularly always outputs when a syringe 2000 or its piston flange 2205 is in contact with the pump 1000 during use.
- the ramp 3147 if provided, can be provided and arranged as a force converter, as in FIG. 6, in order to advantageously increase the force that the plunger 3143 exerts, following the law of the lever.
- the ramp 3147 can be rotatably arranged for this purpose and z. B. have a hinge 3149.
- the hinge 3149 or the ramp 3147 itself can exert a restoring force R, e.g. B. designed with a return spring or be sufficiently elastic.
- the restoring force returns the ramp 3147, and thus indirectly also the plunger core 3143, to its starting position when the electromagnet 3139 is again made free of electrical voltage or de-energized.
- the electromagnet 3139 itself does not have to have a reset device, e.g. B. does not have its own spring, which is why it can advantageously be made small.
- the test device 3000 In the assembled state and attached to a heparin pump 1000, the test device 3000 is able to simulate the presence of a syringe 2000 of a predetermined diameter and to check the correct function of the pushbutton switch 1139 and the light barrier (s) of the wings 1121, 1123.
- the test device 3000 is also shown in able to provoke error messages of the dialysis machine 5000 by z. B. the push button switch 1139 is not pressed (any more) or the wings 1121, 1123 are moved contrary to the assumption of the dialysis machine 5000. If the error messages provoked in this way are not received, this can influence the test result.
- the electromagnet 3139 actuates the pushbutton switch 1139 in its energized state
- the electromagnet 3139 must be energized in order to release the pushbutton switch 1139 - for the duration of its energization.
- the push button switch 1139 is therefore only actuated when the electromagnet 3139 receives no current.
- the pushbutton switch 1139 is no longer actuated if and as long as the electromagnet 3139 is connected to the voltage source.
- permanent heating of the pushbutton switch 1139 and thus the development of heat can advantageously be prevented.
- the energy consumption can also be reduced as a result, compared to the alternative described with reference to the figures.
- a heparin input can be simulated by means of the test device 3000 and among other things also functions of the heparin pump 1000 and / or the dialysis device 5000 can be checked, for example the behavior when the thrust of the heparin pump 1000 stops due to the above-mentioned blockage by means of the spindle drive 3100.
- Fig. 7 shows the interaction of the first motor 3300 from FIG. 3 with the wing 1121 from FIG. 1.
- Dialysis device 5000 (also not shown) with the brackets 1125, 1127, which are stationary with respect to the housing 5001, and the wings 1121, 1123, which are also immobile with respect to an up-down movement, but which are rotatable about their axes of rotation.
- the first actuator 3301 optionally designed as a negative of the wing 1121, is placed on the left wing 1121. If this is rotated by means of the first motor 3300, the left wing 1121 detachably connected to it also rotates, specifically about its axis of rotation.
- the first motor 3300 and thus also its motor shaft is optionally not straight here, but rather inclined to the vertical.
- This arrangement advantageously makes it possible to use a sufficiently large motor, the torque of which is sufficient to rotate the vane 1121 against the return spring located inside the vane 1121.
- the slight inclination makes it possible to find space in the limited, available installation space within the syringe trough 1100 even for a comparatively large motor.
- Fig. 8 shows the dialysis machine 5000 as part of the system according to the invention.
- the syringe cavity 1100 already shown in the previous figures can be seen.
- Fig. 9 shows a system 6000 according to the invention in a further embodiment.
- a user A has the option of communicating to a computer 6001 via an input device (not shown in FIG. 9) which functions of the pump 1000 of the blood treatment device 5000 are to be checked by means of the test device 3000.
- the input device can comprise or be, for example, a smartphone or another wireless input device, or an input device of the computer 6001, for example a screen and / or a keyboard.
- the functions to be checked are converted into test commands by the computer 6001.
- TET Teestcase Execution Tool
- the TET is a program with which test cases can be automatically simulated under computer control.
- the test schemes and / or scenarios with the associated test commands are written, for example, in a prefabricated Excel sheet.
- the language and form can be based on the Python programming language, but it can also be used by people without programming knowledge.
- the TET or the computer 6001 in general can communicate with the blood treatment device 5000, for example via a controller area network adapter, also known as CAN adapter for short.
- the CAN adapter can thus be used in conjunction with the TET as an interface between computer 6001 and Blood treatment device 5000 can be understood. It is illustrated in FIG. 9 as a double arrow between the computer 6001 and the blood treatment device 5000.
- variables or parameters can be set, read and / or overwritten. This can also help to simulate error states without the sensors having to be manipulated.
- existing test schemes can be transferred into the TET format by other software, for example by a visualization tool that can be used to influence variables.
- test scheme After the test scheme has been written and stored by means of the TET, it can be entered via an input device, for example the console of the TET
- Blood treatment device 5000 It is then processed automatically and the corresponding test is carried out with it. After all test commands of the test scheme have ended (or even earlier), feedback on the result of the test can be given. If the expected results deviate from the results of the test, it can be recorded, for example, when and / or where the deviation occurred. The results can be logged and / or saved, for example in a text file, so that they can be accessed at any time.
- test commands are transmitted to the test device 3000 via the control device 4000, which can also be a signal transmission device.
- the control device 4000 can be integrated into the test device 3000 and / or be in signal connection therewith.
- the test device 3000 is able to process predetermined test tasks of individual or all motors 3100, 3139, 3300, 3400 of the test device 3000, based on which functions of the pump 1000 and / or the blood treatment device 5000 in connection with their pump 1000 are related to their correct execution must be tested.
- the test device 3000 is designed to return feedback and / or a test result, for example in the form of output signals, to the computer 6001 via the control device 4000.
- the output signals can then be converted again by the computer 6001 into outputs that can be understood by the user A, which are then used as a test result, for example via an output device (not shown in FIG. 9) such as a screen or via a mobile terminal (e.g. a Smartphone).
- the data provided by the blood treatment device 5000 are e.g. B. by means of their output devices (display, log, alarms, etc.) issued findings of interest in order to be able to assess the correct functioning of the blood treatment device 5000 and / or the pump 1000, especially in a (simulated) error situation.
- FIG. 10 shows a flow chart of the method according to the invention for testing at least one function of a pump 1000 and / or a blood treatment device 5000 with a pump 1000 in an exemplary embodiment.
- the procedure here includes the following steps as an example:
- Step S1 represents the provision of a system 6000 according to the invention.
- step S2 the test device 3000 is inserted into the syringe holder 1100 of the pump 1000.
- step S3 it can optionally be determined by means of the computer 6001 which functions of the pump 1000 or the blood treatment device 5000 are to be checked or checked by means of the test device 3000, for example via an input device of the computer 6001 (can be a smartphone, for example ).
- the definition can be made by a user A, for example by clicking, selecting, etc.
- the definition can be predetermined, for example programmed, and / or lead to an automatic sequence of the test. It can be stored / programmed in the computer 6001 or in the control device 4000.
- step S4 the blood treatment device 5000 is activated in order to bring about an activity of the pump 1000 that is to be checked.
- the control device 4000 of the test device 3000 is controlled by means of the computer 6001 in step S5.
- the subsequent cascade is more optional Controls Ol to 06, which can also be understood as test commands, represent the possibilities of joint, separate, simultaneous or successive control of some or all of the motors 3100,
- a test command generated by the computer 6001 can be executed.
- the arrows represent the transfer by means of the blood treatment device 5000 or the pump 1000 or the (possibly automatic) querying of parameters by the computer 6001 after step S6.
- the arrows pointing to the right represent the selection of a different or a next step or test command. It may always be possible to return to one of the previous steps or test commands recursively.
- An example is the supply of the electromagnet 3139 with current or voltage (see 03), for example to check the function of the pushbutton switch 1139 and / or the processing of a signal emanating from the pushbutton switch 1139 by means of the blood treatment device 5000. It can be advantageous, after successful testing of the pushbutton switch 1139 by activating the
- Electromagnet 3139 to then take it off the power again. Accordingly, activation 04 could follow activation 03 here.
- This optional recursion is represented by the arrows that leave the diamonds of controls 01 to 06 to the left.
- Fig. 10 stands for the control of the spindle drive 3100 in order to rotate the spindle 3103 in a first direction of rotation and thus move the carrier 3200 towards the vanes 1121, 1123 of the pump 1000, for example. In this way, conveying can be simulated in accordance with or beyond what is set.
- 05 stands for the activation of the first motor 3300 in order to rotate at least one of the vanes 1121 about its axis of rotation by means of the first actuator 3301.
- the pump 1000 or the blood treatment device 5000 recognizes that, depending on the angle of rotation of the wing 1121, a syringe 2000 with a corresponding diameter, e.g. B. 30 ml, 50 ml etc. is inserted.
- 05 can be understood as an output for checking whether the light barrier correctly matches the syringe diameter imitated by means of the first actuator 3301 indicates what could be displayed by the blood treatment device 5000 or output as parameters by it.
- the optional control 06 stands for the control of the second motor 3400 in order to actuate at least one of the clamping levers 1135, 1137 of the pump 1000 to decouple the pump spindle 1103 of the pump 1000 from the handle 1130 of the pump 1000 by means of the second actuator 3401. This may be necessary in order to separate the handle 1130, in which a position sensor can be present, from its forced coupling with the pump spindle 1103 in order to enable the handle 1130 and its position sensor to be moved solely by means of the pump spindle 3103 according to 01 or 02.
- the optional control 06 can take place in parallel with one or more of the other optional controls 01 to 05.
- Step S6 can be understood as collecting data. This is where values and results from the optional
- step S7 parameters from the
- Blood treatment device 5000 queried or read from this, which describe what activity the pump 1000 after understanding the
- Blood treatment device 5000 performed or which error was detected.
- the parameters can include the results of a comparison that the blood treatment device 5000 optionally performs. Alternatively or in addition, it can be parameters that depend on the
- Blood treatment device 5000 are output in connection with the operation of the pump 1000.
- the parameters can e.g. B. Measured values, error messages, alarms, Status messages etc.
- the query can take place by means of the computer 6001 or by means of output devices of the blood treatment device 5000 or the pump 1000.
- the queried parameters are optionally evaluated on the basis of predetermined criteria which can evaluate the test results and make them understandable for the user.
- the evaluation can include simple mathematical operations such as calculating sums, differences, products and / or quotients.
- the evaluation can be a checking of results or values, for example truth values.
- the evaluation can be a comparison with expected values or results.
- step S9 the evaluation is optionally output to a user, for example via an output device of the computer 6100 or a mobile data device, for example a smartphone.
- step S3 i. H. another input of functions to be checked can be made, which starts the method according to the invention again.
- the method according to the invention can also take place automatically, that is to say without user A intervention.
- the method can start and / or end fully automatically by placing the test device 3000 on the pump 1000 or on the blood treatment device 5000 and thereby, e.g. B. in the presence of a pressure switch on the part of the test device 3000, its connection to the pump 1000 or the blood treatment device 5000 recognizes.
- the test device 3000 can be configured to automatically process a (pre-) determined test scheme with the corresponding test commands and then to transmit the determined results to the computer 6001 or to output them to the user A using its output devices if they are connected to recognized by the pump and carried out the (predetermined) test scheme.
- the present invention also comprises a corresponding programming or configuration of a suitable device or a section thereof.
- Test commands S1 to S8 process steps
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Abstract
Description
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Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| DE102019132946.9A DE102019132946A1 (de) | 2019-12-04 | 2019-12-04 | Testvorrichtung zum Testen von Funktionen einer Heparinpumpe |
| PCT/EP2020/084268 WO2021110747A1 (de) | 2019-12-04 | 2020-12-02 | Testvorrichtung zum testen von funktionen einer heparinpumpe |
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| Publication Number | Publication Date |
|---|---|
| EP4069334A1 true EP4069334A1 (de) | 2022-10-12 |
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| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| EP20819694.9A Pending EP4069334A1 (de) | 2019-12-04 | 2020-12-02 | Testvorrichtung zum testen von funktionen einer heparinpumpe |
Country Status (5)
| Country | Link |
|---|---|
| US (1) | US12429047B2 (de) |
| EP (1) | EP4069334A1 (de) |
| CN (1) | CN114761053A (de) |
| DE (1) | DE102019132946A1 (de) |
| WO (1) | WO2021110747A1 (de) |
Families Citing this family (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| EP4076604B1 (de) * | 2019-12-18 | 2024-05-08 | W.O.M. World of Medicine GmbH | Gehäuseanordnung eines rauchgasfiltrationssystems mit einer integrierten möglichkeit zur flüssigkeitsabscheidung |
| DE102021116994A1 (de) | 2021-07-01 | 2023-01-05 | B. Braun Melsungen Aktiengesellschaft | Förderungsabsicherung bei einer Spritzpumpe |
| CN118128741B (zh) * | 2024-05-06 | 2024-07-26 | 大庆市华尔通电控设备有限公司 | 一种机泵振动监测装置 |
Family Cites Families (12)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| DE4000873C1 (en) * | 1990-01-13 | 1991-07-11 | Asm Anlagen Und Systeme Fuer Medizintechnik Gmbh, 1000 Berlin, De | Testing device for pressure infusion appts. - has measured value pick=up with electronic path measurer for piston and force sensor |
| DE4042101C2 (de) | 1990-12-28 | 1996-09-19 | Medical Support Gmbh | Prüfgerät für Spritzen- und Infusionspumpen |
| DE4220831C1 (de) * | 1992-06-25 | 1994-04-14 | Elektronik Vertrieb Gmbh | Prüfvorrichtung für Druckinfusionspumpen |
| US5254096A (en) | 1992-09-23 | 1993-10-19 | Becton, Dickinson And Company | Syringe pump with graphical display or error conditions |
| US5785926A (en) * | 1995-09-19 | 1998-07-28 | University Of Washington | Precision small volume fluid processing apparatus |
| DE19536823C1 (de) * | 1995-09-20 | 1997-02-20 | Rex Mes Und Simulationstechnik | Prüfvorrichtung zum Ermitteln von Betriebskennwerten des Antriebs einer Dosierpumpe |
| US5943633A (en) | 1996-01-05 | 1999-08-24 | Sabratek Corporation | Automatic infusion pump tester |
| DE102007044413A1 (de) | 2007-09-18 | 2009-03-19 | Fresenius Medical Care Deutschland Gmbh | Verfahren zur Überprüfung und/oder Überwachung der korrekten Funktion einer Zugabevorrichtung |
| US20100250003A1 (en) * | 2008-04-15 | 2010-09-30 | Nieboer Christopher J | Detection platforms |
| BR112013005720A2 (pt) * | 2010-09-09 | 2019-09-24 | S E A Medical Systems Inc | sensor para espectroscopia de imitância, sistemas de espectroscopia de imitância e para acumular e identificar resíduos de medicamentos, métodos método de determinar a identidade e/ou concentração de um medicamento, de acumular e identificar resíduo de medicamento, de determinar a identidade e concentração de um medicamento e para precisamente e automaticamente suprir um medicamento, e, sistema médico totalmente automatizado |
| DE102013004860B3 (de) | 2013-03-21 | 2014-09-04 | Fresenius Medical Care Deutschland Gmbh | Vorrichtung zur Aufnahme einer Spritze in eine Fluidabgabevorrichtung sowie Verfahren hierzu und Verwendung einer solchen Aufnahme |
| DE102018108203A1 (de) | 2018-04-06 | 2019-10-10 | Fresenius Medical Care Deutschland Gmbh | Verfahren zum Kalibrieren einer Spritzenpumpe, Spritzenpumpe und Vorrichtungen |
-
2019
- 2019-12-04 DE DE102019132946.9A patent/DE102019132946A1/de active Pending
-
2020
- 2020-12-02 US US17/780,219 patent/US12429047B2/en active Active
- 2020-12-02 EP EP20819694.9A patent/EP4069334A1/de active Pending
- 2020-12-02 WO PCT/EP2020/084268 patent/WO2021110747A1/de not_active Ceased
- 2020-12-02 CN CN202080084170.6A patent/CN114761053A/zh active Pending
Also Published As
| Publication number | Publication date |
|---|---|
| DE102019132946A1 (de) | 2021-06-10 |
| US12429047B2 (en) | 2025-09-30 |
| CN114761053A (zh) | 2022-07-15 |
| WO2021110747A1 (de) | 2021-06-10 |
| US20220412343A1 (en) | 2022-12-29 |
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