MXPA06004785A - Improved priming, integrity and head height methods and apparatuses for medical fluid systems - Google Patents

Abstract

Improved integrity test, priming sequence and bag height detection tests, apparatuses and methods for a medical fluid delivery system are provided. The integrity test includes a plurality of air pressure decay tests, using positive and negative pressure. The priming sequence includes pumping fluid through a portion of a patient line to be primed to overcome air in the line and other potential obstacles. The head height test measures a pressure build-up or drop-off within a pump chamber of a membrane pump. The measured pressure corresponds to a head height between a fluid supply and the pump or between the pump and a fluid drain. A determination is made whether the corresponding head height is acceptable.

Description

IMPROVED METHODS OF PRIMING. INTEGRITY AND HEIGHT ON THE HEAD AND APPARATUS FOR MEDICAL FLUID SYSTEMS PRIORITY CLAIM This application claims the benefit of the provisional US patent application no. 60 / 515,815 filed on October 28, 2003, entitled "Improved Methods of Priming, I ntegrity and HEIGHT ON THE HEAD and Apparatus for Medicinal Fluid Systems", which is incorporated herein by reference. BACKGROUND OF THE INVENTION The present invention relates generally to medicinal fluid systems and more particularly to testing and priming of those systems. It is known that in periotoneal dialysis systems the performance of integrity tests that aim to verify that there are no leaks in the numerous valves for fluids in a disposable cartridge, that there is no leakage between the multiple pump chambers in the cartridge, that the leakage is not intended through the fluid paths, and that an insulation shutter, which is intended to stop the flow of liquid in the fluid lines connected to the cartridge in the event of system malfunction, by performing this method of appropriate form. In a wet leakage test described in US Pat. No. 5,350,357 a disposable cartridge is loaded into a dialysis cyclizer and the bags with solution are connected. The test consists of the following stages: (i) A decay test is performed on the negative pressure of the fluid valve diaphragms; (ii) A decay test is performed on the positive pressure of the fluid valve diaphragms; (iii) A decay test is performed on the positive pressure in the first pump chamber, while a negative pressure test is performed on the second valve pump; (iv) A decay test is performed on the negative pressure in the first pump chamber, while a positive pressure test is performed on the second valve pump; after which (v) both pump chambers are filled with a measured volume of fluid, all those valves are opened and the shutter is closed, the positive pressure is applied to both pumping chambers for a period of time, after which the volume of fluid in each pumping chamber is measured again to determine if some fluid has leaked through the obturator. As indicated, the above test procedure is performed after the solution bags are connected to the peritoneal dialysis system. If the integrity of the cartridge or tubing is poor, the sterility of the solution bags is compromised. In such a case, both the disposable cartridge and the solution bags have to be discarded. Additionally it is possible that the liquid from the solution bags can be sucked into the pneumatic system of the machine, causing the pneumatic system of the machine to malfunction.

Wet tests are also susceptible to false fire. In particular, the cold solution used in the tests causes many alarms in the integrity tests discarded each year because the tests fail when a shutter, which is supposed to close all the fluid lines, does not close or properly seal the piping lines. When the solution is cold, the pipe assembly is cooled to a lower temperature than the pipe would have if it were placed at room temperature. The cold pipe is more difficult to close, allowing the fluid in some cases to leak past the plug and cause the test to fail. Once you start dialysis therapy, the fluid that passes through the tubing is heated to approximately 37 ° C, allowing the obturator. work satisfactorily It is therefore desirable to have an integrity test that is performed before the solution bags are attached to the therapeutic machine and to eliminate the use of cold solution to prevent false triggering. A "dry" test is briefly described in U.S. Pat. No. 6, 302,653. The description is partially based on the "DRY TEST" implemented in the Baxter HomeChoiice® cycler in December of 1,998. The current tests implemented in the Home Choice® cycler consist of four stages, the first of which occurs before the bags of solution connect. The next three stages require the solution bags to be connected but it is not required to remove fluid from the bags to the machine. Figures 1 to 4 illustrate the areas of a fluid cartridge examined by the individual stages of the known "dry" test. While the previous "dry" test eliminates the problem of potentially leaking fluid in the pneumatic system of the machine, the test does not prevent potentially compromising the sterility of the bags after a leak and so is now discarded if compromises the integrity of the disposable cartridge. In addition, air-dry tests are believed to be more sensitive than wet tests, which use dialysis fluid. Therefore, it would also be desirable to have an identity test using air for reasons of sensitivity as well as for the reasons described above. Although the problems of integrity represent a problem for the manufacturers of machines for medicinal fluids, another common problem is the priming of the fluid system within those machines. In many cases, air must be purged from one or more pipes for safety purposes. For example in the field of dialysis, it is imperative to purge air from the system, such that the peritoneum or veins and arteries receive dialysis fluid that is free of water.

Consequently, automatic dialysis machines have hitherto been provided with priming systems. In peritoneal dialysis, the purpose of priming is to push fluid to all ends of the line, where the patient's connector is located that connects to the patient's transfer equipment, without priming fluid beyond the connector allowing the fluid to flow of the system. Typically dialysis machines have used gravity for priming. The known systems primed by gravity have many disadvantages. First some priming systems are designed for bags of a specific size. If bags of other sizes are used, the priming system does not work properly. Second, in many systems, a mixture of fluid air in the patient's line near its proximal end near a cartridge or cassette may be present at the start of priming. The fluid is sometimes collected in the cartridge due to installation and / or integrity tests. This collection of fluid can cause air spaces between the fluid and the incoming priming solution. Air spaces can prevent and sometimes prevent gravity priming. In fact, many procedural guidelines include a step of tapping a portion of the patient line when the line does not appear to be priming properly. The light tapping has the intention of undoing the air bubbles that are trapped in the fluid line. A third problem that occurs relatively frequently during priming is that the patient forgets to remove the clamp on the patient's line before priming that line. The clamp on the line will not allow the line to prime correctly. An alarm is needed to specifically inform the patient that the patient needs to remove the clamp from the patient's line before proceeding with the rest of the therapy. Fourth, if shields are placed on the vent tips at the end of the patient's line, the vent tips may not properly ventilate and prevent priming. Again an alarm is needed to inform the patient that the line has not been primed properly. Fifth, cost is always a factor. In addition to providing a method and apparatus that solves the above problems. It is also desirable to use existing components to perform the priming, it is possible to avoid having to add additional components and additional costs. Another concern of fluid medical systems and in particular automated peritoneal dialysis ("APD") systems is to ensure that the solution bags are placed at a height relative to the machine that is suitable for the machine to operate within the parameters designated. The height of the solution bags, such as dialysate bags, lactate bags and / or dextrose bags, needs to be monitored to ensure that the proper amount of fluid will be pumped to the patient during therapy and that the amounts and amounts will be infused. correct proportions of additives. Two patents that describe the determination of the position of the stock market are the US patents. 6,497,676 and 6,503,062. SUMMARY OF THE INVENTION The present invention in a primary embodiment performs an integrity test on the characteristics of the sleeve and the cartridge mold of the disposable cartridge. The methodology of the invention is applied to many pumping systems based on cartridges and liquid distribution and is particularly suitable for dialysis treatment, such as automated peritoneal dialysis. The stages of the integrity tests are performed almost exclusively before the solution bags, such as peritoneal dialysis solution bags are connected to the dialysis therapy machine, such as a peritoneal dialysis machine. That test is advantageous because integrity problems arise, the patient only has to discard the disposable cartridge and the associated tubing, not the solution. Also because the fluid is not connected to the machine to perform the test, there is no opportunity for the fluid due to a leak to be absorbed in the pneumatic system of the machine causing a potential malfunction. The dry tests of the present invention are performed with all lines of fluid plugged except the drain line, which is covered with a tip guard and / or membrane that allows air to escape but not the liquid. Because the lines remain covered, they are not connected to the solution bags. Consequently, the solution bags are not contaminated if the cartridge has a leak. The stages of. test are able to be performed with the lines covered for several reasons: In some stages, the tip protectors or covers, connected to all lines except the drain line are left in place because the cover and the flow paths they are tested with valves in the open position and not in the closed position. When the valves are open, all channels in the cartridge are in direct communication with both the pump chambers and the drain line, which has a tip guard that retains the bacteria that allows air to pass through it. The air from a failed test can then pass through the drain line from the cartridge, changing the pressure in the system in such a way that a leak can be detected. In other stages of the test, the tip protectors can be left in place because one part of the system is under pressure, while the other part is under vacuum. The air leaks from the positively pressurized stop of the cartridge goes to the evacuated part and can easily be detected as air escaping or leaking into the cartridge. In addition, because air flows more easily than water or solution through the leak, the air test is more expeditious and sensitive than the fluid-based test, increasing accuracy and repeatability and reducing test time. The present invention in another primary embodiment provides an apparatus and method for priming a medicinal fluid delivery system. The priming method and the apparatus are described herein for a peritoneal dialysis machine, however, the test can be applied to any fluid delivery system, which requires purging of the air for safety reasons or operational reasons. The method and apparatus operates with a system having a fluid container or fluid bag, at least one fluid pump and at least one line of tubing, such as a patient line extending from the fluid pump. In a first stage of the priming method, the valves surrounding the fluid pump are configured in such a way that the fluid flows by gravity or by means of the pump into the pump chamber and fills each pump chamber but it does not leave the camera. In a second stage, the valves are switched in such a way that the fluid in the supply bag can no longer fill the pumping chambers, and in such a way that the pumping chambers can be pressurized and thus pump the fluid from the pumping chamber downstream and partially up to the patient's line. The machine processor is configured to wait for a pressure drop in the pumping chamber when the pumping chamber expels fluid from it. If this pressure drop is not observed, the patient has probably forgotten to remove the clamp on the patient's line and an error message is generated. In one stage. Finally, the valves surrounding the pump open in such a way that the fluid in the container or bag can continue to flow and prime the patient's line until the fluid reaches the end of the patient's line, which is placed at the same height than the upper part of the fluid in the fluid container. As indicated beforeIf the patient's line is pinched during priming, the pressure in the pump chamber during the push stage will not fall to an expected level, producing an adequate alarm. In addition, the initial thrust of fluid through the proximal part of the patient's line, closer to the cartridge will in many cases exceed the resistance to fluid flow caused by the air trapped in that portion of the line, and allow the priming may take place after a proper manner. Another primary aspect of the present invention is an apparatus and method for determining the vertical position or HEIGHT ON the HEAD of one or more bags of solution as well as a drainage bag. The method and apparatus use atmospheric pressure to establish a zero position in relation to the therapy machine, such as an APD machine. The determination of the height of the bag can determine whether a solution bag in the appropriate position to achieve a pumped flow rate, if the solution bag is placed on a heating plate, if the relative position between two or more bags is the adequate, if the drainage bag is located in an appropriate position or if one or more of the bags is empty, etc. Therefore, it is an advantage of the present invention to provide an integrity test that consumes less time than previous practices. It is another advantage of the present invention that it provides an integrity test that is more effective in detecting leaks than previous practices. It is another advantage of the present invention to provide an integrity test that is more convenient for the patient if a leak is detected. It is another advantage of the present invention to provide an integrity test that minimizes the supplies that must be discarded if a leak is detected. It is another advantage of the present invention that it provides an integrity test that is immune to faults of other components of the machine, such as a line flow shutter. It is another advantage of the present invention to provide an integrity test that does not require a hot solution. It is yet another advantage of the present invention to provide an integrity test with which it is possible for a user to distinguish between a failure of the disposable equipment and a leak in the pneumatic system of the machine or the cycler.

Furthermore, it is an advantage of the present invention to eliminate false shots due to the cold solution used in the integrity tests. Furthermore, it is still an advantage of the present invention to provide a priming method and apparatus that automatically operates to destroy air pockets located initially in the priming line, which would otherwise tend to reduce or completely stop the priming. Yet another advantage of the present invention is to provide a method and apparatus that detects when the patient or operator has inadvertently left a clamp on the priming line, so that the therapy machine can generate an adequate alarm. Still another advantage of the present invention is the ability to determine the elevational location and the HEIGHT ON the HEAD of one or more solution or drainage bags. The additional features and advantages of the present invention are described in and will be apparent from the following detailed description of the invention and the figures. BRIEF DESCRIPTION OF THE FIGURES Figures 1 to 4 are opposite views of a cartridge showing different areas of the cartridge that are examined in their integrity during a known integrity test. Figure 5 is a plan view of a disposable equipment embodiment that operates with the integrity test of the present invention.

Figure 6 is a perspective view of one embodiment of a machine that can accept the disposable equipment cartridge shown in Figure 5. Figure 7 is a perspective view of the disposable equipment shown in Figure 5 in which the flexible membranes of the cartridge are separated to show the different internal components of the cartridge. Figure 8 is a portion of a cross-section taken along the line V1-1 -V111 in Figure 7. Figure 9 is a schematic view of a pneumatic operating system embodiment for the machine and the cartridge shown in figure 6. Figures 1 to 15 are elevational views of opposite sides of the cartridge shown in figure 5 illustrating the different components or areas of the cartridge that are examined in their entirety in the different stages of a test mode. of integrity of the present invention. Figure 16 is a schematic illustration of an alternative medical fluid machine employing mechanical positive pressure versus mechanical pressure drive. Figures 17 to 22 are schematic views illustrating an apparatus and method of the present invention for priming a medicinal fluid system.

Figures 23 and 24 are schematic views illustrating a method and apparatus of the present invention that evaluates the main heights of the solution and drainage bags. DETAILED DESCRIPTION OF THE INVENTION A primary aspect of the present invention is an improved system for the detection of leaks for any type of therapy with cartridge-based medicinal fluids that exerts positive or negative mechanical or pneumatic pressure on a disposable fluid cartridge. Another primary aspect of the present invention is an improved priming technique for a therapeutic machine for medicinal fluids, such as the automatic peritoneal dialysis system ("APD"). While APD is the preferred use of the present invention, any system of medicinal fluids based on cartridges or systems using a sterile disposable fluid cartridge may employ the apparatuses and methods of the present invention. Another primary aspect of the present invention is to provide an apparatus and a method for determining the HEIGHT ON the HEAD of the solution. Improved Cartridge-Based Test The following method is a "dry" method, which is more sensitive to leaks and other defects when compared to a fluid-based integrity test. The method also eliminates some problems associated with old tests, such as having to discard solution bags or potentially damaging the mechanical components of the machine after a leak.

Referring now to the figures and in particular to Figures 5 to 9, Figure 5 illustrates disposable equipment 50 that includes a disposable cartridge 1 00 as well as a tube kit. As shown in the exploded segment 52, the pipeline equipment includes a line a heater line 54, a drainage line 56, first supply lines 48, a day / primary bag line 60, second supply line 62, last fill line 64 and patient line 66. Each of these lines in one mode is used with the HomeChoice® machine. However, it should be appreciated that other lines associated with other dialysis systems or medicinal fluids may alternatively be used with the present invention. Automatic machines for peritoneal dialysis ("APD"), general dialysis machines or machines for medicinal fluids other than dialysis machines are collectively referred to herein as medicinal fluid machines 1 50, which is shown in Figure 6. more or fewer lines can be used without departing from the scope of the invention. Each of the lines 54 and 66 terminates with a first end on the cartridge 1 00 and with a second end on an organizer 42. During operation the machine 150 holds the organizer 42 initially at a height which allows a gravity priming for filling the fluid substantially at the end of at least some of the lines 54 and 66 without filling with fluid beyond the connectors located at the end of those lines. The priming is described in more detail below.

Figure 6 illustrates that the cartridge 1 00 and tubes 54 to 66 of the equipment 40 are vertically loaded in a mode in the machine 150 and held firmly in place between the door seal 152 and the diaphragm 154. The seal the door 152 is attached to the door 156, which opens when rotated and closed to removably maintain the cartridge 100 in place. The diaphragm 154 provides an interface between the valve and pump actuators, located within the machine 150 behind the diaphragm 154, and the valve and the receiver chambers of the pumped fluid located in the cartridge 1 00. FIG. 7 is a view in FIG. The perspective of the cartridge 1 00 shows that the cartridge 100 includes a housing 102, which is sealed on both sides by means of flexible membranes 1 04 and 106. The housing defines a plurality of pumping chambers P1 and P2, the valves V1 to V10 ( which are located on the opposite side of the housing 102 from the side shown in Figure 7), a plurality of flow paths F1 to F9 and a plurality of ports 1 08 that extend through an internal divider 1 1 0 that divides housing 1 02 and cartridge 1 00 in two separate flow distributors. Figure 8 illustrates a cross-section taken through the line V1-l1-V1-1 shown in Figure 7. The cross-section shows a membrane 1 06, a divider 1110 and a port 108 described above. Additionally, the walls of the external valve chamber 1 12 and the wall of the internal valve chamber 1 14 are illustrated, which cooperate to produce one of the valves V1 to V10 on one side of the cartridge divider 100. In addition, the wall of the valve the inner chamber 1 14 cooperates with a backrest 16 (which can also be a flexible membrane) to create several of the fluid paths F1 to F1 1 on the other side of the divider 1 10 of the cartridge 100. The flexible membrane 106 seals the external walls of the external chamber 1 12 and after the application of a force f the walls of the chamber 1 14 (to close a fluid connection between a first path F1 to F1 1 and a second one of those paths). After the release of the force f or the application of a vacuum or negative force to the membrane 106, the membrane 106 is removed from the inner wall 14, reestablishing communication between the fluid paths. Figure 9 illustrates a schematic view of a pneumatic control system 10 for a dialysis machine, such as a machine for peritoneal dialysis. Figure 9 is a schematic of the pneumatic control system employed in the HomeChoice® automatic peritoneal dialysis system and is useful in describing the operation of the present invention. However, it should be appreciated that the teachings of the present invention are not limited to the HomeChoice® machine or those machines having the same or similar components. Rather, the present invention describes a test and methodology that is applicable to many different medicinal fluid systems. In an adjustment portion of the integrity test of the present invention, the cartridge 100 is loaded in the dialysis machine 150. To do this, an air pump (not shown) is operated. That air pump communicates with various pneumatic components illustrated in Figure 9, including the emergency vent valve A5, the plug valve C6, and the actuators C0, C1, C2, C3, C4, D1, D2, D3, D4 and D5 for the fluid valves, which cause a shutter 158 (see also Figure 6) to retract to allow the disposable equipment 50 and the cartridge 100 to be loaded in the machine 150. Once the equipment 50 has been loaded, the emergency vent valve A5 is closed, such that a positive pressure bladder 129 can be inflated, which seals the cartridge 100 between the door 156 and the diaphragm 154, while the shutter 158 is held in an open position ( figure 6). The rest of the test is illustrated in Figures 10 to 14. Referring now to Figure 10, a first stage of the test examines the pump chambers P1 and P2 using a positive pressure and test valves V1 to V10 using negative pressure . In particular the coating of the cartridge 100 on the pump chambers P1 and P2 is pressurized using +5 psig (+0.35 kg / cm2) using the positive low pressure tank 220 and the valves A3 and B1 shown in figure 9. A vacuum of -5 psig (-0.35 kg / cm2) is sent in the laminate of cartridge 100 through fluid valves V1 to V10 using negative tank 214 and valves A0 to B4 shown in figure 1. The simultaneous pressure drop tests are conducted in the: (a) volume of air in the lower positive tank 220 and the pumping chambers P1 and P2; and (i) the volume of air in the negative tank 214 and the fluid valves V1 to V1 0. If the pressure drop in the positive pressure system exceeds for example 0.07 kg / cm2, an alarm is sent to show a error or damage code in a fluid valve. The tested areas of positive pressure for this first stage are shown in double stripes and the areas of negative pressure studied are shown in single stripes in Figure 10. It is important that the test stage one examines the cartridge 100 from the outside. This is the pressure applied to the outside of the coating on the pump chambers P 1 and P 2 and the negative pressure is applied to the outside of the coating on the valves V 1 to V 10. As described below, the remaining test steps apply positive pressure and negative pressure to the coating from inside the cartridge. The designation of the figures however is the same, in fact the areas of positive pressure tests (internal and external) are shown using double stripes. Negative pressure areas (internal and external) are shown using a simple line. Ports 1 08 tested at each stage are obscured and labeled either as "positive pressure test" or "negative pressure test". Referring now to Figure 11, a second stage of the test of the present invention examines the pump chambers P1 and P2, certain fluid paths and certain valves use positive pressure and negative pressure. The second stage begins by evacuating the negative tank 214 to -5 psig (0.35 kg / cm2) and opening the valve B4 to fill the pump chamber P2 in the cartridge with air through the open fluid valve V7. Then the positive low pressure tank 220 is pressurized to +5 psig (0.35 kg / cm2) and the A3 valve opens to empty a pumping chamber P1 through the fluid valve V1 0. The fluid valves V7 and V1 0 then close. The shut-off valve C6 is de-energized in such a way that the shutter 158 closes, throttling / sealing all fluid lines 54 to 66 that exit the cartridge 100. The valves A3 and B4 then close. The actuator valve B1 opens with open fluid valves V4, V6 and / 7 to pressurize the air in the pump chamber P2 of the cartridge and to examine the fluid paths downstream of V4, V6 and V7 for the leakage through of the obturator 158 and / or through the fluid channels within the cartridge. The actuator valve AO is then opened with the fluid valves V1, V2 and V9 open to create a vacuum in the pumping chamber P1 of the cartridge and to examine the fluid path downstream of V1, V2 and V9 to look for leaks through of a shutter 158 and / or through the fluid channels within the cartridge. Then a first group of simultaneous pressure drop / rise tests are conducted in the positive pressure tank 222 and the negative pressure tank 214. The difference in pressure in the positive pressure tank 220 and negative pressure 214 is recorded as well as the final pressure in positive pressure tank 220 and in negative pressure tank 214. Valve V3 opens and a second set of simultaneous pressure drop / rise tests is performed in a low positive pressure tank 220 and in a tank of negative pressure 214 as the contents of the pump chamber P2 flows freely in the pump chamber P1 through the open valves V1 and V4. If the sum of differences in pressure from the first pressure drop test equipment exceeds for example two psig (0.14 kg / cm2) and the sum of the difference in pressure of the second test group in less than one psig (0.07 kg) / cm2), an alarm is issued for an interference leakage error.

The positive pressure examined areas for the second stage are shown in double stripes and with the ports 108 marked as such and the negative pressure test areas are shown in a simple scratch and with the ports 108 labeled in that way in Figure 1 1 . Referring now to Figure 12, a third stage of the test, examines the pump chambers P1 and P2, certain fluid paths and certain valves that use positive pressure and negative pressure. The third stage starts by evacuating the negative pressure tank 214 to -5 psig (3.5 kg / cm2) and opening the valve B4 to fill the filling pump chamber P2 in the cartridge with air through the valve V7. The low positive pressure tank 220 is then pressurized to +5 psig (3.5 kg / cm2) and the valve A3 is opened to empty the pump chamber P1 through the open fluid valve V10. The valves V7 and V1 0 then close. Seal valve C6 is de-energized in such a way that shutter 158 closes by throttling / sealing all lines of fluid exiting cartridge 100. Valves A3 and B4 then close. The actuator valve B1 opens with open fluid valves V3, V4 and V6 to pressurize the air in the pump chamber P2 of the cartridge and to examine the fluid paths downstream of V3, V4 and V6 for leaks through the shutter 58 and / or through the fluid channels within the cartridge 100. The actuator valve A0 is then opened with the fluid valves V2, V9 and V10 open to create a vacuum in the pump chamber P1 of the cartridge and to examine the fluid path downstream of V2, V9 and V1 0 to search for leaks through a shutter 158 and / or through the fluid channels within the cartridge 100. Next a first group of simultaneous pressure drop / rise tests is performed. conduct in the positive pressure tank 222 and the negative pressure tank 214. The difference in pressure in the positive pressure tank 220 and negative pressure 214 is recorded as well as the final pressure in the positive pressure tank 220 and in the negative pressure tank 214. The valve V1 is opened and a second set of simultaneous pressure drop / rise tests is performed in a low positive pressure tank 220 and in a negative pressure tank 214 as the content of the pump chamber P2 flows freely in the pump chamber P1 through the open valves V1 and V3. If the sum of the differences in pressure from the first pressure drop test equipment exceeds, for example, 2 psig (0.14 kg / cm2) and the sum of the difference in pressure of the second test group in less than one psig (0.07 kg) / cm2), an alarm is issued for an interference leakage error. The positive pressure examined areas for the third stage are shown in double stripes and with the ports 108 marked as well and the negative pressure test areas are shown in a simple scratch and with ports 1 08 labeled in that way in figure 12 Referring now to Figure 13, a fourth stage of the test, examines pumping chambers P1 and P2, certain fluid trajectories and certain valves using positive pressure and negative pressure. The third stage starts by evacuating the negative pressure tank 214 at -5 psig (3.5 kg / cm2) and opening the valve B4 to fill the filling pumping chamber P2 in the cartridge 100 with air through the valve V7. The low positive pressure tank 220 is then pressurized to +5 psig (3.5 kg / em2) and the valve A3 is opened to empty the pump chamber P1 through the open fluid valve V10. The valves V7 and V10 then close. The plug valve C6 is de-energized in such a way that the shutter 158 closes by throttling / sealing all fluid lines 54 through 66 that exit cartridge 1 00. Valves A3 and B4 then close. The actuator valve B1 opens with the fluid valve V5 open to pressurize the air in the pump chamber P2 of the cartridge and to examine the fluid paths downstream of V5 for leaks through the shutter 158 and / or through the Fluid channels inside the cartridge 100. The actuator valve A0 is then opened with the fluid valves V1, V2 and V9 open to create a vacuum in the pump chamber P1 of the cartridge and to examine the fluid path downstream of V1, V2, V9 and V10 to search for leaks through a shutter 158 and / or through the fluid channels within the cartridge. Then a first group of simultaneous pressure drop / rise tests are conducted in the positive pressure tank 222 and the negative pressure tank 214. The difference in pressure in the positive pressure tank 220 and negative pressure 214 is recorded as well as the final pressure in positive pressure tank 220 and in negative pressure tank 214. Valve V3 opens and a second set of simultaneous pressure drop / rise tests is performed in a low positive pressure tank 220 and in a tank of negative pressure 214 as the contents of the pump chamber P2 flows freely in the pump chamber P1 through the open valves V1 and V3. If the sum of differences in pressure from the first pressure drop test equipment exceeds, for example, 1.5 psig (0.105 kg / cm2) and the sum of the difference in pressure of the second test group at less than 0.75 psig ( 0.05 kg / cm2), an alarm is issued for an interference leakage error. The positive pressure examined areas for the third stage are shown in double stripes and with ports 1 08 marked as well and the negative pressure test areas are shown in a simple scratch and with ports 1 08 labeled in that way in the figure 1 3. Referring now to Figure 14, a fifth stage of the test, examines pumping chambers P1 and P2, certain fluid trajectories and certain valves that use positive pressure and negative pressure. The third stage starts by evacuating the negative pressure tank 214 to -5 psig (3.5 kg / cm2) and opening the valve B4 to fill the filling pumping chamber P2 in the cartridge 1 00 with air through the valve V7. The low positive pressure tank 220 is then pressurized to +5 psig (3.5 kg / cm2) and the A3 valve opens to empty the pump chamber P1 through the open fluid valve V8. Valves V7 and V1 0 are closed. The shut-off valve C6 is de-energized in such a way that the shutter 158 closes by throttling / sealing all fluid lines 54 to 66 that exit the cartridge 100. The valves A3 and B4 then close. The actuator valve B 1 is opened with the fluid valve V3, V4, V6 and V7 open to pressurize the air in the pump chamber P2 of the cartridge and to examine the fluid paths downstream of V3, V4, V6 and V7 for leakage through the shutter 158 and / or through the fluid channels within the cartridge 100. The actuator valve AO is then opened with the fluid valves V8 open to create a vacuum in the pump chamber P 1 of the cartridge and for examining the fluid path downstream of V8 to look for leaks through a shutter 158 and / or through the fluid channels within the cartridge. Then a first group of simultaneous pressure drop / rise tests are conducted in the positive pressure tank 222 and the negative pressure tank 214. The difference in pressure in the positive pressure tank 220 and negative pressure 214 is recorded as well as the final pressure in positive pressure tank 220 and in negative pressure tank 214. Valve V1 opens and a second group of simultaneous pressure drop / rise tests is performed in a low positive pressure tank 220 and in a tank of negative pressure 214 as the contents of the pump chamber P2 flows freely in the pump chamber P1 through the open valves V1 and V3. If the sum of differences in pressure from the first pressure drop test equipment exceeds, for example, 1.5 psig (0.105 kg / cm2) and the sum of the difference in pressure of the second test group at less than 0.75 psig ( 0.05 kg / cm2), an alarm is issued for an interference leakage error. The positive pressure examined areas for the third stage are shown in double stripes and with ports 1 08 thus marked and the negative pressure test areas are shown in a simple scratch and with ports 108 marked in that way in Figure 14 In each of the test stages two to five of the figures 1 to 14 described above, the pumping chamber P2 is filled with air and the pumping chamber P1 is evacuated before the pressure drop tests are carried out. / increase of vacuum. These tests are improved when the P2 chamber is pressurized above atmospheric pressure contrary to just maintaining the atmospheric pressure in the chamber. For one reason, keeping the P2 camera at a positive pressure compensates for the slight understanding of the air in the chamber when the test stages begin. To pressurize the chamber P2, the air can be pushed from the chamber P1 to P2 with the shutter 158 closed. When P2 is pressurized, shutter 158 opens, allowing chamber P1 to be evacuated. The pressurized chamber P2 must show a reduced pressure drop in hands that a leak is detected in one of the examined trajectories. Referring now to Figure 15, a sixth cap of the present invention tests the pump chambers P1 and P2, certain fluid paths and certain valve ports 108 using positive pressure. To begin the sixth stage, a vacuum of -5 psig (3.5 kg / cm2) is drawn into the cartridge cover over two pumping chambers P1 and P2 with all the fluid valves except the de-energized (closed) V7 and V10 valves. such that the pumping chambers P1 and P2 are filled with air. Valves V7 and V1 0 are closed and the coating on pumping chambers P1 and P2 of cartridge 1 00 is pressurized to +5 pslg (3.5 kg / cm2) using a low positive pressure tank 220 and valves A3 and B1. A first pressure drop test is then conducted in the pumping chambers P1 and P2, the fancy fluid paths F6, F7, F8 and F9 and the obscured fluid ports 108 thus marked inside the cartridge 1 00 by means of monitoring of the pressure in the low positive pressure tank 220. If the difference in the positive pressure tank 220 exceeds, for example a psig, an alarm is measured showing an error or leak code in the fluid valve. Seal valve C6 is de-energized such that shutter 158 closes, throttling / sealing all fluid lines 54 to 66 that exit cartridge 100. Valves A3 and B4 then close. All valves V1 to V1 0 except V5 and V8 are opened and a second pressure drop test is performed by monitoring the pressure in the positive pressure tank 220. If the difference in pressure in a positive pressure tank 220 exceeds by For example, a psig (0.07 kg / cm2) should be repeated the sixth series of tests. If the difference in pressure in. the low positive pressure tank 220 exceeds for example a psig (0.07 kg / cm2) a second time, an alarm is issued indicating that the shutter failed. Finally the shutter opens and a third pressure drop test is performed by monitoring the pressure in the low positive pressure tank 220. Stage six verifies that tests one and two have not failed if the pressure difference exceeds, for example, 1 psig (0.07 kg / cm2). The positive pressure examined areas for the sixth stage are shown in double stripes and with the ports 108 marked in that manner in Figure 15. The six previous steps complete a dry integrity test mode of the present invention. Looking at the result of steps 1 to 4 of the tests according to the prior art in Figures 1 to 4, it should be noted that stage 1, shown in Figure 10 of the dry disposable integrity test of the present invention, examines the equivalent components of all four stages of the original dry integrity test. It is important that test stages two through six test the cartridge from the inside. This is positive pressure is applied inside the cartridge to the inside of the cartridge coating and negative pressure is applied inside the cartridge to the cartridge coating. The positive and negative pressures applied inside the cartridge to the inside of the cartridge cover are created by initially applying pressure (positive or negative) to the exterior of the cartridge and changing the valves to create the desired pressure distribution within the cartridge as described above. The first five of the stages (figures 1 0 to 14) can be made with the tip protectors placed on lines 54 and 66 and with the clamps closed on all lines except the drainage line 56. The tip protectors, shown figuratively as caps 1 18 in the respective ports of the cartridge 100, actually lie at the ends of the tubes 54, 58, 60, 62, 64 and 66. The drain line has a tip guard that retains the bacteria which passes the air from the atmosphere that leaks through the membranes 104 and 1 06 (figures 7 and 8) or from the housing 1 02, reducing the pressure in the system such that a leak can be detected. The tip protectors are removed when the solution bags are connected to the tubes prior to test stage six in the series of six test stages. As seen in the previous steps 2 to 4 of figures 2 to 4, all tip guards have to be removed from those test steps. In prior art, when a cartridge fails during any of the tests illustrated in Figures 2 to 4, non-sterile air is introduced into the solution bags, causing the solution bags and the cartridge to be discarded. Test stages two to five of the present invention (Figures 1 to 14, respectively), using air within the cartridge, the same areas of the cartridge as used in the wet leakage test of the prior art. Because steps (i) to (v) of the wet leakage test of the prior art require fluid, solution bags must be used to obtain that fluid. The present invention eliminates that need. The test stage one of the present invention is capable of leaving the tip guards connected to all lines except the drain line because the valves are examined in the open position and not in the closed position. When valves V1 to V10 are open, all the fluid channels F1 to F1 1 in the cartridge 1 0 are in direct communication with the pump chambers P1 and P2 and the drain line. The drainage line has a bacterial retention tip guard that allows the passage of air, for example it has a hydrophobic membrane. The failed test air can then pass through the drainage line of the cartridge 100, changing the pressure in the system such that a leak can be detected. Test stages two to five of the disposable integrity test of the present invention are capable of leaving the tip guards in place because one part of the system is pressurized while the other is evacuated. The air that escapes from the positive pressure part of the cartridge 1 0 to the evacuated part is easily detectable since the air escaping or leaking to the cartridge 1 00. Due to the air flow it is thus easy that what the air does. Water or solution by means of a leak, the air test is faster and more sensitive than a fluid-based test, increasing accuracy and repeatability and decreasing test time. Test stages two through five of the present invention include a redundant pressure drop test that verifies the results of the first pressure drop test. All four test stages two to five are looking for flow leaks from a pressurized section of the cartridge 1 00 to an evacuated section of the cartridge 100. If a leak arises between the two sections of the cartridge, the pressure in the two sections should tend to balance when the air flows from the high pressure section to the evacuated section. The redundant test opens the valves between positive and negative sections at the end of the first pressure drop test to verify that a significant pressure change occurs if there are no leaks or a minimum pressure change if a change exists. A failure in shutter 158 to properly close pipe lines 54 to 66 does not materially affect the results of test steps two to zinc because the tip guards are in place and would otherwise seal all lines that are They are examining. Additionally, users / patients are instructed to close the line clamps on all lines except the drain line when the equipment 50 is placed on the machine 1 50. Stage six, which examines the cartridge valves V1 to V10 and the shutter 158 can be driven wet or dry since the solution bags have been connected. The dry test would have to be based on pressure, while the fluid test could be based on either pressure or volume. The user may place a clamp or clamp on the drainage line of the disposable equipment when instructed to do so after a failure in the integrity test by using the method of the present invention and re-perform the disposable integrity test. If the tests do not show a failure a second time (for many of the fault models), the disposable equipment can be considered responsible for the figure and not the machine 150, for example the pneumatic system of the machine and / or the system interface and / or cartridge / machine. This feature is useful when a patient seeks assistance to solve the problem. The determination that the machine 150 is working properly and that the cartridge 1 00 is causing the failure prevents the patient from being unnecessarily from the machine after an integrity failure due to the uncertainty of whether the cartridge 1 00 or the machine 150 is responsible for the failure of the test. On the contrary, the test shows a failure for a second time, the machine 1 50 and / or the cartridge / machine interface can be considered responsible for the leak. While the cartridge 100 is illustrated with pumping chambers P1 and P2, the valve chambers V1 to V1 0, the associated ports 108, and the fluid paths F1 to F1 1, it should be appreciated that the method of the invention is equally applicable to cartridges and drive systems that have different pump geometries and valves than those shown, as well as additional features such as heaters, pressure sensors, temperature sensors, concentration sensors, blood detectors, filters, air separators, bubble detectors, etc. The cartridges can be. Rigid with a single coating side, can be rigid with a dual coating side, have double laminations forming fluid paths, have a rigid portion connected to the flexible portion, etc. The cartridges are used in any application of medicinal fluid supply, such as peritoneal dialysis, hemodialysis, hemofiltration, hemodiafiltration, continued renal replacement therapy, drug supply, plasma pheresis, etc. and any combination of these. Figure 16 shows an alternative embodiment of the present invention by means of the system 200, in which the pneumatic source of positive pressure used before is replaced by means of a mechanical actuator 202 that pushes a flexible membrane film 203. The film 203 joins a cartridge 210 with a coating 204 on one of its sides. The system 200 uses a vacuum to force the membrane 203 to follow the head of a piston 206 when the head 206 retracts from or moves toward the cartridge 210. While no source of positive pressure is provided, the air can be withdrawn to the pump chamber 208, while the fluid valve 212 is closed and the actuator 202 and the head 206 are moved forward to generate an internal pressure that is used to perform the disposable integrity tests described herein. A pressure sensor 214 is performed in a mode to perform the pressure drop tests. The position of the actuator 202 and the head 206 can also be used to perform a leakage test by applying a constant force. The actuator and head should remain stationary when a constant force is applied if there are no leaks present. The forward movement would indicate that there is a leak in the system being tested. Appendix A shows data from stage one of the integrity test of the present invention. Appendix B also shows the integrity test data of the present invention. In Appendix B the data in a larger font size and in bold letters show when defects were detected. It is worth mentioning that for fifty different tested cartridges and that were known to be defective, the fifty defects were detected. When the drain line was closed after the software instructed the operator to do so, forty-seven of the fifty tests no longer failed indicating that the leak is in the cartridge and not in the therapeutic machine. The other three of the obstruction tests were inconclusive. Those three are indicated in bold italic letters. It is also worth noting that a cartridge appears to have two defects and is also indicated in bold italics. For the test ten defects were created in the lining of the pump chamber and forty defects were created in the valve cover. All pumping chamber tests were performed with positive pressure and all valve coating tests were performed with negative pressure. The defects were perforations and cuts made by a hot needle with an outside diameter of 0.035 inches(0.89 mm) or an exact blade with a stop placed to create constant 0.125 inch (3.2 mm) slots. Appendix C shows data from stage two of the integrity test of the present invention. The positive pressure represents pressures inside the pumping chamber P2, measured by the pressure sensors that monitor the negative tank 214 (figure 9). The cartridges predisposed with a number of defects were tested as well as some cartridges with known defects. Some of the defects were not detected by stage two of the test. Test stages three, four and five revealed however the defects that stage two does not. Improved Method and Priming Apparatus Considering the method and apparatus of the present invention, the method and the apparatus are advantageous in many aspects. First, the method uses the pumps of the medical fluid machine 150 shown above in FIG. 6 to prime the priming fluid for an initial portion of the priming to dislodge air bubbles that are typically entrapped, for example, in the patient line. , near the cartridge 100. Second, the method uses software contained within the machine controller 150 which expects to see a particular pressure drop when the pump (or pumps) of the medicinal fluid pushes the initial priming fluid. If the expected pressure drop is not observed, the machine 150 assumes that there is a clamp on the patient's line, responds accordingly and sends an appropriate message or error code. Referring now to Figure 17, an initial scheme of an apparatus 250 for performing the priming method of the present invention is shown. The apparatus includes a supply bag 252 filled with a - fluid volume 254. A line is provided from solution bag 252 to pumps P1 and P2. In most cases the line is the heater bag line 54 shown in Figures 5 or 17, which enters the cartridge 1 00 which houses the pumping chambers P1 and P2. Valves 25.6 and 258 selectively allow fluid 254 to pass through line 54 to pump chambers P1 and P2, respectively. A priming line is provided from the pump chambers P1 to P2 to the distal end of the line, which is provided with a ventilated distal end connector 260. Usually the barley line is the patient line shown as line 66 in the Figure 5 and 1 7. It should be appreciated however the priming line may be a priming line may be a different line than the patient line. In addition, the primed line is the patient line shown as line 66 in FIGS. 5 and 17. It should be appreciated, however, that the priming line may be a line different from the patient's line. In addition, the priming apparatus 250 and the associated method is applicable to systems that multiple multiple lines sequentially or simultaneously. The connector 260 as illustrated is placed in an organizer 42 described above in connection with Figure 5. The placement of the connector 260 is determined such that the priming stops at a desired point at the start of or inside the connector 260 That level as shown by line 262 is the same level as fluid height 254 in container 252. Valves 266 to 268 are provided between pumps P1 and P2 and connector 260 to selectively allow fluid to enter. the patient line or the priming line 66. The first stage of the priming method shown in Fig. 17 is to close the valves 266 and 268 (black) and open the valves 256 and 258 (white). That valve arrangement allows the fluid 254 to be fed by gravity or is extracted by the pumps P1 and P2 1 .5 psig (0.105 kg / cm2) shown in figure 17 it symbolizes the suction that is being applied to the flexible pump film as the fluid is drawn to the pump chamber) from the container 252 and fills the pump chambers P1 and P2. Because valves 266 and 268 are closed, no fluid enters the priming line 66. Figure 18 illustrates a second step of the priming method of the present invention. In Figure 18, the valves 256 and 258 are closed (black), so that no additional fluid can flow through the line of the heater bag 54 from the container 252 to the pump chambers P 1 and P 2 . Then a pressure of 1.0 psig (0.07 kg / cm2) is applied to the flexible pump film, pressing the film against the fluid in the pump chambers P1 and P2. The valves 266 and 268 then open (white) such that there is a fluid communication between the pumping chambers P1 and P2, the priming line or patient 66 and the connector 260.

Figure 1 9 illustrates that after pressurizing pumping chambers P1 and P2, fluid flows from those chambers through an initial portion of the patient or priming line 66. The pressure inside pumping chambers P1 and P2 falls accordingly to approximately 0.1 psig (0.007 kg / cm2) as the fluid moves from the pump chambers and expands the volume of the air that pushes against the pump film. The fluid pumped from the chambers P1 and P2 is not intended to extend to the connector 260, rather the pumped fluid is intended to flow through any trapped air at the proximal end of the patient line 66, such that that air is not an impediment to priming. Therefore the volume of fluid withdrawn to the pump chambers P1 and P2 must be less than the volume within the patient line 66 that extends from the cartridge 1 00 to the connector 260. The volume of the liquid that fills the line of the patient 66 through pumping the chambers P1 and P2 however pushes some of the air through the ventilated connector 260, leaving the line partially filled with solution and partially filled with air, in which air is collected at the distal end and the solution resides at the proximal end of line 66. This destruction method works regardless of how many extensions are added to the patient line 66. The previous priming sequences had different results depending on whether a standard length patient line was used. or non-standard. The present method is independent of the length of the patient's line and can be used with a heating bag containing only 1000 ml of solution as shown in table 1. Average barley height above the table Warming bag Warming bag Warming bag with a volume of with a volume of with a volume 1000 ml 6000 ml of 1000 ml Equipment without line of 7.17 7.8 6.28 extension for patient Equipment with 1 line of 6.8 7.95 6.34 extension for patient Equipment with 2 line of 6.5 - 7.88 6.23 extension for patient Standard deviation of the height above the table barley Heating bag Warming bag Warming bag with a volume of 1000 ml with a volume of 6000 ml 1000 ml Equipment without line of 0.52 0.16 0.27 extension for patient Equipment with 1 line of 1.35 0.16 0.1 1 extension for patient Equipment with 2 line of 0.5 0.1 3 0.23 extension for patient Table 1: Priming height of the patient line Figures 20 to 21 illustrate the final stage in the priming method associated with the apparatus 250. Here the inlet valves 256 and 258 open, while the outlet valves 266 and 268 are left open. In Figure 20 any fluid in pumping chambers P1 and P2 not pumped in Figure 19 is allowed to flow by gravity from those pump chambers to the patient line 66. Additionally fluid 254 is allowed to flow by gravity from the container 252 to complete the priming of the patient line. In Figure 20, the pressure in the chambers P1 and P2 can drop to about zero psig since any remaining pressure of the pumping in Figure 19 is dissipated. Figure 21 shows that the patient or priming line 66 is fully primed, with the level of fluid 254 reaching the elevational height 262 of the remaining fluid 254 in the bag 252. The fluid level within the pump chambers P1 and P2 will also reach some equilibrium that may be a slight positive pressure inside those chambers. This is the pressure in the pump chamber will equalize with the upper pressure of the patient line 66 and will fill the bag 252. If the patient's line 66 is inadvertently clogged during priming, the pressure in the pump chambers P1 and P2 in the stage illustrated by figure 19 does not fall below an expected level, for example of the one psig (0.07 kg / cm2) shown in figure 1 8 at 0.1 psig (0.007 kg / cm2) shown in figure 19 The pressure on the other hand remains at a higher level such as 0.5 psig (0.035 kg / cm2). The controller within the machine 150 records the discrepancy and indicates the patient by means of a visual message, auditory or audiovisual to unlock the patient line or priming 66. Figure 22 illustrates another advantage of the priming method of the present invention. A mixture of air and fluid may sometimes appear in the proximal part of the patient's line 66, near the cartridge 1 00, at the start of priming. The mixture is usually close to the cartridge 100 due to fluid that may have entered the line due to procedural mistakes during the placement procedure. For example, the patient may improperly connect the solution bag and open the clamps when the equipment is loaded. The mixture of air and fluid 254 can sometimes encourage and sometimes prevent proper priming. The pressurized assistance that begins in Figure 1 8 and ends in Figure 1 9 of the patient line 66 will typically solve or overcome the problems caused by the air / fluid mixture, allowing for adequate priming. Figure 16 described above shows an alternative embodiment of the priming method of the present invention, in which the system 200 replaces the pneumatic pumps P1 and P2 in Figure 17 to 21. The positive pressure pneumatic source used in Fig. 1 9 is replaced by a mechanical actuator 202, which pushes a flexible membrane film 203, which in turn attaches to the cartridge 210 having a coating 204 on one side thereof. The system 200 uses vacuum to form the membrane 203 to follow the head of the piston 206. When the head 206 retracts and moves toward the cartridge 21 0, withdrawing fluid in the pump chamber 208 when the fluid valve 212 find open. The actuator 202 and the head 206 move forward when another fluid valve (not shown) opens, pushing the fluid down the patient line. A pressure sensor 214 detects a pressure increase if the patient line is obstructed. The position of the actuator 202 and the head 206 can be used to determine when the valve open 212 such that gravity can complete the priming of the patient's line. Appendix D shows data of the priming method of the present invention. Additionally, the data in Appendix E is obtained from a software program that opened valves 256 and 258 when the pressure in pumping chambers P1 and P2 dropped below 0.2 psig (0.014 kg / cm2), pressure was recorded and a message stating "Time out before PosP reached 0.20 psig (0.014 kg / cm2) was stored. A number of normal primings were performed as well as a number of primings in which the patient's line was obstructed near the patient's connector in the distal end of the line Determining the Height of the Upper Head of the Solution Bag Dialysis, such as peritoneal dialysis or hemodialysis and other renal therapies such as hemofiltration or hemodiafiltration can be performed using bags of multiple solutions, such as such as dialysis bags, lactate bags and / or dextrose bags, in which case, it is advantageous to determine that the required solution bags are: (i) present and (ii) local They are raised at a suitable vertical height to allow the particular therapy to be performed, for example an automated peritoneal dialysis performed by a machine. These determinations should be made at the start of therapy, for example during priming and integrity testing of the cartridge, so that the machine can alert the patient to any problems before the treatment starts and / or before the patient go to sleep Referring now to Figures 23 and 24, a system 300 illustrates a modality for determining the upper height of the solution bag. The system 300 of Figure 23 includes solution pockets 302 and 304 which are fluidly connected to pumping chambers 306 and 308 via fluid lines 310 and 312, respectively. Pumping chambers 306 and 308 house flexible diaphragms 314 and 316 respectively. Dialysate or therapy fluid can flow from pump chambers 306 and 308 when fluid valves 318 and 320 are opened, through fluid path 322 to drain bag 324. System 300 includes valves 326 and 328 connected by fluid to chamber 306 and valves 330 and 332 fluidly connected to chamber 308. Air / vacuum chambers 338 and 340 are placed between valves 326 and 328 and 330 and 332 respectively. The differential pressure sensors 334 and 336 register the differential pressure within the chambers 338 and 340 respectively. It should be appreciated that if the valves 326, 328, 330 and 332 are opened, while pumping chambers 306 and 308 are empty, differential pressure sensor 334 (placed between valves 326 and 328) and differential pressure sensor 336 (placed between valves 330 and 332) and are at zero because the pressures in air / vacuum chambers 338 and 349 are equal to atmospheric pressure.

As seen in Figure 24, when valves 318, 320, 328 and 332 are closed and fluid valves 326, 330, 342 and 344 are opened, fluid from solution pockets 302 and 302 flows vertically downward from the fluid path 310 and 312, respectively, in the pump chambers 306 and 308. The respective flexible diaphragms 314 and 316 move as the fluid flows into the pump chambers 306 and 308, causing an increase in air pressure. trapped in the air / vacuum chambers 338 and 340. The fluid flows to the chambers 306 and 308 through the open valves 342 and 344, until the pressure in the respective air / vacuum chambers 338 and 340, as measured by pressure sensors 334 and 336, it is equal to the pressure exerted by the solution (approximately water for density purposes) on columns that are equal in height at the vertical distances Y1 and Y2. If the pressure equivalent to that exerted by the columns of the solution of the heights Y1 and Y2 is within a predetermined operating parameter for the therapy system with medicinal fluids 300 (for example an APD system), the therapy is allowed to continue If an adequate alarm is not issued informing the patient or operator that one or more solution bags 302 or 304 are placed outside the operating parameters of the system 300. A pressure difference caused by the differences in the vertical positions (upper heights of pressure) of the solution bags 302 and 304 also have to be within the limits for the system 300 to operate within the specification in one embodiment. An inlet side of a pump subjected to a negative upper height results in less fluid being pumped by each stroke of the chambers 306 and 308, compared to the blows made when, a positive upper height pressure is observed at the inlet of a pump .. Therefore when equal volumes of different solutions are pumped by the chambers 306 and 34308 and mixed at a desired ratio, for example 1: 1, it is advantageous that the vertical positions and the upper heights of the pressure of the two solutions so that it is the same or substantially the same. The previous description of the system 300 in Figures 23 and 24 illustrates how the sensors 334 and 336 can be zeroed and then used to test the height of the solution bag in the context of a filling sequence, ie the pumping 306 and 308 moving from empty to full. It should be appreciated that conversely, the sensors 334 and 336 can be zeroed and then used to examine the height of the drainage pockets in the context of a draining sequence, that is the pumping chambers 306 and 308 that move fully or partially filled to empty. In the drainage test, pumping chambers 306 and 308 are first filled with a fluid from solution pockets 302 and 304, respectively, upon opening valves 342 and 344, such that the therapeutic fluid flows through them. Fluid trajectories 31 0 and 312, respectively and towards the pumping chambers 306 and 308 as shown in Fig. 24. The valves 326, 328, 330 and 332, then open allowing the pressure in the air / vacuum chambers 334 and 336 are zeroed with respect to atmospheric pressure and allow the differential pressure sensor readings of the sensors 334 and 336 to be reactivated to zero. Valves 342, 344, 328 and 332 then close and valves 318, 320, 26 and 330 open. The fluid then flows from the pumping chambers 306 or 308, through a fluid path 322, the drainage bag 324. The diaphragms 314 and 31 6 within the pumping chambers 306 and 308 move accordingly, creating voids. respectively within the air / vacuum chambers 338 and 340, measured by means of pressure sensors 334 and 336, respectively, is equal to a solution column (negative pressure upper height) of the height Y3 shown in figure 23. The drainage test ensures that the drainage bag / drainage line discharge is located below pumping chambers 306 and 308, in such a way that there is no back flow due to gravity. The drainage test also ensures that the drain is not located too far below the pumps and valves, where the location causes an adverse effect on the operation of the valves. If the pressure equivalent to a solution column of height Y3 is within a predetermined operating parameter for the medical fluid therapeutic system 300, the therapy is allowed to continue. If not a suitable alarm is issued informing the patient or operator that drainage bag 324 has been placed outside the operating parameters of system 300. It should be understood that several changes and modifications to the currently preferred embodiments described herein will be apparent to the experts. in the technique. These changes and modifications can be made without departing from the spirit and scope of the present invention and without diminishing its intended advantages. It is intended that these changes and modifications be covered by the appended claims.

Test procedure Valve open 0-9 Valve open O SP to move the occluder Start pump A Open valve C Pressure control in + T to 7.1 psig Load set of occurrences Close valve P to seal the disposable Close ociusor Open valve D to pressurize + P around 5 psig Close valve Ó Open valve B to evacuate -P around 5 psig Close valve B Pressure register in + P and -P Open valve O to open the occluder Wait 30 seconds Pressure register in + P and - P Alarm if + P decreases below X Alarm if -P increases more than Y Test procedure Valve open VA1 to VA10 Valve open A5 & C6 to retract the occluder Start pump 84 Open valve C5 Bladder control height 128 to 7.1 psig Load the set of occurrences Close valve A5 to seal the disposable Close C6 to close the occluder Open valve A6 to pressurize + P around 5 psig Close valve A6 Abnr valve DO to evacuate tank Neg 214 around -5 psig Close valve DO Low pressure register 220 and 214 Neg Open valve C6 to open the occluder wait 30 seconds Low pressure register 220 and neg 214 Alarm if pos 220 descends below X Alarm if neg 214 is higher than Y Note: 1. Set of numbers that define a specific defect in the disposable system is commonly referred to as a set. Defect 0 is not defect. 2. The low pressures pos 220 and neg 214 are both recorded for each test. Tests announced in green should not be indicated as a defect. Tests not indicated should indicate a leak 3. All times are in seconds and all pressures are in psig 4 Test procedure is listed twice. One contains CRT instructions used to run the test. The second relates the pneumatic scheme.

Appendix B 1 of 4 Bfui D No, • f 2 .3 4 § íj 7 S d 10 11 12 Tsgmpo PF_ p PssP ftap Pß $ P F? $ P PosF PisSP P§sP PosP Posf Posp PosP 0 53 S S segúreles s, «S 3,67 S > S2 S, fS §5 5, $ 5.3 $ s, sa ..e? & SLIDES 5,49 §, 30 ÍU »5.53 S, fd 4M 5 > > ys s.28 s, m §.t7 1 2.8J .S1 .51 2 ® 2.28 3 ZM M 3 3 3.3 S.SZ S..Í - MB 2.S 3 * 1 ft7 0.34 2. € 6 9.58 2.1 & 1.52 0.74 5.SS 5.97 ß.W £ 2. 2.3 í O O tií.32 &r £ 0.22 ÍJ31 1.46 0.29 S S 5.m & .0S? S?: < ? m * 0 5 i? 0.03 144 124 Q? 6 5 ^ ? t? 0.04 1.35 1.3 »O.ftT 0 131 0.00 1M I S 0.03 Ú s, a Fall of 5 »2 © 2 44 d, 31 §.S? 421 SM Z 4.74 pesten S.32 - «. O? -ac «? tíeinpo ffe.r flsgÉ * t * > gP Nßgj * MégP ífea P H P ttegP íidgP tt & gp WCffP McpP Passed 0 -3.9 -3.78 -3B7 -t.M -a.?r -? J91 -3 -1,83 -a to -3JSE -2? -2.57 seconds 0 -3.04 -3 4 -3. $ -3.9 -3 S -3.8 í -3.91 -1Í? -3.β -3.89 -2 * 5 ^ 2.6? í «3.S > 4 -3ts * 3.df -f.§2 -3 ß -3.S2 -3 Í -1.3 * SM * 3.8Í -1.6-2 -t.ifi $ -3, f4 -3.a? - $, 92 -3.92 -3.88 «3JJ2 - 8Í -101 -S.S3- -3.92 .0.02 0 -. 10 -íkíH -M7 * SJ} 2 4..S2 -3.88 - .S2- -3.di -1 - &8S 4 &S2 0 £ 0 -3.T. -3.ee -3-32 ~ 4 < 92 -3.38 «3.S2 -3.31 -1« «3.83 -S-.92 0 0 -. 30 -®M -3.8S • 4 4S.92 -3 8 - ?. sz 3, íH -Í. & -Uß -3Ü < fifty € aiaacte 0 ftflß f? D $ til 011 -.O1 0.01 0.0T ú.dfr 0.6 ^ -2.0 -2.S? pïslon The first phase of the f ‡ flicjfcr & will drainage obstruct you to yerif ar? JUS the 'equips and not the catcher is the rescuer &' faith faith flight Time PosP Pdg-P PssP PcsP PmP Fesp Fa ^ P PesP P05P esP foürP PF5-P Transitional 0 5,1 »6.0 3S 529 S, 3 S, 52 S.YES 4.3 5.40 5.S4 5.97 second © 0 5.17 652 5.3 fi.1S 5, d 5.4 *» .9 5.48 5. S1 0.YES &03 1 * S 5.11 4.05 4.40 .ßa d.0d 4. -1.52 461 .ea ÍÍS'I 5.S7 s 4.46 • 1.9 »77, '16? 4.87 40? -1.41 4M? 4.57 9.9 SM-10 4.48 •?, 4.8 4.8S 4.4 $ ce ß 4.58 L3ÍÍ 4M 4.da S.SB s.ß & 2 $ 4AB < i.?8 447 46 4.71 4.SS 4.21 4.76- 4-.6Q S.S7 © 4A & 1.71 4-S1 446 4.61 4.07 4.d? Í 4.1G 4.71 4 < 57 6 Fall efe 0.71 ß.e! ? Oß3 ü? i M-5 1 3.92 0.74 §.77 0.90 0 3 -Í CJ3 Time ifeg ffc-gP Wení 'itaj f? EgP MogP Heg Hs > qp * «egP -NegP Hegf» NegP Trafiscurrt (Io 0> 3Jfl -3 6. $, 0 -SBS -3, S -3.03 -4M -2.23 -33? -S Fí -2.83 -J i «E_3ttfsdos 0 -4J 2 -3? -3 a sm -3.8U «331 -23« -3.91 -2.87 -2.72 I -S.íiß -188 -3.92 -2 -3.8C -3.02 -2.25 -3. € s «3 í -35 -fi3 -3-.S3 S.3S« 3.SS -2.IS W -3.Í4 -sfñ-s ~ Í -3-91 -3X '-3.S9 -2.3S -3 -US -3.SP4 -3.1? -3J1 -les - .sa -5-3S m -3.Sß -2.27 -3.04 -251 -3 Bá -3.83 -3Ü3 -S.S5 45.96 -Jf-3 -2.27 -1 4 Cßfd? s s. 001 G.12 üM -00 * 105 012 pressure c OTJ 4Í.Sß. ».85 Appendix B 2 of 4 13 14 15 16 I? 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Claims (42)

1. CLAIMS 1. A dialysis machine under the control of a processor, the machine consists of: an actuator unit configured to accept a disposable medical fluid cartridge that includes a flexible membrane, the cartridge is arranged to receive a medicinal fluid; a drive unit and the processor serving to: in a first integrity test, provide a positive pressure to an outer surface of the cartridge membrane and measure the fall of the positive pressure on the outer surface; and in a second integrity test it provides a positive pressure to an internal surface of the cartridge membrane and measures a drop in positive pressure on the inner surface. The dialysis machine of claim 1, wherein the positive pressure is provided in at least one of the first and second tests by means of a pneumatic source or a mechanical device. The dialysis machine of claim 2, which includes a sensor positioned in the pneumatic source to record the positive pressure drop. The dialysis machine of claim 1, wherein the positive pressure in the second integrity test is applied to at least a portion of the cartridge selected from the group consisting of: a pumping portion, a valve portion, a portion of port and a portion of flow path. 5. The dialysis machine of claim 1, wherein the positive pressure in the first integrity test is applied to a first portion of the outer surface of the membrane and the negative pressure is applied to a second portion of the outer surface of the membrane. membrane. The dialysis machine of claim 1, wherein the positive pressure in the first identity test is applied to a second portion of the outer surface of the membrane. The dialysis machine of claim 1, wherein the positive pressure in the second integrity test is applied to a first portion of the inner surface of the membrane and the negative pressure to a second portion of the inner surface of the membrane. membrane. The dialysis machine of claim 1, wherein the second integrity test is a first test in which the pressure is applied to an internal surface of the cartridge membrane and the pressure drop is measured, and which includes at least one additional integrity test in which at least one positive and negative pressure is applied to an internal surface of the cartridge membrane and at least the positive or negative pressure is measured. The dialysis machine of claim 1, wherein the second test occurs after the first test. The dialysis machine of claim 1, wherein at least one of the first and second tests triggers an alarm if the associated pressure drop does not meet a predetermined range. eleven . The dialysis machine of claim 1, wherein the same pressure source is used to create a positive pressure on the inner and outer surfaces of the membrane. 12. A dialysis machine under the control of a processor, the machine comprising: a drive unit configured to accept a disposable cartridge of a medicinal fluid, the cartridge has a plurality of fluid lines, each of the fluid lines are coated in such a way that the sterility of the air is maintained within the lines before being used in the treatment, the cartridge placed to receive a medicinal fluid; and wherein the drive unit and the processor serve to: (i) provide air pressure to the inner surface of the cartridge membrane and (ii) measure a pressure drop, (ii) while the fluid lines are coated and before any fluid line is connected to a fluid supply. 1 3. The dialysis machine of claim 12, wherein at least one of the fluid lines is surrounded by at least one device selected from the group consisting of a tip guard, a line clamp and a hydrophobic membrane. The dialysis machine of claim 12, wherein the drive unit and processor further serve to: (i) provide pressure to the inner surface and (ii) measure a pressure drop, (iii) while at least One of the fluid lines is connected to a fluid supply. 15. The dialysis machine of claim 14, wherein the applied pressure while the fluid line is connected to the fluid supply is air pressure or pressure. The dialysis machine of claim 12, wherein the pressure applied to the internal surface is at least either a positive air pressure or a negative air pressure. The dialysis machine of claim 16, wherein negative and positive pressures are provided at the same time. The dialysis machine of claim 12, wherein the pressure applied to the inner surface of the membrane is produced by applying a pressure to an outer surface of the membrane and manipulating at least one valve. The 9. The dialysis machine of claim 1, wherein the pressure applied to the outer surface of the membrane is at least one positive pressure or one negative pressure. The dialysis machine of claim 1, wherein the pressure is applied to a selected portion of the cartridge. twenty-one . The dialysis machine of claim 12, wherein the processor further serves to process an alarm signal if the measured pressure drop does not meet the present range. 22. An improved integrity testing method for a dialysis machine having a drive unit operating with a disposable cartridge, the method consists of: first examining a pressure support capability of the cartridge; and second, to examine the operation of the drive unit in the manner that a user can determine, after failure of a test, whether the failure is due to a failure in the cartridge or a failure in the drive unit. 23. The method of claim 22, wherein examining the pressure receiving capability of the cartridge includes performing a plurality of pressure drop tests. The method of claim 22, wherein examining the pressure receiving capability of the cartridge includes examining the pressure-bearing capacity of selected portions of the cartridge. 25. The method of claim 22, wherein examining the pressure receiving capacity of the cartridge in- cludes performing a pressure drop test using at least either positive or negative pressure. 26. The method of claim 22, wherein examining the pressure receiving capability of the cartridge includes performing a pressure drop test on the pressure applied to at least the outside or inside of the cartridge. The method of claim 22, wherein the examination of the operation of the drive unit includes examining at least the operation of the valve of the cartridge and the sealing operation of the pipe. 28. A method for priming a fluid line in communication with a fluid pump and a fluid bag located upstream of the pump, the method comprising: (a) pumping fluid through a portion of the fluid line; and (b) allow the rest of the fluid line to be primed by gravity. 29. The method of claim 28, including setting a fluid level in the bag and a distal end of the fluid line at substantially the same elevation height. 30. The method of claim 28, which includes closing an outlet valve downstream of the pump while opening an inlet valve upstream of the pump and using the pump to draw fluid from the bag into a pump chamber. of the bomb. 31 The method of claim 30, which includes closing the inlet valve, opening the outlet valve and pumping the fluid through a portion of the fluid line. 32. The method of claim 30, which includes opening the inlet and outlet valves and allowing the fluid in the bag to be fed by gravity to prime the remainder of the fluid line. 33 .. A method for priming a fluid line, in communication with a fluid pump and a fluid bag located upstream of the pump, the method comprises: (a) pumping fluid through a portion of the fluid line; and (b) detecting that a patient's clamp has not been adequately removed from the fluid line by recording a lack of an expected pressure drop after pumping the fluid through a portion of the fluid line. 34. The method of claim 33, which includes passing the air in the fluid line by pumping fluid through the portion of the fluid line. 35. A method for verifying the top height for a medical fluid system that includes a fluid supply and a fluid pump, the fluid pump includes a flexible membrane located within a pump chamber, the method consists of: (a ) filling by gravity at least a portion of the fluid pump with a supply fluid, the fluid moving the flexible membrane within the chamber; (b) measuring an air pressure in the chamber on an opposite side of the membrane that was moved by the fluid, the air pressure indicates the top height of the supply; and (c) determine if the upper height is acceptable. 36. The method of claim 35, wherein the pump is a first pump and the fluid supply is a first fluid supply and includes a second pump and a second fluid supply and performing the procedures (a) to (a) c) for the second bo; mba and the second fluid supply. 37. The method of claim 35, which includes providing an alarm if the top height is not acceptable. 38. The method of claim 35, wherein measuring the air pressure in the chamber includes calibrating a depression sensor when the air pressure on the opposite side of the membrane is expected to be zero. 39. A method to verify the upper height for the medical fluid system that includes a fluid drain and a fluid pump, the fluid pump includes a flexible membrane located inside a pump chamber, the method consists of: (a ) removing fluid from the fluid pump by draining the fluid by gravity, removing the fluid that moves the flexible membrane inside the chamber; (b) measuring an air pressure in the chamber on the opposite side of the membrane moved by the fluid, the pressure air indicates the upper height between the fluid pump and the fluid drain; and (c) determining whether the upper height is acceptable; 40. The method of claim 39, which includes providing an alarm if the head height is not acceptable. 41 The method of claim 39, wherein measuring the air pressure in the chamber includes calibrating a pressure sensor, before removing fluid from the fluid pump, when the air pressure on the opposite side of the membrane is measured. expect it to be zero. 42. The method of claim 39, wherein the air pressure in the chamber includes measuring a negative air pressure.