Baxter Arena User manual

4. Hydraulic Theory
TABLE OF CONTENTS
4. HYDRAULIC THEORY ..................................................3
4.1 Overview............................................................ 3
4.2 Dialysate Circuit................................................ 4
4.2.1 Incoming Water Pressure Regulator ............4
4.2.2 Water On/Off Valve.....................................5
4.2.3 Heat Exchanger............................................5
4.2.5 Concentrate Line Regulator(s) and Concentrate Central Delivery Systems
(optional)...................................................6
4.2.6 Volumetric Proportioning System ...............6
4.2.7 Supply Manifold ..........................................6
4.2.8 Air Removal System ....................................9
4.2.9 "A" & "B" Rinse Fittings .............................9
4.2.10 Supply Pump Recirculation Loop..............9
4.2.11 Input Pressure Equalizer, Flow Equalizer,
and Output Pressure Equalizer................12
4.2.12 End-of-Stroke Sensors .............................12
4.2.13 Dialysate Monitoring Manifold ................14
4.2.14 Dialysate Bypass Valve and Sensor.........16
4.2.15 Rinse Block..............................................17
4.2.16 Dialysate Sample Ports .............................17
4.3 Ultrafiltration System ..................................... 17
4.4 Blood Leak Detector....................................... 18
4.5 Other Components ......................................... 18
4.5.1 Rinse Valve................................................18
4.5.2 Heat Disinfection Recirculation Valve ......19
4.5.3 Citric Acid Valve Manifold (optional) ......19
Standard Hydraulics Flow Diagram ..................... 21
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4. HYDRAULIC THEORY
4.1 OVERVIEW
The Arena Instrument is designed to heat incoming water to approximately human body temperature, mix the water with dialysate concentrate in physiologically correct proportions and infuse the dialysate through an artificial kidney to effect hemodialysis therapy. In doing this, it also accurately measures the amount of fluid entering and exiting the artificial kidney and can adjust these volumes to control the fluid removal from the patient. Operation of the hydraulic components is controlled by several microprocessors. Refer to Figures 4-1 and 4-2 for the location of components in the Instrument and to the standard hydraulics diagram (157-1278-587) at the end of this section for thier sequence in the flow path.
4. Hydraulic Theory
Figure 4-1. Standard Hydraulics Module, Front View
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Figure 4-2. Standard Hydraulics Module, Rear View
4.2 DIALYSATE CIRCUIT
4.2.1 Incoming Water Pressure Regulator
The pressure of the incoming water is reduced and stabilized by the adjustable water pressure regulator to the factory­recommended level (see Section 18, Calibration Procedures).
Figure 4-3. Incoming Water Pressure Regulator
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4.2.2 Water On/Off Valve
This valve is actuated through a coil using unregulated +24 VDC. When the power is off, the valve is closed preventing water from entering the Instrument. When power is on, the on/off valve operation is controlled by the supply manifold level sensor signal. During heat cleaning, the valve is closed. This valve can be monitored using the DS1 “Flow Control” LED on the I/O Hydraulics Power board (see Section 5, Electronic Theory).
4.2.3 Heat Exchanger
Incoming water flows through a hydraulic channel on one side of a stainless steel plate. On the other side of the plate, the spent dialysate flows in a countercurrent direction in an identical hydraulic channel before draining out of the Instrument.
Heat is transferred from the spent dialysate to the incoming water through the plate. This heat transfer preheats the incoming water, shortening dialysate warm up time. By reducing the time the heater is on, the heat exchanger saves energy.
The heat exchanger allows the Instrument to be used with a wider range of incoming water temperatures since this preheating of the incoming water reduces these variations.
Figure 4-4. Heat Exchanger
4.2.4 Heater, Thermistor, Safety Thermostat
The water is heated to the desired temperature by a heater. On the output of the heater is a thermistor. The thermistor resistance changes in inverse proportion to temperature changes. The thermistor sends a signal to the UF-Proportioning Power board, which then turns the heater on or off to maintain or increase the temperature.
Next to the heater is a resettable thermostat, which prevents the heater from exceeding a temperature of approximately 107°C
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4.2.5 Concentrate Line Regulator(s) and Concentrate
4.2.6 Volumetric Proportioning System
(225°F). The thermostat turns off power to the heater to prevent damage in case of a runaway temperature circuit failure.
For testing purposes, the heater has a resistance of approximately 10-20 when cold. The thermistor has a resistance of approximately 3 K at 37 to 38°C and 5 K at 25°C.
Central Delivery Systems (optional)
Concentrate Line Regulators are recommended when a central delivery system is used to feed concentrates into the Instrument.
Refer to Section 7, Dialysate Preparation, for more information.
The Instrument's volumetric proportioning system consists of fixed volume pumps for concentrates and a fixed volume metering device (Flow Equalizer) for dialysate. They are linked electronically through the Ultrafiltration Controller to provide a fixed ratio proportioning system.
Refer to Section 7, Dialysate Preparation, and Section 8, Ultrafiltration, for more information.
4.2.7 Supply Manifold
The supply manifold controls the incoming water flow, mixes the “A” dialysate concentrate component, removes the dissolved air from the water, and monitors the “A” concentrate and water conductivity. The supply manifold is composed of four components:
“A” Mix Chamber and Air Gap
Air Removal Sprayer
Air Trap and Level Sensor
“A” Conductivity Probe/Thermistor Set
This manifold also contains the connections for the air removal pump, and the “A” and “B” rinse fittings that connect through a common line to the supply manifold and draw rinse water from this source.
The “A” concentrate pump is described in Section 7, Dialysate Preparation.
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Figure 4-5. Supply Manifold
4.2.7.1 “A” Mix Chamber and Air Gap
As the name implies, the “A” mix chamber mixes the water and “A” concentrate into a uniform solution.
The air gap at the top of this chamber is at atmospheric pressure, which helps to limit proportioning errors. The air gap also acts as a barrier preventing back flow in the event of a drop in the incoming water pressure.
4.2.7.2 Air Removal Sprayer
The sprayer is part of the air removal system. Refer to Section 7, Dialysate Preparation, for more information.
4.2.7.3 Air Trap and Level Sensor
The air trap and level sensor control the flow of water into the hydraulic system by causing the water on/off valve to open when the level drops and by closing the valve when the level rises.
The level sensor consists of a float with magnet and a Hall-effect switch. When the water level float magnet is below the sensor, the condition indicates the need for more water, opening the incoming
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water on/off valve. When the magnet is above the sensor, the condition indicates the air trap is full, closing the incoming water on/off valve.
In normal operation, as the supply pump draws solution from the air trap chamber to fill the flow equalizer, the liquid level in the chamber is lowered along with the float causing the water on/off valve to open so water again fills the chamber.
When the air trap level rises, the level sensor signal shuts off the water on/off valve. This cycle is repeated during every fill phase of the flow equalizer.
4.2.7.4 "A" Conductivity Probe/Thermistor Set
This is one of three conductivity probe sets. The other two are described in Section 4.2.10.3, "B" Conductivity Probe/Thermistor Set, and Section 4.2.13.1, Dialysate (Primary) Conductivity Probe/Thermistor Set.
Figure 4-6. "A" Probe/Thermistor Set
Conductivity is used as a measure of the electrolyte composition of dialysate. The hardware for measuring conductivity is always a cell for measuring changing resistance as the amount of dissolved salt changes and a thermistor for measuring temperature changes. Electronic circuits are used to equate these changing resistances to the standard measuring conditions of a 1 cm cell at 25 Celsius. The information from these devices can be used to give us
conductivity in the units of milliSiemens/cm (mS/cm) @ 25°C.
The “A” conductivity thermistor is not used to control or monitor the temperature of the dialysate. It is calibrated with the other thermistors during temperature calibration.
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4.2.8 Air Removal System
The air removal system removes dissolved gases that are trapped in the water used to make up dialysate. The air removal system consists of the air removal sprayer, the air removal pump, and the vented air trap.
The air removal sprayer nozzle restricts the flow so that a partial vacuum of approximately 500 to 650 mmHg is created in the air removal sprayer chamber. The fluid that passes through the air removal sprayer is deflected into a conical spray pattern. By developing a spray pattern, a larger surface area is exposed to the 500 to 650 mmHg vacuum. The vacuum pulls the air out of the solution. Due to the large surface area of fluid exposed to the vacuum, the rate at which the air comes out of the water is increased, enhancing the air removal function.
The air removal pump (also known as the deaeration pump) runs at a constant speed of approximately 1500 mL/min for all flow rates, pulling the solution through the air removal sprayer nozzle.
The vented air trap provides an opening for air to leave the system. For more information, refer to Section 4.2.7 and Section 7, Dialysate Preparation.
4.2.9 "A" & "B" Rinse Fittings
The “A” and “B” rinse fittings are located on the right side panel of the Instrument. Both fittings are connected to a source of water in the supply manifold. This water is used to rinse the concentrate lines and concentrate pumps.
A proximity sensor built into each of the rinse fittings senses when the concentrate lines are attached. The rinse fittings are keyed so that the “A” concentrate line will not fit into the “B” concentrate fitting and vice versa. When the “B” concentrate line is not in use during acetate dialysis or during rinse, it is connected to its rinse fitting.
4.2.10 Supply Pump Recirculation Loop
The supply pump recirculation loop mixes the “B” concentrate, monitors the total conductivity, regulates the pressure, and pumps dialysate to the flow equalizer. This loop contains the inlet for the “B” concentrate pump, the "B" (bicarbonate) mix chamber, the
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“B” conductivity probe, the supply pressure pump, and the supply pressure regulator. Figure 4-7 describes this loop.
The loop configuration helps to mix the bicarbonate concentrate by recirculating the solution through the “B” mix chamber. The loop also acts as a conduit for flow that is diverted by the supply pressure regulator at the end of each flow equalizer fill cycle.
Figure 4-7. Supply Pump Recirculation Loop
4.2.10.1 "B" Mix Point
Bicarbonate concentrate enters the water-acid concentrate mixture at the “B” mix point.
4.2.10.2 "B" Mix Chamber
During hemodialysis therapy, the solution that enters the “B” mix chamber from the supply manifold contains water and acetate concentrate, or water and the acid and bicarbonate components of bicarbonate dialysate (depending on the concentrates selected). This chamber mixes the solution before it is monitored by the “B” conductivity probe.
4.2.10.3 "B" Conductivity Probe/Thermistor Set
This is one of three conductivity probe sets. The other two are described in Section 4.2.7.4, "A" Conductivity Probe/Thermistor Set, and Section 4.2.13.1, Dialysate (Primary) Conductivity Probe/Thermistor Set.
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Figure 4-8. "B" Probe/Thermister Set
The second conductivity probe in the flow path is located at the outlet of the “B” mix chamber in the dialysate supply recirculation loop. The probe/thermistor set is identical to the “A” conductivity probe/thermistor set. In addition to compensating for temperature effect on the conductivity reading, the “B” thermistor is also the source of the temperature reading for the redundant high temperature alarm as well as fine-tuning the dialysate temperature control. Refer to Section 6, Temperature Control, for more information on temperature control.
The “B” probe monitors the total conductivity of the dialysate solution after both concentrates are mixed. The UF-Proportioning Controller board subtracts the “A” conductivity probe reading from the “B” conductivity probe reading and compares the difference to the expected result. In the acetate therapy mode, the result of this calculation should be zero and is used to recheck the “A” conductivity probe reading. When bicarbonate dialysate is used, the UF-Proportioning Controller board calculates whether the conductivity contribution of the “B” portion of the solution is acceptable for the type of bicarbonate concentrate used.
4.2.10.4 Supply Pump
The supply pump fills the flow equalizer with fluid. The supply pump pumps at a rate slightly higher than the dialysate flow rate set by the operator. This extra flow ensures an adequate supply of solution to fill the flow equalizer. For more information on the speed control of the supply pump, refer to Section 7, Dialysate Preparation.
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4.2.11 Input Pressure Equalizer, Flow Equalizer, and
4.2.12 End-of-Stroke Sensors
4.2.10.5 Supply Pressure Regulator
The supply pressure regulator controls the peak input pressure to the "pre" side of the input pressure equalizer. When the flow equalizer cavity is filled, the pressure in the pressure regulator increases to its maximum value (16 psi ±1), overcoming the spring force of the regulator spring allowing the dialysate to recirculate back to the “B” mix chamber. The Supply Pressure Regulator is equivalent to an adjustable pressure relief valve. See also Section 8, Ultrafiltration.
Output Pressure Equalizer
Refer to Section 8, Ultrafiltration, for a detailed description of these components.
The end-of-stroke (EOS) sensors are infrared optical devices located in the flow path after the Flow Equalizer and before the Output Pressure Equalizer. These sensors verify when the Flow Equalizer compartments have reached the end of the fill cycle. When the compartments are full, the sensor sends a signal to the UF-Proportioning Power board. The EOS sensors are used to minimize the end-of-stroke time of the Flow Equalizer by controlling the flow rate of the supply pump via feedback from the sensors.
The Instruments that have temperature-dependent EOS sensors, work with self-heating thermistors. The temperature of these thermistors will rise when the flow through them stops.
The Instrument may have optical EOS sensors like the one shown in Figure 4-9. (The diagrams in this section show the optical sensor.) The main components are two small PCBs, one on each side of the assembly, and one diaphragm right in the middle of the assembly. One PCB has the circuitry for the LED, and the other for the Detector. On the body of the assembly, the orientation of the diaphragm is indicated by a raised alignment symbol.
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Figure 4-9. Optical Sensor Assembly
The diaphragm has four flaps that will open under a pressure of 0.5 PSI, allowing the light from the LED to go across the assembly and reach the Detector (see Figure 4-10). This will indicate that dialysate is flowing. When the flow stops, the diaphragm will close, blocking the light from the LED, which indicates that the flow stopped.
A green LED on the Detector PCB will turn on when the Detector does not get any light.
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Figure 4-10. Optical/Diaphragm Sensors for EOS
4.2.13 Dialysate Monitoring Manifold
The purpose of this assembly is to house the components to monitor the dialysate temperature, conductivity and pressure. This manifold contains:
The dialysate (primary) conductivity probe/thermistor set
The dialysate pressure transducer
The bypass valve flow sensor
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Figure 4-11. Dialysate Monitoring Manifold
4.2.13.1 Dialysate (Primary) Conductivity Probe/Thermistor Set
This is one of three conductivity probe sets. The other two are described in Section 4.2.7.4, "A" Conductivity Probe/Thermistor Set, and Section 4.2.10.3, "B" Conductivity Probe/Thermistor Set.
Figure 4-12. "Primary" Probe /Thermistor Set
The third conductivity probe/thermistor set is located in the Dialysate Monitoring Manifold at the outlet of the output pressure
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4.2.14 Dialysate Bypass Valve and Sensor
equalizer. This probe set is identical to the other conductivity probe sets. It measures the total conductivity of the dialysate before it enters the artificial kidney. This temperature­compensated conductivity value is displayed in the CONDUCTIVITY window. The primary conductivity alarm circuit also uses the signal from this probe.
As mentioned previously, a thermistor is built into one of the electrodes. This thermistor supplies information for the temperature display and the primary high and low temperature alarm limits. For more information on temperature monitoring, refer to Section 6, Temperature Control.
4.2.13.2 Dialysate Pressure Transducer
This pressure transducer senses the dialysate pressure and changes the pressure reading into an analog electrical signal proportional to pressure. This signal is used for the transmembrane pressure display and alarms.
4.2.14.1 Bypass Valve
The bypass valve protects the patient in the event of a temperature or conductivity alarm by diverting unacceptable dialysate away from the dialyzer. The diverter is a +24 VDC three-way solenoid valve, controlled by the I/O Hydraulics Power board. During a dialysate temperature or conductivity alarm, an electronic signal causes the bypass valve to close the fluid path leading to the dialyzer and shunt the dialysate to the drain.
On the I/O Hydraulics Power Board, LED DS6 indicates Bypass (off) or Flow (on). See Figure 4-13 for location.
Figure 4-13. Bypass/Flow LED
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While in Rinse Mode, the Instrument will automatically go into Bypass Mode periodically.
There is also a manual Bypass Mode that permits the operator to put the Instrument in bypass when a dialyzer is connected or sequential ultrafiltration therapy is performed. This manual Bypass Mode is activated via the Bypass switch located on the Membrane Switch Panel.
4.2.14.2 Bypass Valve Flow Sensor
A temperature-dependent flow sensor connected (see Figure 4-11) to the dialysate monitoring manifold after the bypass valve is used to monitor dialysate flow. When the Instrument is in bypass, the bypass valve diverts the dialysate flow away from the dialyzer; therefore this sensor verifies the correct functioning of the bypass valve by detecting that no flow is going through the sensor. The Instrument generates a shutdown alarm in the event of a bypass valve failure.
The signal from the Flow Sensor is also used to indicate dialysate flow or bypass on the touchscreen display. Refer to Section 4.2.12 for more information on the sensor assembly.
4. Hydraulic Theory
4.2.15 Rinse Block
When the Instrument is not being used for a patient treatment and a dialyzer is not in use, the dialysate lines are attached to a rinse block. The rinse block has proximity sensors that are used to determine the placement of the dialyzer connectors and are used as interlocks for mode changes.
4.2.16 Dialysate Sample Ports
The sample ports (pre- and postdialyzer) are provided as an opening for the operator to obtain a sample of the dialysate to test for conductivity or residual disinfectant.
4.3 ULTRAFILTRATION SYSTEM
The ultrafiltration (UF) system allows the operator to remove a precise amount of fluid from a patient in a controlled manner. By controlling exactly how much dialysate is going to and returning from the dialyzer, accurate fluid removal is achieved.
The main components of the UF system are (as they appear in the flow path):
Supply Pump
150µ Particle Filter
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Supply Pressure Regulator
Input Pressure Equalizer
Flow Equalizer
Output Pressure Equalizer
Dialyzer Connectors and Dialyzer
Check Valve
Dialysate Pressure Pump
Flow Restrictor
UF Removal Regulator
UF Flow Meter
Refer to Section 8, Ultrafiltration Control, for more information on the UF System.
4.4 BLOOD LEAK DETECTOR
Spent dialysate expelled from the flow equalizer passes through and is monitored for the presence of blood in the blood leak detector. There is a light source and a photocell which monitors the light transmitted through the solution present in the cavity. If blood leaks through the dialyzer membrane, the blood passing through the blood leak detector will absorb a portion of the light, preventing it from reaching the photocell. The dimmed light then sets off a blood leak alarm and protects the patient by stopping the blood pump, clamping the venous line, and warning the operator. For more information, refer to Section 14, Blood Leak Detector.
4.5 OTHER COMPONENTS
4.5.1 Rinse Valve
The rinse valve (also called the dialysate pressure relief valve) connects to the fluid path immediately after the flow sensor on the downstream side of the dialyzer. When the Instrument is in the Rinse Mode, the electronics control the UF flow meter to meter 3.6 L/h of fluid out of the flow path. Fluid must be added to the system to prevent a vacuum from being built up in the flow path. The rinse valve allows fluid from the drain line to replace the volume removed by the UF flow meter.
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The rinse valve is open in the Rinse and Prime Modes, in Self Test (except UF test) and in the Calibration Mode when the UF Flow Meter is being calibrated. Therefore, when the dialyzer connectors are not connected to the Instrument, the rinse valve must be closed.
4.5.2 Heat Disinfection Recirculation Valve
The heat disinfection recirculation valve diverts the effluent water back into the input side of the heater (with the water on/off closed) in order to heat the water to above 84°C and maintain that fluid path temperature for the time set by the service technician. For more information, refer to Section 9, Disinfection.
4.5.3 Citric Acid Valve Manifold (optional)
This manifold is part of the Citric Acid option. It consists of a normally-closed two-way valve, which opens during the Citric Acid Heat Clean Mode if the dialyzer connectors are on the rinse block and citric acid is to be infused.
If the dialyzer connectors are removed from the rinse block during citric acid infusion, the citric acid valve will close, citric acid infusion will stop, and the message PLACE DIALYZER LINE ON RINSE BLOCK will be displayed.
For more information on the Citric Acid option, refer to Section 2, Physical Description, and Section 9, Disinfection.
Figure 4-14. Citric Acid Option Hardware
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