Fresenius 2008K User manual

FRESENIUS 2008K

HEMODIALYSIS SYSTEM

CALIBRATION

PROCEDURES

Part Number 507296 Rev. B

FRESENIUS MEDICAL CARE

NORTH AMERICA

2637 Shadelands Drive, Walnut Creek, CA 94598

800-227-2572 or 925-295-0200

REGIONAL EQUIPMENT SPECIALIST:___________________________________

FRESENIUS 2008K

HEMODIALYSIS SYSTEM

CALIBRATION

PROCEDURES

Part Number 507296 Rev B

WARNINGS

Shock hazard. Refer servicing to qualified personnel.

Never perform maintenance when a patient is connected to the machine. If possible, remove the machine from the treatment area when it is being serviced. Label the machine to ensure it is not accidentally returned to clinical use before the service work is completed. Always fully test the machine when maintenance is completed. Confirm dialysate conductivity and pH level before returning the machine to clinical use.

The electrical source must be 120 volts, 60 Hz, single phase. The outlet must be a three-conductor type with a hospital-grade receptacle and a ground fault interrupter. Test the polarity and ground integrity before installation and ensure it is maintained thereafter. Failure to do so may result in electrical shock to the operator or patient.

Calibration procedures must be performed using primary standards or by using standards that are regularly calibrated in a program traceable to the National Institute of Standards and Technology (National Bureau of Standards).

Calibrate the Level Detector module for the model of venous line being used. During calibration ensure the filter inside the drip chamber is below the sensor heads. Also verify that the venous clamp fully occludes the line when closed.

Failure to install, operate and maintain this equipment according to the manufacturer’s instructions may cause injury or death to the patient or the operator.

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CALIBRATION PROCEDURES

TABLE OF CONTENTS

1.0 INTRODUCTION..................................................................................................... 1

1.1 TEST EQUIPMENT NEEDED....................................................................................................... 2

1.2 OPERATING MODES................................................................................................................... 3

1.3 FRONT PANEL CONTROLS .......................................................................................................6

1.4 MEASURING FLUID VOLUMES..................................................................................................8

1.5 CALIBRATE IF REPLACED ........................................................................................................ 9

2.0 SERVICE MODE CALIBRATIONS ......................................................................... 10

2.1 TOUCH SCREEN CALIBRATION.............................................................................................. 10

2.2 HYDRAULIC CALIBRATION PROCEDURES........................................................................... 11

2.2.1 DEAERATION AND LOADING PRESSURE CALIBRATION............................................................ 12

2.2.2 FLOW PRESSURE CALIBRATION .................................................................................................. 14

2.2.3 BALANCE CHAMBER VOLUME CALIBRATION ............................................................................. 15

2.2.4 ACID (CONCENTRATE) PUMP VOLUME CALIBRATION .............................................................. 17

2.2.5 BICARBONATE PUMP VOLUME CALIBRATION ............................................................................ 19

2.2.6 UF PUMP VOLUME CALIBRATION................................................................................................. 21

2.3 SENSOR CALIBRATION PROCEDURES................................................................................. 24

2.3.1 ARTERIAL PRESSURE CALIBRATION........................................................................................... 25

2.3.2 VENOUS PRESSURE CALIBRATION ............................................................................................. 31

2.3.3 DIALYSATE PRESSURE CALIBRATION......................................................................................... 34

2.3.4 TEMPERATURE SENSOR CALIBRATION ...................................................................................... 36

2.3.5 POST TEMPERATURE SENSOR CALIBRATION ........................................................................... 38

2.3.6 TEMPERATURE CONTROL CALIBRATION ................................................................................... 40

2.3.6.1 TEMPERATURE CONTROL CALIBRATION (METHOD 1) ................................................... 41

2.3.6.2 TEMPERATURE CONTROL CALIBRATION (METHOD 2) ................................................... 44

2.3.6.3 TEMPERATURE CONTROL CALIBRATION (METHOD 3) ................................................... 48

2.3.6.4 TEMPERATURE CONTROL CALIBRATION (METHOD 4) ................................................... 51

2.3.7 BLOOD LEAK CALIBRATION ..........................................................................................................54

2.3.8 CONDUCTIVITY CELLS CALIBRATION.......................................................................................... 56

2.3.8.1 CONDUCTIVITY CELLS CALIBRATION (v2.16 or less)........................................................ 56

2.3.8.2 CONDUCTIVITY CELLS CALIBRATION (v2.25 or greater) ................................................... 58

2.4 MONITOR CALIBRATION PROCEDURES...............................................................................61

2.4.1 SET CLOCK...................................................................................................................................... 62

2.4.2 VOLTAGE DETECTION CALIBRATION .......................................................................................... 63

2.4.3 ARTERIAL PUMP RATE .................................................................................................................. 66

2.4.4 VENOUS PUMP RATE..................................................................................................................... 67

3.0 CALIBRATION PROCEDURES NOT PERFORMED IN SERVICE MODE ................. 68

3.1 INLET WATER PRESSURE REGULATOR CALIBRATION ..................................................... 68

3.2 LEVEL DETECTOR CALIBRATION .......................................................................................... 70

3.3 BLOOD PUMP CALIBRATION .................................................................................................. 72

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NOTE

This document is written for Fresenius 2008K Hemodialysis Systems using software versions

2.16 or later.

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1.0 INTRODUCTION

Calibration involves doing two things. One is making mechanical adjustments, both to the hydraulics and to the electronics. The other part of calibration is storing data in the electronic memory in the machine. The machine uses an EEPROM, which stores calibration data until it is purposely erased and replaced with new data. To store new data in the EEPROM, the machine is operated in Service mode as described in Section 1.2. Service mode also shows important data that is needed to make some of the mechanical adjustments.

Perform the calibration procedures only when needed following repairs, or if the machine fails the performance tests included in the Preventive Maintenance Procedures. Do not re-calibrate the machine routinely to verify normal operation. Instead, use the performance tests included in the Preventive Maintenance procedures to ensure the machine is working properly.

If the machine behaves erratically during calibration, perform the Preventive Maintenance procedures. Clogged filters, leaky O-rings and similar items routinely corrected during Preventive Maintenance are a common cause of intermittent problems. When preparing to re-calibrate the Blood Leak Detector, either perform a bleach rinse first or verify that it has been done recently. The bleach rinse is required to clean the detector tube.

Warning! Once a chemical rinse is performed, the only selection the machine will allow is a mandatory rinse. This information is stored on the functional board. Therefore, if the functional board and EEPROM are swapped out together when troubleshooting a calibration or machine problem, the machine must be rinsed prior to releasing it back into service.

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1.1 TEST EQUIPMENT NEEDED

The following supplies and test equipment are required to perform the calibration procedures.

Warning! All of the test equipment used must be maintained and calibrated regularly in accordance with NIST standards. In particular, the conductivity meter must meet the specifications given below. Failure to do so could result in injury or death to the patient or to the operator.

• Fresenius Test Kit (Fresenius part number 150034), which contains two

gauges with fittings and hoses for measuring loading pressure and deaeration pressure.

• Fresenius test connectors containing precision resistors that simulate the

thermistor resistance at various temperatures (Fresenius part number 190060).

• Dialysate meter to measure dialysate pressure, temperature and conductivity

at the ends of the dialysate lines. The meter must be capable of making pressure measurements of from -250 mmHg to +400 mmHg with an accuracy of at least ±2 mmHg up to ±200 mmHg and an accuracy of at least 1% and ±1 mmHg beyond ±200 mmHg. The temperature function of this meter must be accurate within 0.2°C from 20°C to 45°C and must be capable of measuring dialysate temperatures up to 85°C with an accuracy of at least ±4.0°C. The conductivity function of this meter must be accurate to within 0.1 mS over a range of 12 mS to 17 mS at a temperature of 25°C.

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• Stopwatch with a resolution to 0.01 second and an accuracy of 0.01% or

better.

• Fresenius Buret, 25ml capacity with 0.1ml graduations (Fresenius part

number 290104).

• Graduated cylinder: 100ml capacity with a tolerance of 0.60ml at 100ml or

better.

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• Digital Multimeter to measure dc voltage, ac voltage and resistance with an

accuracy of at least 1% + 1 digit for dc voltage measurements 1.5% + 5 digits for ac measurements and 1% + 1 digit for resistance measurements.

• Syringe, 60 cc capacity. Tolerance is not important; the syringe is not used

for volume measurements.

For machines equipped with the blood pressure module, the following equipment is also required to test the module as described in this manual:

• Test Device (Fresenius part number 370090). The Test Device contains two

air chambers with calibrated volumes.

• Mercury manometer or equivalent pressure meter accurate to within 1

mmHg at pressures up to 335 mmHg.

1.2 OPERATING MODES

The following calibration procedures contain instructions to place the 2008K into Dialysis Mode and Service Mode.

To place the machine in Service Mode, turn the machine power On and wait for the message Press CONFIRM for Service Mode to appear. Once it appears, press the [CONFIRM] key and the message will change to Machine in Service Mode. After the System Initializing process is complete, the machine will be in Service Mode.

If the [CONFIRM] key is not pressed when the Press CONFIRM for Service

Mode message is on the screen, the screen will change and the message Machine in Dialysis Mode will appear. After the System Initializing process is complete,

the machine will be in Dialysis Mode.

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Upon power up in Service Mode, the following screen will appear on the front panel display:

Select a calibration by touching the appropriate calibration button.

Calibration procedures that have a red button must be completed before the machine will operate in Dialysis mode.

Select the desired calibration, then press the [CONFIRM] key to begin the procedure.

Caution: Once a calibration procedure is begun, pressing the [CONFIRM] key usually updates the calibration data in the EEPROM. Be careful not to press the [CONFIRM] key unless you want to change the calibration data. To leave a calibration procedure without changing the data in the EEPROM, press the [Escape] key.

A safety feature in the machine helps prevent mis-calibration. If a calibration value outside of acceptable limits is entered, the machine will reject the calibration data and the message OPERATOR ERROR will appear on the display screen. The data stored in the EEPROM will not be changed if this message appears.

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)

DEAERATION

(DEGAS) PUMP

CONNECTOR

MON-NTC

CONNECTOR

NTC-POST

CONNECTOR

#44

ADJUSTMENT

#20

UF PUMP

FLOW PUMP

BYPASS VALVE

FLOW PUMP

OUTLET

BLOOD PRESSURE MODULE

INLET REGULATOR (61

DRAIN PORT

PRESSURE RELIEF VALV

RELIEF VALVE (65

DEAERATION PUMP BYPASS VALVE

DEAERATION PUMP INLET

E (78)

Figure 1 - 2008K Rear View

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1.3 FRONT PANEL CONTROLS

The front panel consists of two areas, the touch screen and the control panel. The touch screen is the area under the glass in the center of the front panel. The control panel surrounds the touch screen and it contains the membrane keys. The following illustrates these areas:

Touch Screen

Figure 2 - 2008K Front Panel

Control Panel

Control Panel Operation

Throughout the calibration procedures, whenever a control panel key is to be pressed, the appropriate key name is surrounded by square brackets as in the following example:

Press the [CONFIRM] key and the screen will change.

In this example, the [CONFIRM] key on the control panel should be pressed.

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Touch Screen Operation

The touch screen is designed to display information and is used to enter data. To select a button during a procedure, locate the button on the screen and touch it. Depending on the type of button, the screen will change. Data boxes are also displayed on the touch screen. The following describes the type of buttons and data boxes that will be encountered during the calibration process.

Data Button

A yellow data button is used during calibration to enter a measured volume or value. When the yellow area of the data button is touched, it will change to a darker yellow. The data can be changed using the [

=] or [>] keys or the value can be

entered using the number keys both on the control panel. Once the data is entered, press the [CONFIRM] key and the data button changes back to light yellow. The [Escape] key can be pressed when the data button is dark yellow to abort the data entry and return it to light yellow. The entered data does not get stored until the [CONFIRM] key is pressed.

A gray data button means the button is not active and touching it will have no effect.

Screen Button

Blue rectangles on the touch screen are screen buttons. By touching the blue area of the screen button the display will either change to another screen or the selection of an option will change. A screen button is not active if it is gray.

Data Box

This type of box shows selected data or data the machine is measuring. During the calibration process this type of box is used to verify a value or selection.

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1.4 MEASURING FLUID VOLUMES

Several of the following procedures require measuring fluid volumes using graduated cylinders and laboratory burets. When making these measurements do the following:

• Make certain the container is clean and dry before collecting the fluid to be

measured. Two drops of fluid are approximately 0.1ml, which is enough to affect the accuracy of critical measurements.

• Ensure that no items such as thermometers or tubing are allowed to come in

contact with the fluid in the graduate. Such items will change the calibration of the graduate and affect the accuracy of measurements. Both the total volume indicated and the amount of fluid indicated by each increment on the graduated scale will be incorrect. For example, if a graduate is calibrated in 1ml increments, a piece of tubing in contact with the fluid will cause each increment to be less than 1ml, depending upon the total volume of the tubing that penetrates into the fluid.

• Surface tension causes the fluid to curve into a meniscus (see Figure 3).

Measure the volume at the bottom of the meniscus curve as shown.

100

BOTTOM OF THE MENISCUS CURVE

Figure 3 - Meniscus Curve

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1.5 CALIBRATE IF REPLACED

During the process of servicing a machine, components may need to be replaced. The following table shows calibrations that must be conducted after replacing certain components.

Replaced Component

- Deaeration Pump Head

- Deaeration Motor (or rebuild)

- Loading Pressure Relief Valve

- Flow Pump Head

- Flow Motor (or rebuild)

- Flow Pressure Relief Valve

- Balance Chamber - Balance Chamber Volume Sec. 2.2.3

- Acid Pump - Acid Pump Volume Sec. 2.2.4

- Bicarbonate Pump - Bicarbonate Pump Volume Sec. 2.2.5

- UF Pump - UF Pump Volume Sec. 2.2.6

- Dialysate Pressure Transducer - Dialysate Pressure Sec. 2.3.3

- Temperature Sensor

- Heater Bar

- Blood Leak Detector - Blood Leak Sec. 2.3.7

- Conductivity Cell - Conductivity Sec. 2.3.8

- Functional Board (New EEPROM) - All Calibrations All Sections

- Sensor Board

Then Calibrate

- Deaeration & Loading Pressure Sec. 2.2.1

- Flow Pressure Sec. 2.2.2

- Temperature Control Sec. 2.3.6

- Arterial Pressure Sec. 2.3.1

- Venous Pressure Sec. 2.3.2

- Dialysate Pressure Sec. 2.3.3

- Temperature Sec. 2.3.6

- Blood Leak Sec. 2.3.7

- Conductivity Sec. 2.3.8

- Arterial Pump Rate Sec. 2.4.3

- Venous Pump Rate Sec. 2.4.4

Refer to:

- Blood Pump Module

- Level Detector Module

Fresenius 2008K Calibration Procedures

- Arterial Pressure Sec. 2.3.1

- Arterial Pump Rate Sec. 2.4.3

- Venous Pressure Sec. 2.3.2

- Level Detector Sec. 3.2

Table 1 - Calibrate if Replaced

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2.0 SERVICE MODE CALIBRATIONS

Place the machine in Service Mode as described in Section 1.2 to perform the following procedures. The procedures do not have to be completed in any particular order. Go directly to the calibration procedures needed.

If calibration is being performed after working on the hydraulics unit, especially if the inlet water pressure regulator has been changed, we recommend that you calibrate the inlet water pressure regulator as described in Section 3.1 first.

2.1 TOUCH SCREEN CALIBRATION

The touch screen is calibrated from the Service Mode screen.

- Press the [New Tx] key to begin the touch screen calibration.

Note: The touch screen needs to be calibrated only when the machine is installed or if the touch screen is replaced.

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- Touch the asterisk on the screen. Another asterisk will appear in a different

spot on the screen. There are a total of three asterisks that will appear. Touch each asterisk as they appear. When the calibration is complete, the screen will prompt you to power the machine off.

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2.2 HYDRAULIC CALIBRATION PROCEDURES

From the Service Mode screen, select the Calibrate Hydraulics screen button. The following screen will appear showing the six hydraulic calibrations:

Perform the following calibrations in the order listed below. To begin a calibration, touch the appropriate calibration screen button.

• Deaeration Pressure

• Flow Pressure

• Balance Chamber

• Acid Pump Volume

• Bicarbonate Pump Volume

• UF Pump Volume

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2.2.1 DEAERATION AND LOADING PRESSURE CALIBRATION

From the Calibrate Hydraulics screen, select the Deaeration Pressure screen button. The screen will change to the following:

1. Connect a gauge in line at the inlet side of the deaeration pump (See Figure 1,

pg. 5).

Note: The inlet side of the deaeration pump is the side with the clear plastic line. The output side has a white reinforced jacket over the line.

2. Connect a gauge equipped with a yellow connector into the red ACETATE/ACID port.

3. Press the [CONFIRM] key. The deaeration pump will start and the screen will change.

4. Select the PUMP RATE data button.

Set the PUMP RATE value to 180, then press the [CONFIRM] key.

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5. Adjust the deaeration pump bypass valve (See Figure 1, pg. 5) on the

deaeration pump for a reading of -24 inHg on the gauge attached to the deaeration pump. The gauge needle will be wiggling slightly. Set the pressure so the maximum value is -24 inHg and verify that the needle does not go below -25 inHg. If these values cannot be reached, set the deaeration pump bypass valve for the closest reading possible, then select a higher PUMP RATE value until the proper pressure is indicated on the gauge.

6. The loading pressure gauge in the red RINSE port will be cycling between

two pressure levels. Adjust pressure relief valve #65 (See Figure 1, pg. 5) for a reading between 18 and 20 psi when the gauge is reading its highest pressure level. Verify that the pressure is greater than 10 psi at the lowest level, and that it is stable within 1 psi at each level.

Note: If a DIASAFE valve #65 for a reading between 23 and 25 psi when the gauge is reading its highest pressure level.

7. Repeat steps 5 and 6 until both readings are correct without further

adjustment.

8. Press the [CONFIRM] key to save the data. The screen will change.

Remove the gauges.

Press the [CONFIRM] key to complete the calibration and return to the Calibrate Hydraulics screen.



filter system is installed, adjust pressure relief

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2.2.2 FLOW PRESSURE CALIBRATION

From the Calibrate Hydraulics screen, select the Flow Pressure screen button. The screen will change to the following:

1. Connect a gauge in line at the output of the flow pump (See Figure 1, pg. 5).

Note: The output side of the flow pump is the side with the white reinforced jacket over the line. The input side has clear plastic line

2. Press the [CONFIRM] key to start the flow pump.

Locate the flow bypass screw on the back of the flow pump (See Figure 1, pg. 5). Turn the flow bypass screw all the way in (clockwise), then back it out two turns.

3. Adjust pressure relief valve #78 (See Figure 1, pg. 5) for a pressure between 29 and 30 psi indicated on the gauge.

Note: If a DIASAFE valve #78 for a pressure between 35 and 36 psi.



filter system is installed adjust pressure relief

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4. Press the [CONFIRM] key to complete the calibration and return to the Calibrate Hydraulics screen.

Remove the gauge from the flow pump output.

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2.2.3 BALANCE CHAMBER VOLUME CALIBRATION

The balance chamber volume is measured at the factory with a high degree of accuracy using equipment usually not available in the field. The chamber volume will not change in use. Record the factory-measured chamber volume for reference should the value need to the replaced in the EEPROM. Only perform the following procedure if the factory-measured volume has been lost, or if the balance chamber has been repaired or replaced.

From the Calibrate Hydraulics screen, select the Balance Chamber screen button. The screen will change to the following:

Note: Be prepared to remove the drain hose from the back of the machine (See Figure 1, pg. 5) and to collect fluid from the drain port with an empty 100ml graduated cylinder.

1. Press the [Prime] key to prime the balance chamber if needed. Press the [Prime] key again to stop this optional priming.

2. Press the [CONFIRM] key to start the calibration. The status box will change indicating the balance chamber is being prepared.

Once the balance chamber has been prepared, the screen will change and a progress bar will begin to fill from left to right. This bar is showing an approximate 15-second countdown before the contents of the balance chambers are dispensed from the drain port with two pulses of fluid.

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3. While this process is going on, remove the drain hose from the back of the

machine.

4. Prepare to catch the two pulses of fluid in the empty graduated cylinder by

placing it under the drain port.

5. As soon as the progress bar is completely blue, the machine will dispense

the two pulses out the drain port.

6. Place the graduated cylinder on a level surface and read the volume of fluid

it contains.

Select the BC Volume data button.

Set the BC Volume value to the amount collected in the graduated cylinder and then press the [CONFIRM] key.

7. Press the [CONFIRM] key again to store the data. The screen will change.

Replace the drain hose on the drain port.

Press the [CONFIRM] key to complete the calibration and return to the Calibrate Hydraulics screen.

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2.2.4 ACID (CONCENTRATE) PUMP VOLUME CALIBRATION

From the Calibrate Hydraulics screen, select the Acid Pump Volume screen button. The screen will change to the following:

1. Fill a 25ml buret with treated water or concentrate.

2. Attach the buret to the red concentrate line with a piece of tubing.

3. Press the [Prime] key. The acid pump will begin to stroke. Allow the pump to stroke about 20 times or more to remove the air from the line then press the [Prime] key again to stop the pump.

4. Select the Target data button.

Set the Target value to 30 strokes, then press the [CONFIRM] key.

5. Refill the buret exactly to the full (0ml) mark.

Press the [CONFIRM] key. The acid pump will stroke and the screen will change.

6. Wait until the Target value reaches zero.

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7. When the Target value reaches zero, the acid pump stops stroking.

Select the Volume data button.

Set the Volume value to the measured volume, then press the [CONFIRM] key.

8. Press the [CONFIRM] key again and the screen will change.

9. Refill the buret exactly to the full (0ml) mark.

Caution: Be sure the buret did not run out of fluid and allow air to be pulled into the machine.

10. If needed, prime the line by pressing the [Prime] key. The acid pump will

begin to stroke. Allow the pump to stroke about 20 times or more to remove the air from the line then press the [Prime] key again to stop the pump.

11. Select the Target data button.

Set the Target value to 30 strokes, then press the [CONFIRM] key.

12. Refill the buret exactly to the full (0ml) mark.

Press the [CONFIRM] key again. The acid pump will stroke and the screen will change.

13. Wait until the Target value reaches zero.

14. When the Target value reaches zero, the acid pump stops stroking.

Select the Volume data button.

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Set the Volume value to the measured volume, then press the [CONFIRM] key.

15. Press the [CONFIRM] key again to save the data. The screen will change.

Press the [CONFIRM] key one more time to complete the calibration and return to the Calibrate Hydraulics screen.

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2.2.5 BICARBONATE PUMP VOLUME CALIBRATION

From the Calibrate Hydraulics screen, select the Bic Pump Volume screen button. The screen will change to the following:

1. Fill a 25ml buret with treated water or concentrate.

2. Attach the buret to the blue bicarbonate line with a piece of tubing.

3. Press the [Prime] key. The bicarbonate pump will begin to stroke.

Allow the pump to stroke about 20 times or more to remove the air from the line then press the [Prime] key again to stop the pump.

4. Select the Target data button.

Set the Target value to 30 strokes, then press the [CONFIRM] key.

5. Refill the buret exactly to the full (0ml) mark.

Press the [CONFIRM] key. The bicarbonate pump will stroke and the screen will change.

6. Wait until the Target value reaches zero.

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7. When the Target value reaches zero, the bicarbonate pump stops stroking.

Select the Volume data button.

Set the Volume value to the measured volume, then press the [CONFIRM] key.

8. Press the [CONFIRM] key again and the screen will change.

9. Refill the buret exactly to the full (0ml) mark.

Caution: Be sure the buret did not run out of fluid and allow air to be pulled into the machine.

10. If needed, prime the line by pressing the [Prime] key. The acid pump will

begin to stroke. Allow the pump to stroke about 20 times or more to remove the air from the line then press the [Prime] key again to stop the pump.

11. Select the Target data button.

Set the Target value to 30 strokes, then press the [CONFIRM] key.

12. Refill the buret exactly to the full (0ml) mark.

Press the [CONFIRM] key again. The bicarbonate pump will stroke and the screen will change.

13. Wait until the Target value reaches zero.

14. When the Target value reaches zero, the bicarbonate pump stops stroking.

Select the Volume data button.

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Set the Volume value to the measured volume, then press the [CONFIRM] key.

15. Press the [CONFIRM] key again to save the data. The screen will change.

Press the [CONFIRM] key one more time to complete the calibration and return to the Calibrate Hydraulics screen.

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