2008K2 Cal Procedures (508137 Rev E)
2008K2 Cal Procedures (508137 Rev E)
2008K2 Cal Procedures (508137 Rev E)
HEMODIALYSIS
SYSTEM
CALIBRATION
PROCEDURES
Manufactured by:
Fresenius USA, Inc.
2637 Shadelands Drive
Walnut Creek, CA 94598
CALIBRATION
PROCEDURES
http://www.fmcna.com
Copyright 2008 - 2012 Fresenius Medical Care North America, All Rights Reserved
WARNINGS
Shock hazard. Refer servicing to qualified personnel.
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.
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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 .................................................................................................. 9
1.5 CALIBRATE IF REPLACED ....................................................................................................... 10
2.0 SERVICE MODE CALIBRATIONS ......................................................................... 11
2.1 HYDRAULIC CALIBRATION PROCEDURES ........................................................................... 12
2.1.1 DEAERATION AND LOADING PRESSURE CALIBRATION ............................................................ 13
2.1.2 FLOW PRESSURE CALIBRATION .................................................................................................. 16
2.1.3 BALANCE CHAMBER VOLUME CALIBRATION .............................................................................. 17
2.1.4 ACID (CONCENTRATE) PUMP VOLUME CALIBRATION ............................................................... 19
2.1.5 BICARBONATE PUMP VOLUME CALIBRATION ............................................................................ 21
2.1.6 UF PUMP VOLUME CALIBRATION ................................................................................................. 23
2.2 SENSOR CALIBRATION PROCEDURES ................................................................................. 26
2.2.1 ARTERIAL PRESSURE CALIBRATION ........................................................................................... 27
2.2.2 VENOUS PRESSURE CALIBRATION ............................................................................................. 33
2.2.3 DIALYSATE PRESSURE CALIBRATION ......................................................................................... 36
2.2.4 TEMPERATURE SENSOR CALIBRATION ...................................................................................... 38
2.2.5 POST TEMPERATURE SENSOR CALIBRATION............................................................................ 40
2.2.6 TEMPERATURE CONTROL CALIBRATION .................................................................................... 42
2.2.6.1 TEMPERATURE CONTROL CALIBRATION (METHOD 1) ................................................... 43
2.2.6.2 TEMPERATURE CONTROL CALIBRATION (METHOD 2) ................................................... 46
2.2.6.3 TEMPERATURE CONTROL CALIBRATION (METHOD 3) ................................................... 50
2.2.6.4 TEMPERATURE CONTROL CALIBRATION (METHOD 4) ................................................... 53
2.2.7 BLOOD LEAK CALIBRATION .......................................................................................................... 56
2.2.8 CONDUCTIVITY CELLS CALIBRATION .......................................................................................... 58
2.3 MONITOR CALIBRATION PROCEDURES ............................................................................... 61
2.3.1 SET CLOCK...................................................................................................................................... 62
2.3.2 VOLTAGE DETECTION CALIBRATION ........................................................................................... 63
2.3.3 ARTERIAL PUMP RATE ................................................................................................................... 66
2.3.4 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 2008K2
Hemodialysis Systems using software versions
5.10 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.
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! Test equipment used must be maintained and/or calibrated per the test
equipment manufacturer’s requirements. In particular, the dialysate meter must
meet the specifications listed below. Refer to the test equipment's' operator's
manual, or contact the manufacturer for calibration and maintenance requirements.
Failure to properly maintain and calibrate test equipment could lead to improper
calibration and/or failure of the device to meet its specifications.
Fresenius Test Kit (Fresenius part number 150034), which contains two
gauges with fittings and hoses for measuring loading pressure and
deaeration pressure.
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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.
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.
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:
Choose a calibration by selecting1 the appropriate screen key directly below the
calibration button. A second row of buttons will appear above the first.
Note: Calibration procedures that have a red button must be completed before
the machine will operate in Dialysis mode.
Select1 the desired calibration, then press the [CONFIRM] key to begin the
procedure.
1
Refer to Section 1.3 on the use of screen buttons.
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DEAERATION BLOOD PRESSURE
(DEGAS) PUMP MODULE
CONNECTOR
#20
MON-NTC
CONNECTOR
#3 DRAIN PORT
NTC-POST
CONNECTOR
#44
PRESSURE
RELIEF VALVE (78)
UF PUMP
ADJUSTMENT
FLOW PUMP
BYPASS RELIEF VALVE (65)
VALVE
DEAERATION PUMP
FLOW PUMP BYPASS VALVE
OUTLET
DEAERATION
PUMP INLET
2
Figure 1 - 2008K Rear View
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1.3 FRONT PANEL CONTROLS
The front panel consists of many areas. The following illustrates these areas:
In this example, the CONFIRM key on the control panel should be pressed.
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Screen Operation
The screen is designed to display information and is used to enter data. 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 highlighted and the [CONFIRM] key is pressed, it will
change to a darker yellow. The data can be changed using the
[] and [▬] data entry 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.
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Screen Button (menu selection)
Some screen buttons will display a menu of choices. To display the menu, use the
navigation keys ([],[],[◄], and [►]) to highlight the screen button and press the
[CONFIRM] key. The menu will be displayed with the current selection highlighted.
Use the [] and [▬] data entry keys to scroll the menu list and highlight a new
selection. Once a new selection is highlighted, press the [CONFIRM] key and the
selection is stored and the menu list disappears. If, after the menu is displayed, a new
selection is not required, press the [Escape] key to keep the current selection and
make the menu disappear.
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.
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
mL
90
BOTTOM OF
THE MENISCUS
CURVE
80
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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 Then Calibrate Refer to:
- Deaeration Pump Head
- Deaeration Motor (or rebuild) - Deaeration & Loading Pressure Sec. 2.1.1
- Loading Pressure Relief Valve
- Flow Pump Head
- Flow Motor (or rebuild) - Flow Pressure Sec. 2.1.2
- Flow Pressure Relief Valve
- Balance Chamber - Balance Chamber Volume Sec. 2.1.3
- Acid Pump - Acid Pump Volume Sec. 2.1.4
- Bicarbonate Pump - Bicarbonate Pump Volume Sec. 2.1.5
- UF Pump - UF Pump Volume Sec. 2.1.6
- Dialysate Pressure Transducer - Dialysate Pressure Sec. 2.2.3
- Temperature Sensor
- Temperature Control Sec. 2.2.6
- Heater Bar
- Blood Leak Detector - Blood Leak Sec. 2.2.7
- Conductivity Cell - Conductivity Sec. 2.2.8
- Functional Board (New EEPROM) - All Calibrations All Sections
- Actuator/Test Combo Board - Voltage Detection Sec. 2.3.2
- Arterial Pressure Sec. 2.2.1
- Venous Pressure Sec. 2.2.2
- Dialysate Pressure Sec. 2.2.3
- Temperature Sensor Sec. 2.2.4
- Post Temperature Sensor Sec. 2.2.5
- Sensor Board
- Temperature Sec. 2.2.6
- Blood Leak Sec. 2.2.7
- Conductivity Sec. 2.2.8
- Arterial Pump Rate Sec. 2.3.3
- Venous Pump Rate Sec. 2.3.4
- Arterial Pressure Sec. 2.2.1
- Blood Pump Module
- Arterial Pump Rate Sec. 2.3.3
- Venous Pressure Sec. 2.2.2
- Level Detector Module
- Level Detector Sec. 3.2
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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.
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2.1 HYDRAULIC CALIBRATION PROCEDURES
From the Service Mode screen, select1 the Calibrate Hydraulics screen tab
button. The following screen will appear showing the six hydraulic calibrations:
Deaeration Pressure
Flow Pressure
Balance Chamber
UF Pump Volume
1
Refer to Section 1.3 on the use of screen buttons.
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2.1.1 DEAERATION AND LOADING PRESSURE CALIBRATION
From the Calibrate Hydraulics screen, select1 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.
3. Press the [CONFIRM] key. The deaeration pump will start and the screen
will change.
1
Refer to Section 1.3 on the use of screen buttons.
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4. Select1 the PUMP RATE data button.
If the pressure is unable to be achieved and the PUMP RATE is at its limit,
adjust the bypass screw by turning it clockwise towards its closed position.
Caution: Do not over-tighten the bypass screw once the screw is in its
fully closed position. Permanent pump head damage could result.
Note: When the machine is at a different elevation above sea level, it may
be difficult or impossible to achieve -24inHg. The following table will help
in determining the appropriate deaeration pressure calibration point at
different elevations:
1
Refer to Section 1.3 on the use of screen buttons.
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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.
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.
Press the [CONFIRM] key to complete the calibration and return to the
Calibrate Hydraulics screen.
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2.1.2 FLOW PRESSURE CALIBRATION
From the Calibrate Hydraulics screen, select1 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
4. Press the [CONFIRM] key to complete the calibration and return to the
Calibrate Hydraulics screen.
1
Refer to Section 1.3 on the use of screen buttons.
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2.1.3 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, select1 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.
1
Refer to Section 1.3 on the use of screen buttons.
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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.
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.
Press the [CONFIRM] key to complete the calibration and return to the
Calibrate Hydraulics screen.
1
Refer to Section 1.3 on the use of screen buttons.
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2.1.4 ACID (CONCENTRATE) PUMP VOLUME CALIBRATION
From the Calibrate Hydraulics screen, select1 the Acid Pump Volume screen
button. The screen will change to the following:
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.
Set the Target value to 30 strokes, then press the [CONFIRM] key.
Press the [CONFIRM] key. The acid pump will stroke and the screen will
change.
1
Refer to Section 1.3 on the use of screen buttons.
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7. When the Target value reaches zero, the acid pump stops stroking.
Set the Volume value to the measured volume, then press the [CONFIRM] key.
8. Press the [CONFIRM] key again and the screen will change.
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.
Set the Target value to 30 strokes, then press the [CONFIRM] key.
Press the [CONFIRM] key again. The acid pump will stroke and the screen
will change.
14. When the Target value reaches zero, the acid pump stops stroking.
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.
1
Refer to Section 1.3 on the use of screen buttons.
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2.1.5 BICARBONATE PUMP VOLUME CALIBRATION
From the Calibrate Hydraulics screen, select1 the Bic Pump Volume screen
button. The screen will change to the following:
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.
Set the Target value to 30 strokes, then press the [CONFIRM] key.
Press the [CONFIRM] key. The bicarbonate pump will stroke and the
screen will change.
1
Refer to Section 1.3 on the use of screen buttons.
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7. When the Target value reaches zero, the bicarbonate pump stops stroking.
Set the Volume value to the measured volume, then press the [CONFIRM] key.
8. Press the [CONFIRM] key again and the screen will change.
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.
Set the Target value to 30 strokes, then press the [CONFIRM] key.
Press the [CONFIRM] key again. The bicarbonate pump will stroke and
the screen will change.
14. When the Target value reaches zero, the bicarbonate pump stops stroking.
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.
1
Refer to Section 1.3 on the use of screen buttons.
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2.1.6 UF PUMP VOLUME CALIBRATION
From the Calibrate Hydraulics screen, select1 the UF Pump Volume screen
button. The screen will change to the following:
1. Remove the dialysate lines from the shunt and place them in a bucket of
water.
2. Press the [CONFIRM] key to start the calibration. The screen will change.
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.
Add or remove fluid from the buret so the meniscus is exactly on the 25ml
mark (see Figure 4).
1
Refer to Section 1.3 on the use of screen buttons.
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ml 0
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8. When the Target value reaches zero, the UF pump will stop. Measure the
fluid collected in the buret. The buret scale should indicate between 0.90
and 1.10ml, indicating that between 23.90 and 24.10ml of fluid was
collected (see Figure 4). If the volume collected is not within this range,
adjust the UF pump volume as follows:
On the rear center of the hydraulics assembly, remove the plastic cap
covering the pump adjustment screw (See Figure 1, pg. 5).
Loosen the locking nut and turn the screw clockwise to decrease or counter-
clockwise to increase the pump volume.
Tighten the locking nut while holding the adjustment screw with
screwdriver before proceeding.
Press the [Escape] key and repeat the UF Pump Volume calibration until
the fluid fills the buret to between 0.90 and 1.10 on the scale after 24 strokes
of the UF pump.
Press the [CONFIRM] key to complete the calibration and return to the
Calibrate Hydraulics screen.
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2.2 SENSOR CALIBRATION PROCEDURES
From the Service Mode screen, select1 the Calibrate Sensors screen button.
The following screen will appear showing the eight sensor calibrations:
Arterial Pressure
Venous Pressure
Dialysate Pressure
Temperature Sensor
Temperature Control
Conductivity Cells
1
Refer to Section 1.3 on the use of screen buttons.
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2.2.1 ARTERIAL PRESSURE CALIBRATION
The arterial blood pump does not use potentiometers to calibrate the arterial pressure.
Instead, it stores a value in the blood pump. In order to calibrate the arterial pressure,
the pump must be put into its own service mode. This is done by moving the Service
Jumper located on the blood pump LP955 board. Refer to Figure 5 for location and
positioning of the Service Jumper.
Note: The DIP switches and Service Jumper on the blood pump must be set
prior to turning the machine ON.
LP955 Dip
MONITOR
switch Description
SERVICE
GND
5 Not Used
SERVICE
6 Not Used
ON/OFF
7 Not Used
ON for tubing diameter selection 2 to 10mm
(0.2mm increments)
OFF
ON
8
OFF for tubing diameter selection 2.6, 4.8,
6.4 and 8.0mm only
ON/OFF ON/OFF
SERVICE SERVICE
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The following procedure calibrates the pressure sensor on the arterial blood pump.
- With the machine turned OFF, position the blood pump Service Jumper into
the In Service Mode position.
- Locate DIP switch 2 on the blood pump LP955 board and configure it as
follows:
- When the power up sequence is complete, the blood pump display will be
alternating between these two displays:
Note: If the above display has a number 2 instead of a number 1, press the
[] down key on the blood pump control panel to change it to 1.
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From the Calibrate Sensors screen, select1 the Arterial Pressure screen button.
The screen will change to the following:
Select1 the Arterial Blood Pump screen button and the screen will change to the
following:
Note: Depending on the HARDWARE OPTION set for the ART PUMP
option, the display may read POSTPUMP instead of PREPUMP. The
bargraph scale will also be different (500 to –80mmHg).
1
Refer to Section 1.3 on the use of screen buttons.
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1. Open arterial transducer port PART. on the blood pump module to air
(atmospheric pressure).
Note: Use the Arterial Level Adjust [] key on the blood pump control
panel to abort the calibration process without changing the stored DAC
value on the blood pump.
Press the [Start/Stop] key on the blood pump and its display will change to
the following:
Press the [Start/Stop] key again and the small zero will start to flash.
2. Use the [] and [] keys on the blood pump to adjust the Arterial
Pressure data box on the 2008K2 display to indicate 0 mmHg.
Press the [CONFIRM] key and the 2008K2 display will change.
Press the [Start/Stop] key on the blood pump and its display will change
back to the following alternating display:
Press the [Start/Stop] key again and the display will change to the
following:
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Press the [] key on the blood pump to change it to the following:
Press the [Start/Stop] key and the small zero will start to flash.
3. Attach a syringe and a calibrated pressure gauge to the PART port using a
T- fitting.
Use the [] and [] keys on the blood pump to adjust the Arterial
Pressure data box on the 2008K2 display to indicate 200mmHg.
Press the [CONFIRM] key and the 2008K2 display will change.
Press the [Start/Stop] key on the blood pump and its display will
change back to the alternating display:
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6. Pressurize the PART port by either pushing or pulling on the syringe.
7. Verify that the Arterial Pressure and Pressure at Actuator Board meter
boxes can reach at least 290mmHg (510mmHg for postpump) and that they
are within 10mmHg of each other.
8. Press the [CONFIRM] key to save the data. The screen will change.
Caution: The following step must be performed on the blood pump or the
calibration data you just collected and tested will be lost when the machine
is turned off.
Press the [] and [] keys on the blood pump at the same time to save the
DAC values to the blood pump memory. While pressing both keys, the
blood pump display will show dashes as shown below:
Press the [CONFIRM] key to complete the calibration and return to the
Calibrate Sensors screen.
Power the machine OFF and move the blood pump Service Jumper into the
Not in Service Mode position (see Figure 5).
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2.2.2 VENOUS PRESSURE CALIBRATION
From the Calibrate Sensors screen, select1 the Venous Pressure screen
button. The screen will change to the following:
1. Open the venous transducer port PVEN. on the level detector module to air
(atmospheric pressure).
2. Adjust the ZERO SET potentiometer (see Figure 6) so that the Venous
Pressure data box indicates zero mmHg.
3. Attach a syringe and a calibrated pressure gauge to the PVEN. port using a
T- fitting.
1
Refer to Section 1.3 on the use of screen buttons.
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400 MMHG SET
(P4)
ZERO SET
(P3)
LP450
(Type 1)
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4. Push the syringe plunger in to show a pressure of 400mmHg on the external
pressure gauge.
7. Verify that the Venous Pressure and Pressure at Actuator Board meter
boxes can reach at least 510mmHg and that they are within 10mmHg of each
other.
Verify that the Venous Pressure and Pressure at Actuator Board meter
boxes can reach at least –90mmHg and that they are within 10mmHg of each
other.
8. Press the [CONFIRM] key to save the calibration. The screen will change.
Press the [CONFIRM] key again to complete the calibration and return to
the Calibrate Sensors screen.
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2.2.3 DIALYSATE PRESSURE CALIBRATION
1. Hang a four-way connector on the I.V. pole at the normal dialyzer height.
Remove the dialyzer lines from the shunt and attach them to the connector.
Note: The four-way connector is included in the Fresenius Test Kit part
number 150034.
Connect a 30cc syringe to one of the four-way connector outlets and clamp
the tubing.
Note: If there is no dialysate flow through the flow indicator, make sure
the yellow Dialysate Flow on/off light is off and the shunt door is closed.
Wait approximately one minute after the flow has been verified to ensure
NO AIR is present at the dialysate pressure transducer #9 in the hydraulic
flow path. Press the [CONFIRM] key and the screen will change.
1
Refer to Section 1.3 on the use of screen buttons.
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3. Press the [Dialysate Flow on/off] key to stop dialysate flow.
Unclamp the lines leading to the 30cc syringe and the pressure gauge.
5. While holding this pressure, press the [CONFIRM] key. The screen will
change.
7. While holding this pressure, press the [CONFIRM] key to save the data.
The screen will change.
8. Open the shunt and remove the lines from the external pressure gauge.
Replace them on the shunt and close the door.
Press the [CONFIRM] key to complete the calibration and return to the
Calibrate Sensors screen.
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2.2.4 TEMPERATURE SENSOR CALIBRATION
Perform the temperature sensor calibration as follows using the test connector set
referenced in Section 1.1. The display screen calls for connecting specific
resistances to the X3 (MON-NTC) connector position on the distribution panel
(See Figure 1, pg. 5) for each test. The test connectors contain resistors which are
the closest 1% tolerance resistor available to these values. In the following
procedure, each test connector is identified by the number marked on its cover.
From the Calibrate Sensors screen, select1 the Temp Sensor screen button.
The screen will change to the following:
1. Remove the distribution board cover from the back of the machine.
Press the [CONFIRM] key to save the data. The screen will change.
Press the [CONFIRM] key to save the data. The screen will change.
1
Refer to Section 1.3 on the use of screen buttons.
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3. Remove the previous test connector and connect test connector 80
(1.255K) into X3 (MON-NTC) connection on the distribution board.
Press the [CONFIRM] key to save the data. The screen will change.
Press the [CONFIRM] key to complete the calibration and return to the
Calibrate Sensors screen.
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2.2.5 POST TEMPERATURE SENSOR CALIBRATION
Perform the post temperature sensor calibration as follows using the test
connector set referenced in Section 1.1. The display screen calls for connecting
specific resistances to the X44 (NTC-POST) connector position on the
distribution panel (See Figure 1, pg. 5) for each test. The test connectors contain
resistors which are the closest 1% tolerance resistor available to these values. In
the following procedure, each test connector is identified by the number marked
on its cover.
From the Calibrate Sensors screen, select1 the Post Temp Sensor screen
button. The screen will change to the following:
1. Remove the distribution board cover from the back of the machine.
Press the [CONFIRM] key to save the data. The screen will change.
1
Refer to Section 1.3 on the use of screen buttons.
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2. Remove the previous test connector and connect test connector 41
(5.117K) into X44 (NTC-POST) connection on the distribution board.
Press the [CONFIRM] key to complete the calibration and return to the
Calibrate Sensors screen.
Remove the test connector and replace the X44 (NTC-POST) connector
on the distribution board.
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2.2.6 TEMPERATURE CONTROL CALIBRATION
The Temperature Control Calibration is dependent upon enabled options.
Perform the appropriate calibration according to the list below:
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2.2.6.1 TEMPERATURE CONTROL CALIBRATION (METHOD 1)
Perform this section only if the machine is equipped with the following:
- The machine does not have the OLC option installed OR OLC option is
installed but the Temp Comp option is disabled and the slow flow option is
disabled.
Replace any panels that have been removed so that the machine is closed up as it
would be in normal operation. It is important for this calibration that ventilation
around the hydraulics unit be the same as it is when the machine is used for
dialysis.
From the Calibrate Sensors screen, select1 the Temp Control screen button.
The screen will change to the following:
1
Refer to Section 1.3 on the use of screen buttons.
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1. Verify in the Selected Concentrate box that the type of concentrate used
is selected.
Note: If the Change Type button is selected1, the Enter Conc screen
will be displayed. Change the selected concentrate and then select1
Calibrate Sensors screen key and then Temp Control screen button to
return to step 1 above.
2. Press the [CONFIRM] key to start the calibration. The screen will change.
4. Remove the dialysate lines from the shunt and connect them to an external
temperature meter. Close the shunt door.
Adjust the TEMP DAC value, then press the [CONFIRM] key.
Note: The TEMP DAC value does not take effect until the [CONFIRM]
key is pressed and the TEMP DAC data button is light yellow.
1
Refer to Section 1.3 on the use of screen buttons.
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The temperature of the dialysate shown on the external meter will change
after a delay. Find a TEMP DAC value that produces a temperature on the
external meter of 37°C.
Wait five minutes after the last adjustment of the TEMP DAC value, then
verify that the temperature on the external meter has remained at 37°C. If
not, change the TEMP DAC value, and wait five minutes again.
7. When the temperature remains at 37°C, press the [CONFIRM] key. The
screen will change.
Adjust the value shown for Monitor Reference until it matches the
external temperature meter at 37°C and then press the [CONFIRM] key.
9. Press the [CONFIRM] key again to save the data. The screen will change.
Open the shunt to stop the dialysate flow, remove the lines from the
external meter and replace them on the shunt.
Press the [CONFIRM] key to complete the calibration and return to the
Calibrate Sensors screen.
1
Refer to Section 1.3 on the use of screen buttons.
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2.2.6.2 TEMPERATURE CONTROL CALIBRATION (METHOD 2)
Perform this section only if the machine is equipped with the following:
- The machine does not have the OLC option installed OR OLC option is
installed but the Temp Comp option is disabled and the slow flow option is
enabled.
If the slow flow option is enabled, the Temp Control calibration is done in two
parts. The DAC and temperature monitor calibration is performed at 500ml/min
flow rate and then it is calibrated at a 100ml/min flow rate.
Replace any panels that have been removed so that the machine is closed up as it
would be in normal operation. It is important for this calibration that ventilation
around the hydraulics unit be the same as it is when the machine is used for
dialysis.
From the Calibrate Sensors screen, select1 the Temp Control screen button.
The screen will change to the following:
1
Refer to Section 1.3 on the use of screen buttons.
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1. Verify in the Selected Concentrate box that the type of concentrate used
is selected.
Note: If the Change Type button is selected1, the Enter Conc screen
will be displayed. Change the selected concentrate and then select1
Calibrate Sensors screen key and then Temp Control screen button to
return to step 1 above.
2. Press the [CONFIRM] key to start the calibration. The screen will change.
4. Remove the dialysate lines from the shunt and connect them to an external
temperature meter. Close the shunt door.
Adjust the TEMP DAC value, then press the [CONFIRM] key.
Note: The TEMP DAC value does not take effect until the [CONFIRM]
key is pressed and the TEMP DAC data button is light yellow.
1
Refer to Section 1.3 on the use of screen buttons.
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The temperature of the dialysate shown on the external meter will change
after a delay. Find a TEMP DAC value that produces a temperature on the
external meter of 37°C.
Wait five minutes after the last adjustment of the TEMP DAC value, then
verify that the temperature on the external meter has remained at 37°C. If
not, change the TEMP DAC value, and wait five minutes again.
7. When the temperature remains at 37°C, press the [CONFIRM] key. The
screen will change.
Adjust the value shown for Monitor Reference until it matches the external
temperature meter at 37°C and then press the [CONFIRM] key.
9. Press the [CONFIRM] key again and the screen will change.
10. The Temp Control calibration now changes the flow to 100ml/min.
Press the [CONFIRM] key and then select the TEMP DAC data button.
Adjust the TEMP DAC value, then press the [CONFIRM] key.
Note: The TEMP DAC value does not take effect until the [CONFIRM]
key is pressed and the TEMP DAC data button is light yellow.
The temperature of the dialysate shown on the external meter will change
after a delay. Find a TEMP DAC value that produces a temperature on the
external meter of 37°C. Be patient, the 100ml/min flow rate calibration
takes time.
1
Refer to Section 1.3 on the use of screen buttons.
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Wait five minutes after the last adjustment of the TEMP DAC value, and
then verify that the temperature on the external meter has remained at 37°C.
If not, change the TEMP DAC value, and wait five minutes again.
11. When the temperature remains at 37°C, press the [CONFIRM] key. The
screen will change.
Adjust the value shown for Monitor Reference until it matches the
external temperature meter at 37°C and then press the [CONFIRM] key.
13. Press the [CONFIRM] key again to save the data. The screen will change.
Open the shunt to stop the dialysate flow, remove the lines from the
external meter and replace them on the shunt.
Press the [CONFIRM] key to complete the calibration and return to the
Calibrate Sensors screen.
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2.2.6.3 TEMPERATURE CONTROL CALIBRATION (METHOD 3)
Perform this section only if the machine is equipped with the following:
- The machine has the OLC option installed AND the Temp Comp option is
enabled and the slow flow option is disabled.
Note: The Temp Comp option uses post temperature sensor NTC44. Do not
attempt to calibrate a non-OLC machine with the Temp Comp option enabled
since NTC44 is not present and an Operator Error will occur.
Replace any panels that have been removed so that the machine is closed up as it
would be in normal operation. It is important for this calibration that ventilation
around the hydraulics unit be the same as it is when the machine is used for
dialysis.
From the Calibrate Sensors screen, select1 the Temp Control screen button.
The screen will change to the following:
1
Refer to Section 1.3 on the use of screen buttons.
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1. Verify in the Selected Concentrate box that the type of concentrated
used is selected.
Note: If the Change Type button is selected1, the Enter Conc screen
will be displayed. Change the selected concentrate and then select1
Calibrate Sensors screen key and then Temp Control screen button to
return to step 1 above.
2. Press the [CONFIRM] key to start the calibration. The screen will change.
3. Remove the dialysate lines from the shunt and connect them to an external
temperature meter. Close the shunt door.
The machine will run at a 500ml/min flow rate to bring up conductivity and
temperature. When the temperature becomes stable, the Stability counter
will start to count up. As soon as it is greater than 70 a 2-minute Timer
starts to count down. During this time the Stability counter will continue to
increase to 100 and stay at 100 for the remaining 2-minutes. Once the
2-minutes Timer reaches zero, the screen will change.
Note: If the Stability counter drops below 70 during the 2-minute Timer,
the 2-minutes will be reset and will wait for the Stability counter to be
greater than 70 again.
1
Refer to Section 1.3 on the use of screen buttons.
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6. Select1 the Monitor Reference data button.
Adjust the value shown for Monitor Reference until it matches the
external temperature and then press the [CONFIRM] key and the screen
will change.
7. Press the [CONFIRM] key again and the screen will display Please wait,
getting stable temperature.
The machine now runs in bypass at a 500ml/min flow rate for 2-minutes.
Once the 2-minute Timer has reached zero, a 6-minute Timer is set. The
machine continues to run in bypass and at a 500ml/min flow rate and
depending on the stability, the 6-minute Timer may start to count down. It
is normal for the Stability counter to decrease during this time. If the
Stability counter becomes less than 70, the Timer will be reset to 6-
minutes and will wait for the Stability counter to be greater than 70 again.
Once the 6-minute Timer reaches zero, the screen will change.
8. Press the [CONFIRM] key to save the data. The screen will change.
Open the shunt to stop the dialysate flow, remove the lines from the
external meter and replace them on the shunt.
Press the [CONFIRM] key to complete the calibration and return to the
Calibrate Sensors screen.
1
Refer to Section 1.3 on the use of screen buttons.
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2.2.6.4 TEMPERATURE CONTROL CALIBRATION (METHOD 4)
Perform this section only if the machine is equipped with the following:
- The machine has the OLC option installed AND the Temp Comp option is
enabled and the slow flow option is enabled.
Note: The Temp Comp option uses post temperature sensor NTC44. Do not
attempt to calibrate a non-OLC machine with the Temp Comp option enabled
since NTC44 is not present and an Operator Error will occur.
If the slow flow option is enabled, the Temp Control calibration is done in two
parts. The DAC and temperature monitor calibration is performed at 500ml/min
flow rate and then it is calibrated at a 100ml/min flow rate.
Replace any panels that have been removed so that the machine is closed up as it
would be in normal operation. It is important for this calibration that ventilation
around the hydraulics unit be the same as it is when the machine is used for dialysis.
From the Calibrate Sensors screen, select1 the Temp Control screen button.
The screen will change to the following:
1
Refer to Section 1.3 on the use of screen buttons.
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1. Verify in the Selected Concentrate box that the type of concentrate used
is selected.
Note: If the Change Type button is selected1, the Enter Conc screen
will be displayed. Change the selected concentrate and then select1
Calibrate Sensors screen key and then Temp Control screen button to
return to step 1 above.
2. Press the [CONFIRM] key to start the calibration. The screen will change.
3. Remove the dialysate lines from the shunt and connect them to an external
temperature meter. Close the shunt door.
The machine will run at a 500ml/min flow rate to bring up conductivity and
temperature. When the temperature becomes stable, the Stability counter
will start to count up. As soon as it is greater than 70 a 2-minute Timer
starts to count down. During this time the Stability counter will continue to
increase to 100 and stay at 100 for the remaining 2-minutes. Once the
2-minutes counter reaches zero, the screen will change.
Note: If the Stability counter drops below 70 during the 2-minute Timer,
the 2 minutes will be reset and will wait for the Stability counter to be
greater than 70 again.
1
Refer to Section 1.3 on the use of screen buttons.
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6. Select1 the Monitor Reference data button.
Adjust the value shown for Monitor Reference until it matches the external
temperature and then press the [CONFIRM] key and the screen will change.
7. Press the [CONFIRM] key again and the screen will display Please wait,
getting stable temperature.
The machine now runs in bypass at a 500ml/min flow rate for 2-minutes.
Once the 2-minute Timer has reached zero, a 6-minute Timer is set. The
machine continues to run in bypass and at a 500ml/min flow rate and
depending on the stability, the 6-minute Timer may start to count down. It
is normal for the Stability counter to decrease during this time. If the
Stability counter becomes less than 70, the Timer will be reset to 6-minutes
and will wait for the Stability counter to be greater than 70 again.
Once the 6-minute counter reaches zero, a 10-minute Timer is set. The
machine comes out of bypass and changes to a 100ml/min flow rate. When
the temperature becomes stable, the Stability counter will start to count up.
As soon as it is greater than 70 the 10-minute Timer starts to count down.
During this time the Stability counter will continue to increase to 100 and
stay at 100 for the remaining 10-minutes. Once the 10-minutes Timer
reaches zero, the screen will change.
Note: If the Stability counter drops below 70 during the 10-minute Timer
starts, the 10-minutes will be reset and will wait for the Stability counter to
be greater than 70 again.
Adjust the value shown for Monitor Reference until it matches the external
temperature and then press the [CONFIRM] key and the screen will change.
9. Press the [CONFIRM] key again to save the data. The screen will change.
Open the shunt to stop the dialysate flow, remove the lines from the
external meter and replace them on the shunt.
Press the [CONFIRM] key to complete the calibration and return to the
Calibrate Sensors screen.
1
Refer to Section 1.3 on the use of screen buttons.
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2.2.7 BLOOD LEAK CALIBRATION
The glass tube in the blood leak detector must be clean before the blood leak
detector calibration can be completed successfully. The glass tube in the detector
is cleaned by performing a bleach rinse, which washes the tube out along with the
rest of the hydraulics.
There are two calibrations performed on the Blood Leak Detector. One calibrates
the detector itself and the other calibrates the dimness circuits. Perform the
procedures as described below.
From the Calibrate Sensors screen, select1 the Blood Leak Detector screen
button. The screen will change to the following:
1. Verify that the machine has received a bleach rinse recently, or perform a
bleach rinse as described in the Operator’s Manual before calibrating the
blood leak detector.
2. Press the [CONFIRM] key. The screen will change and the blood leak
calibration will start.
1
Refer to Section 1.3 on the use of screen buttons.
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3. The first calibration that is performed is the automatic blood leak
calibration. When it’s finished, the screen will change.
5. Press the [CONFIRM] key to save the data. The screen will change.
Press the [CONFIRM] key again to complete the calibration and return to
the Calibrate Sensors screen.
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2.2.8 CONDUCTIVITY CELLS CALIBRATION
Machines equipped with Online Clearance (OLC) have two conductivity cells.
The first conductivity cell is PRE dialyzer and the second conductivity cell is
POST dialyzer.
From the Calibrate Sensors screen, select1 the Cond Cells screen button. The
screen will change to the following:
1. Identify the concentrate you will be using to calibrate the conductivity cells.
Select the concentrate by selecting1 the Conc button. The screen will
change showing a list of concentrates. Use the [] and [▬] keys to scroll
through the list to locate your concentrate.
Note: In order to select your concentrate from the list, it must have been
previously entered in the Enter Conc screen. This screen can be found by
selecting1 the OPTIONS screen button.
1
Refer to Section 1.3 on the use of screen buttons.
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Press the [CONFIRM] key to select your concentrate and the screen will
return to the CALIBRATE CONDUCTIVITY CELL(S) screen.
3. Remove the dialysate lines from the shunt and connect them to an external
conductivity meter. Close the shunt door.
Note: If using the Automata Neo-1 meter, attach the ground strap per the
manufacturer’s instructions.
Press the [CONFIRM] key to start the calibration. The screen will change.
4. Wait until the conductivity value is stable. When conductivity is stable, the
screen will change.
5. Once the conductivity is stable and the screen has changed, select1 the
Conductivity data button.
Adjust the value shown for Conductivity until it matches the reading on the
external conductivity meter and then press the [CONFIRM] key.
6. Press the [CONFIRM] key again and the screen will change.
7. Open the shunt door and remove the external conductivity meter from the
dialysate line.
Connect the dialysate lines to a large dialyzer with the blood side filled.
8. The screen will change and the machine is now adjusting to its first
reference point of conductivity for the post conductivity cell. When the
reference conductivity is stable, the screen will change.
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10. The machine is now adjusting to a third reference point of conductivity for
the post conductivity cell. When the conductivity is stable again, the screen
will change.
11. The machine is now adjusting to a fourth reference point of conductivity for
the post conductivity cell. When the conductivity is stable again, the screen
will change.
Press the [CONFIRM] key to save the data. The screen will change.
Disconnect the dialyzer and replace the dialysate lines in the shunt.
Press the [CONFIRM] key to complete the calibration and return to the
Calibrate Sensors screen.
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2.3 MONITOR CALIBRATION PROCEDURES
From the Service Mode screen, select1 the Calibrate Monitor screen button.
The following screen will appear showing the four monitor calibrations:
Set Clock
Voltage Detection
1
Refer to Section 1.3 on the use of screen buttons.
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2.3.1 SET CLOCK
From the Calibrate Monitor screen, select1 the Set Clock screen button. The
screen will change to the following:
When all of the data has been entered, press the [CONFIRM] key to return
to the Calibrate Monitor screen.
1
Refer to Section 1.3 on the use of screen buttons.
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2.3.2 VOLTAGE DETECTION CALIBRATION
From the Calibrate Monitor screen, select1 the Voltage Detection screen button.
The screen will change to the following:
1. Open the monitor unit and connect a Digital Voltmeter between the
+12 volt test and the ground test points shown in Figure 7.
Set the 12 volt set value to the voltage shown on the digital voltmeter, then
press the [CONFIRM] key.
3. Press the [CONFIRM] key again and the screen will change.
1
Refer to Section 1.3 on the use of screen buttons.
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+12 VOLT
TEST POINT
ON JUMPER 1
SENSOR BOARD
P/N 190193-02
PIN 2 OR 3 ON P15
FOR GROUND
FUNCTIONAL BOARD
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The screen will display:
4. Verify that the 5V EST. displayed on the screen is between 4.8 and
5.2 volts.
5. Verify that the 12V EST. displayed on the screen is between 11.7 and
12.3 volts.
Note: If the values are not within limits, repeat the Voltage Detection
calibration.
6. If the values are within limits, press the [CONFIRM] key to save the data.
The screen will change.
Press the [CONFIRM] key to complete the calibration and return to the
Calibrate Monitor screen.
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2.3.3 ARTERIAL PUMP RATE
From the Calibrate Monitor screen, select1 the Art Pump Rate screen button.
The screen will change to the following:
Press the [CONFIRM] key to save the data. The screen will change.
3. Press the [CONFIRM] key again to complete the calibration and return to
the Calibrate Monitor screen.
1
Refer to Section 1.3 on the use of screen buttons.
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2.3.4 VENOUS PUMP RATE
From the Calibrate Monitor screen, select1 the Ven Pump Rate screen button.
The screen will change to the following:
Press the [CONFIRM] key to save the data. The screen will change.
3. Press the [CONFIRM] key again to complete the calibration and return to
the Calibrate Monitor screen.
1
Refer to Section 1.3 on the use of screen buttons.
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3.0 CALIBRATION PROCEDURES NOT PERFORMED IN SERVICE MODE
The following procedures are performed with the machine in normal (not Service
mode) operation (see Section 1.2).
3. Insert a pressure gauge in the water line at the outlet of water inlet pressure
regulator #61 (See Figure 1, pg. 5).
Caution: Use tie wraps or tubing clamps to secure the connections. The water
pressure may be sufficient to blow the lines off of the gauge if they are not
secured.
6. With the dialysate lines in the shunt, select Dialysis mode and start the
dialysate flow. The pressure gauge will cycle between two readings as
water inlet valve opens and closes.
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7. On regulator #61, loosen the lock nut around the adjustment screw (See
Figure 1, pg. 5). Use a 5mm Allen wrench to adjust the regulator for a peak
pressure of between 18 and 20 psi when water inlet valve 41 is closed.
Note: The gauge must indicate a minimum pressure greater than 8 psi
when valve 41 is open. If not, the treated water supply may not meet
specifications for flow and pressure.
8. Tighten the lock nut and verify the peak pressure is still between 18 and 20 psi
on the gauge.
9. Turn the machine Off, turn off the source water supply, remove the gauge
and reconnect the tubing using clamps to prevent leaks.
10. Turn the treated water supply source On, turn the machine On and select1
Dialysis mode. Start dialysate flow and inspect all hoses and connections
for leaks.
1
Refer to Section 1.3 on the use of screen buttons.
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3.2 LEVEL DETECTOR CALIBRATION
1. Place the machine in Dialysis mode and clear all blood alarms.
2. Insert a venous chamber filled with warm water into the level detector.
4. Observe the Channel 1 LED (see Figure 8). If the LED is On, turn channel
1 potentiometer (see Figure 8) clockwise until the LED turns off.
7. Move the jumper back to the Normal position (see Figure 8).
8. Press the [RESET] key to clear the alarm and check that both LED’s are
off, indicating that the Level Detector is sensing no air present in the
venous chamber.
9. Remove the venous chamber and watch the LED’s. Verify that channel 1
lights first followed quickly by channel 2.
Note: Channel 1 stops the blood pump and Channel 2 clamps the venous
blood line.
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R19
Note: The type of CHANNEL 1
potentiometer may vary
in shape and size. R20
CHANNEL 2
CHANNEL 1 LED
LIGHTS FIRST
CHANNEL 2 LED
LIGHTS SECOND
JUMPER POSITIONS
NORMAL
CALIBRATE
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3.3 BLOOD PUMP CALIBRATION
The speed control circuit on a 2008K2 blood pump consists of a feedback circuit
that monitors the motor speed and automatically adjusts to compensate for any
speed fluctuations. There are no adjustments or calibrations on this circuit.
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COMMON CONVERSIONS
PRESSURE
VOLUME
MASS
Manufactured by:
Fresenius USA, Inc.
2637 Shadelands Drive
Walnut Creek, CA 94598 http://www.fmcna.com
800 227-2572