Fresenius Medical Care DIASAFE 2008 K Use and care manual

2
5
87
1
4
9 0
3
6
FRESENIUS 2008K
HEMODIALYSIS SYSTEM
CALIBRATION
PROCEDURES
Part Number 507296 Rev. D

FRESENIUS MEDICAL CARE
NORTH AMERICA
800-227-2572 or 925-295-0200
Fresenius Medical Care North America
920 Winter St.
Waltham, MA 02451
Manufactured by:
Fresenius USA, Inc.
2637 Shadelands Drive
Walnut Creek, CA 94598
REGIONAL EQUIPMENT SPECIALIST: __________________________________

FRESENIUS 2008K
HEMODIALYSIS SYSTEM
CALIBRATION
PROCEDURES
Part Number 507296 Rev D
http://www.fmcna.com
Copyright 2000 - 2012 Fresenius Medical Care North America, All Rights Reserved

Page ii Fresenius 2008®K Calibration Procedures
P/N 507296 Rev D
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.

Page iii
Fresenius 2008®K Calibration Procedures
P/N 507296 Rev D
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..................................................................................................15
2.2.3 BALANCE CHAMBER VOLUME CALIBRATION..............................................................................16
2.2.4 ACID (CONCENTRATE) PUMP VOLUME CALIBRATION...............................................................18
2.2.5 BICARBONATE PUMP VOLUME CALIBRATION............................................................................20
2.2.6 UF PUMP VOLUME CALIBRATION.................................................................................................22
2.3 SENSOR CALIBRATION PROCEDURES .................................................................................25
2.3.1 ARTERIAL PRESSURE CALIBRATION...........................................................................................26
2.3.2 VENOUS PRESSURE CALIBRATION .............................................................................................32
2.3.3 DIALYSATE PRESSURE CALIBRATION.........................................................................................35
2.3.4 TEMPERATURE SENSOR CALIBRATION...................................................................................... 37
2.3.5 POST TEMPERATURE SENSOR CALIBRATION............................................................................39
2.3.6 TEMPERATURE CONTROL CALIBRATION....................................................................................41
2.3.6.1 TEMPERATURE CONTROL CALIBRATION (METHOD 1)....................................................42
2.3.6.2 TEMPERATURE CONTROL CALIBRATION (METHOD 2)....................................................45
2.3.6.3 TEMPERATURE CONTROL CALIBRATION (METHOD 3)....................................................49
2.3.6.4 TEMPERATURE CONTROL CALIBRATION (METHOD 4).................................................... 52
2.3.7 BLOOD LEAK CALIBRATION ..........................................................................................................55
2.3.8 CONDUCTIVITY CELLS CALIBRATION..........................................................................................57
2.3.8.1 CONDUCTIVITY CELLS CALIBRATION (v2.16 or less)........................................................57
2.3.8.2 CONDUCTIVITY CELLS CALIBRATION (v2.25 or greater)...................................................59
2.4 MONITOR CALIBRATION PROCEDURES...............................................................................62
2.4.1 SET CLOCK......................................................................................................................................63
2.4.2 VOLTAGE DETECTION CALIBRATION...........................................................................................64
2.4.3 ARTERIAL PUMP RATE................................................................................................................... 67
2.4.4 VENOUS PUMP RATE.....................................................................................................................68
3.0 CALIBRATION PROCEDURES NOT PERFORMED IN SERVICE MODE ................. 69
3.1 INLET WATER PRESSURE REGULATOR CALIBRATION......................................................69
3.2 LEVEL DETECTOR CALIBRATION ..........................................................................................71
3.3 BLOOD PUMP CALIBRATION ..................................................................................................73

Page iv Fresenius 2008®K Calibration Procedures
P/N 507296 Rev D
NOTE
This document is written for Fresenius 2008K
Hemodialysis Systems using software versions
2.16 or later.

Page 1
Fresenius 2008®K Calibration Procedures
P/N 507296 Rev D
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.


Page 2 Fresenius 2008®K Calibration Procedures
P/N 507296 Rev D
1.1 TEST EQUIPMENT NEEDED
The following supplies and test equipment are required to perform the calibration
procedures.
Warning! Test equipment 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.
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.
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.


Page 3
Fresenius 2008®K Calibration Procedures
P/N 507296 Rev D
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.

Page 4 Fresenius 2008®K Calibration Procedures
P/N 507296 Rev D
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. 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.
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.



Page 5
Fresenius 2008®K Calibration Procedures
P/N 507296 Rev D
Figure 1 - 2008K Rear View
DEAERATION
(DEGAS) PUMP
CONNECTOR
#20
MON-NTC
CONNECTOR
#3
FLOW PUMP
OUTLET
UF PUMP
ADJUSTMENT
FLOW PUMP
BYPASS
VALVE
BLOOD PRESSURE
MODULE
INLET REGULATOR (61)
DRAIN PORT
PRESSURE
RELIEF VALVE (78)
RELIEF VALVE (65)
DEAERATION PUMP
BYPASS VALVE
DEAERATION
PUMP INLET
NTC-POST
CONNECTOR
#44

Page 6 Fresenius 2008®K Calibration Procedures
P/N 507296 Rev D
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:
Figure 2 - 2008K Front 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.
Control Panel
Touch Screen

Page 7
Fresenius 2008®K Calibration Procedures
P/N 507296 Rev D
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.

Page 8 Fresenius 2008®K Calibration Procedures
P/N 507296 Rev D
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.
Figure 3 - Meniscus Curve
BOTTOM OF
THE MENISCUS
CURVE
100
mL
90
80

Page 9
Fresenius 2008®K Calibration Procedures
P/N 507296 Rev D
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 & Loading Pressure
Sec. 2.2.1
- Deaeration Motor (or rebuild)
- Loading Pressure Relief Valve
- Flow Pump Head
- Flow Pressure
Sec. 2.2.2
- 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
- Temperature Control
Sec. 2.3.6
- 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
- Actuator or Actuator/Test Combo Board
- Voltage Detection
Sec. 2.4.2
- Sensor Board
- Arterial Pressure
Sec. 2.3.1
- Venous Pressure
Sec. 2.3.2
- Dialysate Pressure
Sec. 2.3.3
- Temperature Sensor
Sec. 2.3.4
- Post Temperature Sensor
Sec. 2.3.5
- 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
- Blood Pump Module
- Arterial Pressure
Sec. 2.3.1
- Arterial Pump Rate
Sec. 2.4.3
- Level Detector Module
- Venous Pressure
Sec. 2.3.2
- Level Detector
Sec. 3.2
Table 1 - Calibrate if Replaced

Page 10 Fresenius 2008®K Calibration Procedures
P/N 507296 Rev D
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.
-Touch the dot on the screen. Another dot will appear in a different spot on the
screen. There are a total of three dots that will appear. Touch each asterisk as
they appear. When the calibration is complete, the screen will prompt you to
power the machine off.


Page 11
Fresenius 2008®K Calibration Procedures
P/N 507296 Rev D
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:
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

Page 12 Fresenius 2008®K Calibration Procedures
P/N 507296 Rev D
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.


Page 13
Fresenius 2008®K Calibration Procedures
P/N 507296 Rev D
4. Select the PUMP RATE data button.
5. Adjust the PUMP RATE value to achieve a pressure reading of -24inHg
on the gauge attached to the deaeration pump (see elevation note below).
The gauge needle will be wiggling/vibrating slightly. Adjust the
pressure so the maximum value is -24inHg and verify that the needle
does not go below -25inHg.
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:
Elevation
Approx.
atmospheric
pressure
Minimum target deaeration
pressure relative to
atmospheric pressure
feet
mmHg
inches of Hg
0
760
-24.0
1000
728
-23.0
2000
697
-22.0
3000
667
-21.0
4000
639
-20.0
5000
612
-19.0
6000
585
-18.5
7000
561
-17.5
8000
537
-16.9
9000
514
-16.2
10000
492
-15.5



Page 14 Fresenius 2008®K Calibration Procedures
P/N 507296 Rev D
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filter system is installed, adjust pressure relief
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.
Press the [CONFIRM] key to complete the calibration and return to the
Calibrate Hydraulics screen.
Remove the gauges.
