Fresenius Medical Care 2008K2 User manual

Part Number 508138 Rev. J
2008K2
HEMODIALYSIS
SYSTEM
PREVENTIVE
MAINTENANCE
PROCEDURES

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2008K2Preventive Maintenance Procedures
P/N 508138 Rev. J
FRESENIUS MEDICAL CARE
NORTH AMERICA
800-227-2572
Fresenius Medical Care North America
920 Winter St.
Waltham, MA 02451
Manufactured by:
Fresenius USA, Inc.
4040 Nelson Avenue
Concord, CA 94520

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2008K2Preventive Maintenance Procedures
P/N 508138 Rev. J
2008K2
HEMODIALYSIS SYSTEM
PREVENTIVE MAINTENANCE
PROCEDURES
Part Number 508138 Rev. J
INCLUDING
PREVENTIVE MAINTENANCE CHECKLISTS
SIX (6) MONTH AND ANNUAL/4000 HOUR
http://www.fmcna.com
Copyright 2008 - 2017 Fresenius Medical Care, All Rights Reserved

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2008K2Preventive Maintenance Procedures
P/N 508138 Rev. J
2008K2Preventive Maintenance Procedures
This document contains proprietary information of Fresenius USA, Inc. d/b/a Fresenius
Medical Care North America and its affiliates (“Fresenius Medical Care”). The contents of
this document may not be disclosed to third parties, copied, or duplicated in any form, in
whole or in part, without the prior written permission of Fresenius Medical Care.
Fresenius Medical Care, the triangle logo, 2008 and DIASAFE are trademarks of Fresenius
Medical Care Holdings, Inc., or its affiliated companies. All other trademarks are the
property of their respective owners.
Caution: US Federal law restricts this device to sale only by or on the order of a physician.
Frequency, duration, and parameters of treatment are to be determined by the prescribing
physician.
Installation, maintenance, calibration and other technical information may be found in the
2008K2Technician’s Manual, P/N 490137.
Contact Fresenius Medical Care Technical Support for applicable Field Service Bulletins.
The spare parts manual for the model 2008K2and other information may be found on our
web site at www.fmcna.com
Indications for Use: The 2008K2hemodialysis machine is indicated for acute and chronic
dialysis therapy.
Conventions
Symbol Description
Warning! A warning is a statement that identifies conditions or
actions that could result in personal injury or loss of life.
Warnings found in this manual outside of this section are
designated with the warning symbol.
Shock Hazard: A shock hazard warning refers to a risk of a
possibly severe electrical shock due to improper use or handling
of the equipment.
Caution: A caution is a statement that identifies conditions or
actions that could result in damage to the machine.
Note: Notes are advisory comments or recommendations
regarding practices or procedures.

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PREVENTIVE MAINTENANCE PROCEDURES
TABLE OF CONTENTS
1.0 INTRODUCTION ............................................................................................................................ 1
1.1 TEST EQUIPMENT AND SUPPLIES NEEDED..........................................................................1
1.2 OPERATING MODES ................................................................................................................3
1.3 FRONT PANEL CONTROLS......................................................................................................4
1.4 MEASURING FLUID VOLUMES................................................................................................7
2.0 SIX (6) MONTH PREVENTIVE MAINTENANCE........................................................................... 8
2.1 FILTERS...................................................................................................................................10
2.2 PRE-UF PUMP FILTER............................................................................................................10
2.3 UF PUMP CHECK VALVES .....................................................................................................11
2.4 HIGH VOLTAGE AC CONNECTIONS......................................................................................11
2.5 UF PUMP .................................................................................................................................12
2.6 CONDUCTIVITY ......................................................................................................................12
2.7 TEMPERATURE ......................................................................................................................13
2.8 ALARMOPERATION AND PRESSURE HOLDING TESTS.....................................................14
2.9 VERIFYPH...............................................................................................................................16
2.10 POWERFAILURE ALARM.......................................................................................................16
2.11 FINAL CHECKS .......................................................................................................................17
3.0 ANNUAL (4000 HOUR) PREVENTIVE MAINTENANCE............................................................18
3.1 FILTERS AND O-RINGS..........................................................................................................18
3.2 PRE-UF PUMP FILTER............................................................................................................19
3.3 UF PUMP CHECK VALVES .....................................................................................................19
3.4 DIAPHRAGM PUMPS ..............................................................................................................19
3.5 HEATERELEMENT.................................................................................................................20
3.6 HIGH VOLTAGE AC CONNECTIONS......................................................................................20
3.7 DEAERATION MOTOR BRUSHES..........................................................................................21
3.8 INLETWATERPRESSUREREGULATOR..............................................................................22
3.9 ONLINE CLEARANCE TEST (IF APPLICABLE).......................................................................23
3.10 DEAERATIONAND LOADING PRESSURE ............................................................................26
3.11 FLOW RELIEF PRESSURE.....................................................................................................27
3.12 CONCENTRATE AND BICARB PUMPS..................................................................................28
3.13 UF PUMP .................................................................................................................................28
3.14 CONDUCTIVITY ......................................................................................................................28
3.15 TEMPERATURE ......................................................................................................................28
3.16 VOLT HI LO DETECT...............................................................................................................28
3.17 BLOOD LEAK AND DIMNESS .................................................................................................29
3.18 ARTERIAL, VENOUS AND TRANSMEMBRANE PRESSURE.................................................30
3.19 DIALYSATE FLOW ..................................................................................................................33
3.20 HEPARINPUMP ......................................................................................................................33
3.21 BLOOD PUMP..........................................................................................................................36
3.22 LEVEL DETECTOR..................................................................................................................38
3.23 ALARMOPERATION AND PRESSUREHOLDING TESTS.....................................................40
3.24 VERIFY PH ..............................................................................................................................40
3.25 RINSE CHECKS.......................................................................................................................41
3.26 BATTERYAND POWER FAILURE ALARM .............................................................................42
3.27 BLOOD PRESSURE MODULE ................................................................................................43
3.28 FINALCHECKS .......................................................................................................................46
4.0 REBUILDING THE DIAPHRAGM PUMPS..................................................................................47
4.1 REBUILDING THE ULTRAFILTRATION PUMP.......................................................................47
4.2 REBUILDING THE CONCENTRATE AND BICARBONATE PUMPS .......................................50
4.3 TESTING CONCENTRATE AND BICARBONATE PUMPS......................................................52
PREVENTIVE MAINTENANCE CHECKLIST SIX (6) MONTH...........................................................55
PREVENTIVE MAINTENANCE CHECKLIST ANNUAL/4000 HOUR ................................................57

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General Warnings
Warning! 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.
Shock Hazard: Refer servicing to qualified personnel.
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
Warning! Only Original Equipment Manufacturer (OEM)
Fresenius Medical Care parts should be used in the repair or
upgrade of the Fresenius Medical Care 2008K2Hemodialysis
System. Although, parts may look similar to parts in various
vendor catalogs or brick and mortar stores the 2008K2
Hemodialysis System uses parts that have been specified and tested
in accordance to ANSI/AAMI/ISO guidelines. The use of non-
OEM parts will void your warranty and may cause patient harm.
Note: This document is written for the 2008K2Hemodialysis
Systems using software versions 5.28 or later.

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1.0 INTRODUCTION
Preventive Maintenance for the 2008K2Hemodialysis System is simple and
straightforward. Maintenance is performed in only two intervals: six (6) months, and
annually or after 4000 hours of operation. The maintenance procedures have been
devised to require a minimum of time while ensuring that the machine is maintained
in optimum operating condition.
Included in the Preventive Maintenance procedures are tests to verify normal machine
operation. Should the machine fail to pass any of these tests, repair or re-calibrate as
needed, then repeat the tests until the specifications are met before returning the
machine to service.
Checklists are provided in the back of this manual to record the work done. Make
copies of these checklists as needed. Your initials on the checklist certifies that each
procedure has been completed and that the machine is performing according to the
specifications given.
1.1 TEST EQUIPMENT AND SUPPLIES NEEDED
A number of small parts must be available to perform the Preventive Maintenance.
Part number 190098 is a kit of the parts needed, except for the 9-Volt battery that
must be replaced during the annual preventive maintenance. An NEDA 1604AC
heavy-duty (alkaline type) battery is required. In addition, the following test
equipment is needed:
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.
Warning! Disinfect the machine internally and externally and check all pressure transducer protectors for contamination before working on the
machine.

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•2008K2Calibrations Procedures (part number 508137).
•Test Kit (part number 150034), which contains two pressure gauges with
fittings and hoses for measuring loading pressure and deaeration pressure.
•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 from -250mmHg to +400mmHg with an accuracy of at least
±3mmHg. 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 0.1mS over a range of 12mS to
17mS at a temperature of 25°C.
•Stopwatch with a resolution to 0.01 second and an accuracy of 0.01% or better.
•Buret, 25ml capacity with 0.1ml graduations (part number 290104).
•Graduated cylinder: 1000ml capacity with a tolerance of 10.0ml at 1000ml or
better.
•Syringe, 60cc capacity. Tolerance is not important; the syringe is not used for
volume measurements.
•Tubing, 24” long (part number 545325-10). Use on the tip of the Buret.
•Resistor Plug Set for OLC Testing (part number 190168).
The following equipment is also required to test the blood pressure module:
•Dummy Cuff (part number 370090). The Dummy Cuff contains two air
chambers with calibrated volumes.
•Mercury manometer or equivalent pressure meter accurate to within 1mmHg at
pressures up to 330mmHg.

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1.2 OPERATING MODES
The following preventive maintenance procedures contain instructions to place the
2008K2into 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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1.3 FRONT PANEL CONTROLS
The front panel consists of many areas. The following illustrates these areas:
Figure 1 - 2008K2Front Panel
Control Panel Operation
Throughout the preventive maintenance 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.
Screen Keys
Control Panel
Data Entry Keys
Navigation Keys
Control Panel
LCD Screen

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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, 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.
Screen Button (screen key)
The bottom row of blue screen buttons are selected by pressing
the corresponding screen key directly below the screen button.
By pressing a screen key, the screen will change to the selected
screen directly without pressing the [CONFIRM] key. If data
entry, option change, or menu selection is in process when a
screen key is pressed, a message requiring the operator to press
the [Escape] key or the [CONFIRM] key is displayed instead
of changing screens.
Screen Button (screen change)
Some screen buttons that change screens are not part of the
bottom row of the display. To use this type of screen button it
must be highlighted first. Use the navigation keys ([▲],[▼],
[◄],and [►]) to highlight the desired screen button then press
the [CONFIRM] key. The screen will change.
A screen button is not active if it is gray.

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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.
If a screen change is required while a menu is being displayed, the operator is
prompted to press either the [Escape] key or the [CONFIRM] key.
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 2).
Measure the volume at the bottom of the meniscus curve as shown.
Figure 2. Meniscus Curve.
BOTTOM OF
MENISCUS
CURVE

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2.0 SIX (6) MONTH PREVENTIVE MAINTENANCE
Perform the following Preventive Maintenance procedures every six (6) months of
machine operation.
Make copies of the Six (6) Month Preventive Maintenance Checklist provided in
the back of this manual and use them to record the maintenance done.
Note: When performing an Annual Preventive Maintenance do not perform
the six (6) month procedures below first. Go directly to Section 3 and perform
the annual procedures described there.
While performing the following procedures, check the floor of the hydraulic unit and
all surfaces for moisture that might indicate a leak. Locate and correct any leaks
detected. Clean the floor of the hydraulic unit so that future leaks will be readily
apparent. Also, check all electrical connectors that can be reached to be sure they are
fully seated and there is no strain on the electrical cables.

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Figure 3. 2008K2Hemodialysis System, Rear View.
DIALYSATE LINE
CONN. O-RINGS
P/N 579097
FLOW PUMP
OUTLET
UF PUMP
ADJUSTMENT
BLOOD PRESSURE
MODULE
INLET PRESSURE
REGULATOR
DRAIN PORT
DEAERATION PUMP
INLET
9-VOLT BATTERY
STRAIN
RELIEF
HEATER
CONNECTIONS
INLET WATER FILTER
P/N 330636
HEATER ELEMENT
P/N 250169
REDUNDANT
GROUND
BICARBONATE PUMP
ACID PUMP BEHIND
INLET PRESSURE
REGULATOR
DIALYSATE
INLINE FILTER
P/N 650113

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2.1 FILTERS
Clean filters as follows. Replace any filters that appear damaged or corroded.
1. Inlet Water Filter in the inlet connector of the water supply (See Figure 3, pg. 9).
Warning! After cleaning or replacing the inlet filter screen, disinfect the water inlet line as described in the Operator’s manual and in accordance with
your Unit Policy.
2. Filters in the Concentrate and Bicarbonate Connectors (See Figure 4.).
Figure 4. Concentrate and Bicarbonate Connector Assemblies.
3. Clean the Dialysate Inline filter (See Figure 3, pg. 9).
2.2 PRE-UF PUMP FILTER
Inspect the Pre-UF Pump filter for leaks or distortion. Replace the Pre-UF Pump
Filter if leakage or distortion is found.
Caution: Do not attempt to disassemble the Pre-UF Pump Filter. If not
properly reassembled, the Pre-UF Pump filter may leak. A leak in the
hydraulic system at this location may affect the operation of the machine or
cause fluid loss from the patient.
FILTER INSERT P/N 566307

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2.3 UF PUMP CHECK VALVES
Caution: If a check valve is replaced, ensure it is oriented correctly to allow
fluid flow in the proper direction.
Inspect the UF pump Output check valves (one at the UF pump output and the other
downstream at the UF Sample Port). Replace any that show signs of wear, damage
or leaking.
2.4 HIGH VOLTAGE AC CONNECTIONS
Shock Hazard: Dangerous high voltage is present at the connections
accessed in this procedure when the machine is operating. Ensure the
machine's power plug is disconnected from the wall outlet before proceeding.
1. Remove power from the machine then check and tighten the 8-pin heater
connections next to the distribution board (See Figure 3, pg. 9). Check
heater block AC connections for signs of arcing or melting.
2. If applicable, inspect the power plug for loose or frayed wires. Ensure the
strain relief is securely fastened.
3. Inspect the entire length of the power cord (from plug to strain relief) for
nicks or cuts in the insulation and replace if necessary (part number
150425).
4. Confirm that the strain relief is tightly secured to the power supply chassis.
5. At the strain relief, locate the black, white and green wires from the power
cord (inside the power supply chassis). Follow the black and white wires to
the main power switch. Attached to the main power switch are four (4)
wires (2 black and 2 white). Look for loose connections, cracked insulation,
and signs of overheating, such as discolored or melted insulation. Replace
wires with power supply wire kit (part number 190411).
6. Inspect the main power switch and verify that its operation is smooth (no
grinding or sticky operation) and that the wires are not crossed.

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Shock Hazard: Do not operate the machine if the resistance is greater than
0.2 ohm. A shock hazard to operators and patients could exist.
7. With a digital multimeter, measure the resistance between the round
(ground) pin on the power plug and the redundant ground terminal on the
machine (See Figure 3, pg. 9). Verify that the resistance is less than or
equal to 0.2 ohm. If the value is above 0.2 ohm, measure the internal
resistance of your meter by shorting the leads together, then subtract this
value from the resistance measured between the power plug ground pin and
the redundant ground terminal on the machine to obtain the true ground
resistance.
8. Record the measured value on either the Six (6) Month Preventive
Maintenance Checklist or the Annual/4000 Hour Preventive Maintenance
Checklist depending upon which is being performed.
9. Perform the electrical safety checks required by local codes, facility
procedure and the Joint Commission on Accreditation of Healthcare
Organizations.
2.5 UF PUMP
Calibrate the UF Pump Volume (Refer to the 2008K2Calibration Procedures – part
number 508137.)
Record the measured value on the Six (6) Month Preventive Maintenance Checklist.
2.6 CONDUCTIVITY
Verify that the dialysate conductivity measured by the internal cell in the machine
agrees with an external conductivity meter within 0.1mS/cm as follows:
1. Connect an external conductivity meter to the dialysate lines.
2. With the machine in Dialysis Mode and flow ON, compare the value shown
on the external conductivity meter with the conductivity shown on the
Display screen. They must be within 0.1mS/cm of each other.
3. Record the measured value on either the Six (6) Month Preventive
Maintenance Checklist or the Annual/4000 Hour Preventive Maintenance
Checklist depending upon which is being performed.

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2.7 TEMPERATURE
Verify that the actual dialysate temperature measured by an external temperature
meter agrees with the display screen within 0.3°C at 37°C and 39°C as follows:
1. Connect the dialysate lines to an external temperature meter.
2. Place the machine in Dialysis Mode with concentrate in the system. Clear
any alarms.
3. Select1the Temperature button. The button label will change to Temp.
Setting. The value now displayed on this button is the temperature set
point. Adjust the temperature set point to exactly 37.0 then press the
[CONFIRM] key. The button will change back and now reads the actual
temperature of the dialysate again. Wait until this value stabilizes. It will
settle very close to the value set, depending upon inlet water temperature
and other conditions.
4. After the temperature of the dialysate stabilizes, compare the temperature
shown on the Temperature button with the temperature shown on the
external temperature meter connected to the dialysate lines. The two
readings must be within 0.3°C of each other.
5. Record the measured value on either the Six (6) Month Preventive
Maintenance Checklist or the Annual/4000 Hour Preventive Maintenance
Checklist depending upon which is being performed.
6. Repeat steps 3 and 4 with the temperature set to 39.0°C. Verify that the
actual temperature reported on the front panel display screen and the
external temperature meter are within 0.3°C of each other after the
temperatures stabilize again.
7. Record the measured values on either the Six (6) Month Preventive
Maintenance Checklist or the Annual/4000 Hour Preventive Maintenance
Checklist depending upon which is being performed.
1Refer to Section 1.3 on the use of screen buttons.

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2.8 ALARM OPERATION AND PRESSURE HOLDING TESTS
Verify the automatic alarms produce the responses shown in Table 1 and the machine
passes the automatic pressure holding test as follows:
1. Place the dialysate lines in the shunt and close the door.
Warning! The use of a “test drip chamber” or “dummy drip chamber” must never be used on the treatment floor. It must only be used in a controlled
technical environment.
2. Place a venous chamber filled with water in the holder on the level detector
module.
3. Place the machine in Dialysis mode and start the blood pump. Clear all
blood and water alarms.
4. Select1the Test & Options screen key. On this screen select1the Both
Tests button. Press the [CONFIRM] key to start.
5. Observe the machine stepping through the following alarm tests and ensure
that each alarm produces all of the responses shown in Table 1.
1Refer to Section 1.3 on the use of screen buttons.