Copyright ¤ 2000 - 2012 Fresenius Medical Care North America
rinted 5/18/2012 12:00PM
C
P
NOTE
Eligibility for semi-annual preventive maintenance program.
Standard preventive maintenance procedures for the Fresenius 2008K
Hemodialysis System are documented in Fresenius P/N 507297 Fresenius
2008K Hemodialysis System Preventive Maintenance Procedures. The
standard PM procedure manual lists maintenance tasks and checks to be
performed at 1000 and 4000 hour intervals.
TIVE
FFE
Fresenius 2008K Hemodialysis Systems manufactured (or refurbished) in
2003 and later may be qualified for the semi-annual preventive maintenance
procedures described in this manual. In addition, 2008K hemodialysis
systems manufactured (or refurbished) in 2002 and earlier may be qualified for
the semi-annual PM procedures if the machine meets the minimum
configuration in the qualification checklist on page 69 and that configuration
is maintained.
Since modules and the power supply are designed to be easily moved from
machine to machine, it is necessary to label machines & modules that meet the
configuration requirements for the semi-annual PM program so that the status
of the machine is known and the minimum configuration of the machine is
maintained.
2.7 TEMPERATURE ...................................................................................................................................... 12
2.8 ALARM AND PRESSURE HOLDING TESTS ........................................................................................... 13
2.9 POWER FAILURE ALARM ...................................................................................................................... 15
2.10 FINAL CHECKS ....................................................................................................................................... 16
3.1 FILTERS AND O-RINGS .......................................................................................................................... 17
3.6 HEATER ELEMENT ................................................................................................................................. 19
3.7 HIGH VOLTAGE AC CONNECTIONS ...................................................................................................... 19
3.8 DEAERATION MOTOR BRUSHES .......................................................................................................... 20
3.9 INLET WATER PRESSURE REGULATOR .............................................................................................. 21
3.10 ONLINE CLEARANCE TEST (IF APPLICABLE)....................................................................................... 22
3.11 DEAERATION AND LOADING PRESSURE ............................................................................................ 26
3.16 TEMPERATURE ...................................................................................................................................... 28
3.17 VOLT HI LO DETECT ............................................................................................................................... 28
3.18 BLOOD LEAK AND DIMNESS ................................................................................................................. 29
3.19 ARTERIAL, VENOUS AND TRANSMEMBRANE PRESSURE ................................................................. 30
3.28 FINAL CHECKS ....................................................................................................................................... 48
4.1 REBUILDING THE ULTRAFILTRATION PUMP ....................................................................................... 49
4.2 REBUILDING THE CONCENTRATE AND BICARBONATE PUMPS ........................................................ 52
4.3 TESTING CONCENTRATE AND BICARBONATE PUMPS ...................................................................... 54
Shock hazard. Refer servicing to qualified personnel.
Failure to install, operate and maintain this equipment according
to the manufacturer’s instructions may cause patient or operator
injury or death.
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.
Page iv
NOTE
This document is written for Fresenius 2008K Hemodialysis
Systems using software versions 2.16 or later.
Preventive Maintenance for the Fresenius 2008K Hemodialysis 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 recalibrate 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.
TIVE
1.1 TEST EQUIPMENT AND SUPPLIES NEEDED
FFE
A number of small parts must be available to perform the Preventive Maintenance.
Fresenius 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! All of the test equipment used must be maintained and calibrated
regularly in accordance with NIST standards. In particular, the conductivity meter
must meet the specifications given below. Failure to do so could result in injury or
death to the patient or to the operator.
Warning! Disinfect the machine internally and externally and check all pressure
transducer protectors for contamination before working on the machine.
xFresenius Test Kit (Fresenius part number 150034), which contains two gauges
with fittings and hoses for measuring loading pressure and deaeration pressure.
xDialysate 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.
xStopwatch with a resolution to 0.01 second and an accuracy of 0.01% or better.
xFresenius Buret, 25ml capacity with 0.1ml graduations (Fresenius part number
290104).
xGraduated cylinder: 1000ml capacity with a tolerance of 5.0ml at 1000ml or
better.
xSyringe, 60cc capacity. Tolerance is not important; the syringe is not used for
volume measurements.
FFE
xTubing, 24” long (Fresenius part number 545325-10). Use on the tip of the
Buret.
xResistor Plug Set for OLC Testing (Fresenius part number 190168).
The following equipment is also required to test the blood pressure module:
xTest Device (Fresenius part number 370090). The Test Device contains two air
chambers with calibrated volumes.
xMercury manometer or equivalent pressure meter accurate to within 1mmHg at
The following preventive maintenance 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
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.
FFE
Figure 1 - 2008K Front 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.
A yellow data button is used 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.
Some data buttons will change the screen and the data entry
will
be performed on the new screen.
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 preventive maintenance process this
type of box is used to verify a value or selection.
C
TIVE
P
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. Select a
parameter for which data will be entered using the keys below the screen.
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 preventive maintenance process.
Several of the following procedures require measuring fluid volumes using graduated
cylinders and laboratory burets. When making these measurements do the following:
xMake 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.
xEnsure 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.
xSurface tension causes the fluid to curve into a meniscus (See Figure 2).
Measure the volume at the bottom of the meniscus curve as shown.
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.
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.
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 8).
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.
Warning! Do not use excessive O-ring lubricant, as silicone-gel can
damage the hydraulic pressure transducers (P-DIAL and CFS).
2. Filters in the Concentrate and Bicarbonate Connectors (See Figure 4).
3. Dialysate Inline filter (See Figure 3, pg 8).
TIVE
FFE
2.2 PRE-UF PUMP FILTER
FILTER INSERT P/N 566307
Figure 4 - Concentrate and Bicarbonate Connector Assemblies.
4. Replace o-rings in the Dialysate Line Connectors (See Figure 3, pg 8).
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.
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
Warning! 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.
TIVE
FFE
1. Remove power from the machine then check and tighten the 8-pin heater
connections on the distribution board (See Figure 3, pg 8). 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 (Fresenius 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 (Fresenius 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.
7. With a digital multimeter, measure the resistance between the round
P
(ground) pin on the power plug and the redundant ground terminal on the
machine (See Figure 3, pg 8). Verify that the resistance is less than 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.
Warning! Do not operate the machine if the resistance is greater than 0.2
ohm. A shock hazard to operators and patients could exist.
8. 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 2008K Calibration Procedures –
Fresenius part number 507296.)
2.6 CONDUCTIVITY
Verify that the dialysate conductivity measured by the internal cell in the machine
agrees with an external 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 meter with the conductivity shown on the Display screen.
They must be within 0.1mS/cm of each other.
Verify that the actual dialysate temperature measured by an external meter agrees
with the display screen within 0.5qC at 37qC and 39qC as follows:
1. Connect the dialysate lines to an external meter.
2. Place the machine in Dialysis Mode with concentrate in the system. Clear
any alarms.
3. Select the 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 meter connected to the dialysate lines. The two readings must be
within 0.5q of each other.
FFE
5. Repeat steps 3 and 4 with the temperature set to 39.0qC. Verify that the
actual temperature reported on the front panel display screen and the
external meter are within 0.5q of each other after the temperatures stabilize
again.
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 Dialyze mode and start the blood pump. Clear all
blood and water alarms.
4. Select the Test & Options button. On this screen press the 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.
6. When the tests shown in Table 1 are complete, the machine conducts a
pressure holding test. When the test ends verify that the display screen
reports TEST COMPLETE, indicating that all the tests were passed
successfully. Press the [RESET] key.
7. Test the UF pump integrity as follows:
xPull the hydraulics out and remove the output tube from the UF pump.
xInstall a 24” tube (Fresenius part number 545325-10) to the empty
output port. Route this tubing out the back of the machine so that it
will not be kinked or pinched when the hydraulics is closed. Close the
hydraulics and place the other end of tube into a collection container.
xConduct steps 1-6 again.
-If the pressure holding test fails, refer to Section 4.1.
-If the pressure holding test passes, disconnect the 24” tube and
reconnect the original output tube to the UF pump.
FFE
2.9 POWER FAILURE ALARM
8. Test the audible alarm as follows:
xPlace a piece of opaque paper inside the housing of the optical detector
to simulate a line containing blood. Close the door of the optical
detector.
xOpen the shunt door. Verify that the machine responds with an
audible alarm. Press the [Mute] key and verify that the Mute lamp
lights, and the audible tone stops.
Test the Power Failure alarm by turning the main power switch off on the back of the
power supply with the machine powered on. Verify that the audible alarm sounds. If
no audible alarm occurs, check/replace the 9-Volt battery.
Before returning the machine to clinical use after successful completion of all of the
Preventive Maintenance procedures listed above, complete the following:
xVerify that the machine label with serial number is in place, usually on the back
of the cabinet near the Monitor Control Unit or above the quick connectors of the
open shunt door assembly. Record this serial number on the Preventive
Maintenance Checklist form.
xVerify that no dialysate spills or leaks are visible in the hydraulics or on the
bottom of the cabinet. Clean and dry any spills found and correct the source.
xVerify that all cables are properly routed to prevent pinching or chaffing.
xVerify that all covers are replaced and that all cover screws and mounting
hardware has been replaced.
TIVE
FFE
Caution: Reliable operation of the machine requires that all screws and covers
be properly installed. Ensure that all screws and covers are in place before
returning the machine to clinical use.
xClean the exterior surfaces of the machine and remove all traces of dirt, oil or
other contaminants.
Caution: Do not use a cleaner containing Dimethyl Benzylammonium
Chloride. This ingredient will damage many plastic surfaces. Certain brands of
cleaners specifically marketed to clinics and hospitals contain this ingredient.
Check the contents of any unknown cleaner before using it.
Perform the following Preventive Maintenance procedures every 12 months or
4000 hours of machine operation, whichever comes first. Perform the procedures
in the order given below to complete the Annual Preventive Maintenance.
Make copies of the Annual Preventive Maintenance Checklist provided at the back
of this manual and use them to record the maintenance done.
Clean filters and replace O-rings 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 8).
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.
Warning! Do not use excessive O-ring lubricant, as silicone-gel can
damage the hydraulic pressure transducers (P-DIAL and CFS).
FFE
2. Filters and O-rings in the Concentrate and Bicarbonate Connectors
(See Figure 5). Replace all three O-rings in each connector.
FILTER INSERT P/N 566307
O-RING P/N 579092
Figure 5 - Concentrate and Bicarbonate Connector Assemblies.
3. Dialysate Inline filter (See Figure 3, pg 8).
4. O-rings in the Dialysate Line Connectors (See Figure 3, pg 8).
Replace the Pre-UF Pump Filter (Fresenius part number 672574).
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.
Caution: Ensure each check valve is oriented correctly to allow fluid flow in the
proper direction.
Replace the UF Pump Output check valves. There are two check valves at the UF pump
output. One is at the UF pump itself. The other is downstream at the UF Sample Port.
3.4 DEAERATION RESTRICTOR
FFE
3.5 DIAPHRAGM PUMPS
Note: On newer machines with hydrochamber assemblies the deaeration restrictor is
a glass bead with a fixed orifice built into one of the hydrochamber interconnecting
tubes. Since there are no o-rings in this type of setup, disregard this step. If a screw
is present in the back side of the hydroblock proceed with the following check.
With the machine off, replace the deaeration restrictor O-rings by clamping the
hydroblock vent tube and removing the deaeration restrictor from the hydroblock (See
Figure 3, pg 8). Replace the two O-rings on the deaeration restrictor (Fresenius part
number 579070). Clean any debris that may be present in the angled hole at the tip of
the deaeration restrictor.
Rebuild the UF, Bicarbonate and Concentrate diaphragm pumps as described in
Section 4.1 and 4.2.