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FRESENIUS 2008K
HEMODIALYSIS
SYSTEM
PREVENTIVE
MAINTENANCE
PROCEDURES
Part Number 507297 Rev. H
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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: __________________________________
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FRESENIUS 2008K
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HEMODIALYSIS SYSTEM
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PREVENTIVE MAINTENANCE
PROCEDURES
Part Number 507297 Rev. H
INCLUDING
PREVENTIVE MAINTENANCE CHECKLISTS
QUARTERLY/1000 HOUR AND ANNUAL/4000 HOUR
http://www.fmcna.com
Copyright ¤ 2000 - 2012 Fresenius Medical Care North America
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WARNINGS
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.
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1.0 INTRODUCTION ............................................................................................................................................1
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1.1 TEST EQUIPMENT AND SUPPLIES NEEDED .............................................................................................1
1.2 OPERATING MODES .................................................................................................................................... 3
1.3 FRONT PANEL CONTROLS ......................................................................................................................... 4
1.4 MEASURING FLUID VOLUMES ...................................................................................................................6
2.0 QUARTERLY (1000 HOUR) PREVENTIVE MAINTENANCE .......................................................................7
3.0 ANNUAL (4000 HOUR) PREVENTIVE MAINTENANCE ............................................................................23
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4.0 REBUILDING THE DIAPHRAGM PUMPS ..................................................................................................52
PREVENTIVE MAINTENANCE CHECKLIST QUARTERLY/1000 HOUR ........................................................... 61
PREVENTIVE MAINTENANCE CHECKLIST ANNUAL/4000 HOUR ..................................................................63
PREVENTIVE MAINTENANCE PROCEDURES
TABLE OF CONTENTS
2.1 FILTERS AND O-RINGS ............................................................................................................................ 9
2.2 DIASAFE
2.3 CHECK VALVES ...................................................................................................................................... 10
2.4 HIGH VOLTAGE AC CONNECTIONS ...................................................................................................... 11
2.5 UF PUMP ................................................................................................................................................. 12
2.6 CONDUCTIVITY ...................................................................................................................................... 12
2.7 TEMPERATURE ...................................................................................................................................... 12
2.8 LEVEL DETECTOR ................................................................................................................................. 13
2.9 ALARM AND PRESSURE HOLDING TESTS ........................................................................................... 17
2.10 POWER FAILURE ALARM ....................................................................................................................... 19
2.11 BLOOD PUMP ROTOR INSPECTION ...................................................................................................... 20
2.12 FINAL CHECKS ....................................................................................................................................... 22
3.1 FILTERS AND O-RINGS .......................................................................................................................... 23
3.2 PRE-UF PUMP FILTER ............................................................................................................................ 23
3.3 CHECK VALVES ...................................................................................................................................... 23
3.4 DEAERATION RESTRICTOR .................................................................................................................. 24
3.5 DIASAFE
3.6 DIAPHRAGM PUMPS .............................................................................................................................. 24
3.7 HEATER ELEMENT ................................................................................................................................. 25
3.8 HIGH VOLTAGE AC CONNECTIONS ...................................................................................................... 25
3.9 DEAERATION MOTOR BRUSHES .......................................................................................................... 26
3.10 INLET WATER PRESSURE REGULATOR .............................................................................................. 27
3.11 ONLINE CLEARANCE TEST (IF APPLICABLE) ....................................................................................... 28
3.12 DEAERATION AND LOADING PRESSURE............................................................................................. 32
3.13 FLOW RELIEF PRESSURE ..................................................................................................................... 33
3.14 CONCENTRATE AND BICARB PUMPS .................................................................................................. 34
3.15 UF PUMP ................................................................................................................................................. 34
3.16 CONDUCTIVITY ...................................................................................................................................... 34
3.17 TEMPERATURE ...................................................................................................................................... 34
3.18 VOLT HI LO DETECT ............................................................................................................................... 34
3.19 BLOOD LEAK AND DIMNESS ................................................................................................................. 35
3.20 ARTERIAL, VENOUS AND TRANSMEMBRANE PRESSURE ................................................................. 36
3.21 DIALYSATE FLOW .................................................................................................................................. 39
3.22 HEPARIN PUMP ...................................................................................................................................... 39
3.23 BLOOD PUMP ......................................................................................................................................... 42
3.24 LEVEL DETECTOR ................................................................................................................................. 44
3.25 ALARM AND PRESSURE HOLDING TESTS ........................................................................................... 44
3.26 RINSE CHECKS ...................................................................................................................
3.27 BATTERY AND POWER FAILURE ALARM .............................................................................................. 46
3.28 BLOOD PRESSURE MODULE ................................................................................................................ 47
3.29 FINAL CHECKS ....................................................................................................................................... 51
4.1 REBUILDING THE ULTRAFILTRATION PUMP........................................................................................ 52
4.2 REBUILDING THE CONCENTRATE AND BICARBONATE PUMPS ........................................................ 55
4.3 TESTING CONCENTRATE AND BICARBONATE PUMPS ...................................................................... 57
FILTER (IF APPLICABLE) ...................................................................................................... 10
FILTER (IF APPLICABLE) ...................................................................................................... 24
................... 45
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NOTE
This document is written for Fresenius 2008K
Hemodialysis Systems using software versions
2.16 or later.
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1.0 INTRODUCTION
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1.1 TEST EQUIPMENT AND SUPPLIES NEEDED
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Preventive Maintenance for the Fresenius 2008K Hemodialysis System is simple and
straightforward. Maintenance is performed in only two intervals: Quarterly or after
1000 hours of operation, 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.
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:
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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.
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x Fresenius Test Kit (Fresenius part number 150034), which contains two gauges
with fittings and hoses for measuring loading pressure and deaeration pressure.
x 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.
x Stopwatch with a resolution to 0.01 second and an accuracy of 0.01% or better.
x Fresenius Buret, 25ml capacity with 0.1ml graduations (Fresenius part number
290104).
x Graduated cylinder: 1000ml capacity with a tolerance of 5.0ml at 1000ml or
better.
x Syringe, 60cc capacity. Tolerance is not important; the syringe is not used for
volume measurements.
x Tubing, 24” long (Fresenius part number 545325-10). Use on the tip of the
Buret.
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x Resistor Plug Set for OLC Testing (Fresenius part number 190168).
The following equipment is also required to test the blood pressure module:
x Test Device (Fresenius part number 370090). The Test Device contains two air
chambers with calibrated volumes.
x Mercury manometer or equivalent pressure meter accurate to within 1mmHg at
pressures up to 330mmHg.
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1.2 OPERATING MODES
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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
machine will be in Dialysis Mode.
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1.3 FRONT PANEL CONTROLS
Control Panel
Touch Screen
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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.
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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.
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Data Button
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
c
hanges 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.
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Touch Screen Operation
The touch screen is designed to display information and is used to enter data. To
select a button during a procedure, locate the button on the screen. 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.
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1.4 MEASURING FLUID VOLUMES
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Several of the following procedures require measuring fluid volumes using
graduated cylinders and laboratory burets. When making these measurements do the
following:
x 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.
x 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.
x 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.
BOTTOM OF
MENISCUS
CURVE
Figure 2. Meniscus Curve.
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2.0 QUARTERLY (1000 HOUR) PREVENTIVE MAINTENANCE
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Perform the following Preventive Maintenance procedures every 3 months or
1000 hours of machine operation, whichever comes first. Make copies of the
Quarterly 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 quarterly
procedures below first. Go directly to Section 3 and perform the annual procedures
described there. You will be referred back to this section to perform the quarterly
procedures along with the annual procedures in the most efficient order.
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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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
DIALYSATE
INLINE FILTER
P/N 650113
REDUNDANT
GROUND
BICARBONATE PUMP
ACID PUMP BEHIND
INLET PRESSURE
REGULATOR
DEAERATION RESTRICTOR
O
-RINGS P/N 579070
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Figure 3. Fresenius 2008K Hemodialysis System, Rear View.
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2.1 FILTERS AND O-RINGS
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).
2. Filters and O-rings in the Concentrate and Bicarbonate Connectors
(See Figure 4). Replace all three O-rings in each connector.
TI
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FILTER INSERT P/N 566307
Figure 4. 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).
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5. Pre-UF Pump Filter. Inspect the Pre-UF Pump filter for leaks or distortion.
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2.2 DIASAFE
If the machine is equipped with a DIASAFEor DIASAFEPLUS filter system,
replace the filter every 90 days (quarterly). After replacing the filter, perform either
the automated test function or a manual pressure holding test AND then perform the
DIASAFE
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 (IF APPLICABLE)
filter integrity test.
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2.3 CHECK VALVES
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Note: If the machine is equipped with a DIASAFE
connector O-rings (Fresenius part number 579097) when replacing the filter.
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 and the other
downstream at the UF Sample Port). Replace any that show signs of wear, damage
or leaking.
filter, replace its quick
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2.4 HIGH VOLTAGE AC CONNECTIONS
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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.
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
(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.
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2.5 UF PUMP
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2.6 CONDUCTIVITY
2.7 TEMPERATURE
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Calibrate the UF Pump Volume (Refer to the 2008K Calibration Procedures –
Fresenius part number 507296.)
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.
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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.
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 is
within 0.5q of each other after the temperatures stabilize again.
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2.8 LEVEL DETECTOR
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Caution: In the following steps, the level detector must be removed from the machine
cabinet. Before returning it to the cabinet, wipe the lower edge of the module and the
level detector cabinet opening to remove any residual disinfecting agent. When
installing the module screws do not use a power screwdriver.
ALARM TEST
1. Calibrate level detector (Refer to Section 3.2 of the 2008K Calibration
Procedures – Fresenius part number 507296).
2. Place the machine in Dialysis Mode and turn the blood pump ON. Insert a
water filled venous chamber into the level detector and clear all alarms.
3. Position the Level Detector so you can watch the Channel 1 and Channel 2
LED's on the circuit board (See Figure 6 on page 15).
4. While watching the Channel 1 and Channel 2 LED's, remove the venous
chamber to create a blood alarm and close the occlusion clamp. Verify that
the Channel 1 LED lights first followed quickly by Channel 2.
OCCLUSION CLAMP TEST
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1. Place a venous line into the closed occlusion clamp. Do not connect this
line to the venous chamber in the level detector.
2. Place the lower end of the venous line below the occlusion clamp in a
container of water positioned so that air escaping from the end of the line is
easily seen.
3. Connect a syringe and a pressure gauge to the venous line above the
occlusion clamp.
4. With the syringe, apply a pressure of at least 30psi (1550mmHg) to the
venous line while watching the end of the venous line in the water.
5. Verify that no air escapes from the venous line, indicating that the clamp is
fully occluding the line.
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RELAY CONTACT TEST
A relay prevents the level up and level down membrane keys on the face of the
level detector to function if they are pressed at the same time.
Various module configurations are available. Use the following information to
select the correct method to use to check the relay contacts:
x Use Method 1 if LP450 has LED’s D6 & D19 (See Figure 5)
x Use Method 2 if LP450 does not have relay test LED’s then locate a separate
relay board LP1026 with test LED’s D3 & D4 (See Figure 5).
x Use Method 3 if LP1026 is present and does not have LED’s D3 & D4
(See Figure 6).
Method 1:
1. With the machine in Dialysis Mode and the blood pump turned ON, insert a
water filled venous chamber into the level detector and clear all alarms
2. Locate the relay test LED’s D6 and D19 on the LP450 board.
3. To test the LED’s, press the level down switch on the face of the level
detector and verify that both LED’s D6 and D19 light. The on-board air
pump will also run. If both LED’s light, proceed to step 4.
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Note: If either LED doesn’t light during the LED test (step 3), then the results
of the Relay Contact Test (step 4) would be invalid. In this case use Method 3
instead.
While in alarm condition (clamp closed), attach the ground lead of a voltmeter
to TP3 (ground) on the LP450 board. Measure the voltage on the solder side of
pins 1 and 2 of X153 on the LP450 board. Verify that both pins are 0 volts. If
voltage is present, the relay contacts are bad.
4. To test the relay contacts, remove the venous chamber to create a blood
alarm and verify that both LED’s D6 and D19 do not light when the level
down switch is pressed. If either LED lights, the relay contacts are bad.
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CHANNEL 1 LED
LIGHTS FIRST
CHANNEL 2 LED
LIGHTS SECOND
X4 ON RELAY
BOARD LP1026
TP3 (GROUND)
RELAY CONTACT TEST
LED’S D19 & D6 ON LP450
BOARD WHEN LP1026 IS
NOT PRESENT
X153 ON LP450
RELAY CONTACT
TEST LED’S D3 & D4
ON LP1026 BOARD.
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Figure 5 - Level Detector with Relay Contact Test LED’s.
Figure 6 - Level Detector without Relay Contact Test LED’s.
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Method 2:
1. With the machine in Dialysis Mode and the blood pump turned ON, insert a
water filled venous chamber into the level detector and clear all alarms.
2. Locate the relay test LED’s D3 and D4 on the LP1026 board.
3. To test the LED’s, press the level down switch on the face of the level
detector and verify that both LED’s D3 and D4 light. The on-board air
pump will also run. If both LED’s light, proceed to step 4.
Note: If either LED doesn’t light during the LED test (step 3), then the results
of the Relay Contact Test (step 4) would be invalid. In this case use Method 3
instead.
4. To test the relay contacts, remove the venous chamber to create a blood
alarm and verify that both LED’s D3 and D4 do not light when the level
down switch is pressed. If either LED lights, the relay contacts are bad
Method 3:
1. With the machine in Dialysis Mode and the blood pump turned ON, insert a
water filled venous chamber into the level detector and clear all alarms
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2. Locate the solder side of X4 on the LP1026 (or X153 on the LP450).
3. Attach the ground lead of a voltmeter to TP3 (ground) on the LP450 board.
4. Test for 24 volts at X4 (X153) by pressing the level down switch on the face
of the level detector and verify that both pins 1 and 2 on the solder side of
X4 (X153) are 24 volts.
5. To test the relay contacts, remove the venous chamber to create a blood
alarm and measure the voltage on the solder side of pins 1 and 2 of X4
(X153). Verify that both pins are 0 volts. If voltage is present, the relay
contacts are bad.
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Page 23
2.9 ALARM AND PRESSURE HOLDING TESTS
C
P
TIVE
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.
FFE
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Page 24
Table 1. Alarm Tests.
ALARM TEST
RESPONSE
Machine in Bypass mode (no flow through the
Machine in Bypass mode (no flow through the
C
P
TIVE
FFE
Air Detector
Blood Leak
Arterial Pressure
Venous Pressure
TMP
9-Volt Battery
Optical Detector
1. Red visual alarm
2. Venous clamp closes
3. Blood pump stops
1 Red visual alarm
2. Venous clamp closes
3. Blood pump stops
1. Red visual alarm
2. Venous clamp closes
3. Blood pump stops
1. Red visual alarm
2. Venous clamp closes
3. Blood pump stops
1. Red visual alarm
2. Venous clamp closes
3. Blood pump stops
Passes if battery voltage is greater than 7.0
volts under a load of 22:.
1. Lower venous alarm limit rises to 10mmHg
causing a venous pressure alarm
2. Venous clamp closes
3. Blood pump stops
Temperature
Conductivity
1. Red visual alarm
2. Yellow visual bypass
3.
dialysate flow indicator).
1. Red visual alarm
2. Yellow visual bypass
3.
dialysate flow indicator).
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Page 25
6. When the tests shown in Table 1 are complete, the machine conducts a
C
P
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:
x Pull the hydraulics out and remove the output tube from the UF pump.
x Install 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.
x Conduct 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.
8. Test the audible alarm as follows:
TIVE
FFE
2.10 POWER FAILURE ALARM
x Place 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.
x Open 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.
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Page 26
2.11 BLOOD PUMP ROTOR INSPECTION
C
P
TIVE
Clean and inspect the arterial blood pump rotor assembly as follows:
1. Remove the blood pump rotor by opening the door, pulling out the crank
lever and turning the rotor 90 degrees.
2. Clean the rollers with a cloth dampened only with water.
3. With the crank lever pulled out, locate and lubricate the crank lever retainer
ball. See Figure 7 for assistance. If the crank lever is hard to pull out,
replace the crank lever retainer assembly (Fresenius part number 564301).
4. Clean the inside of the blood pump housing with the damp cloth.
Compressed air may be used if it is available.
5. Locate the four (4) tubing guides. See Figure 7 for assistance. If any of the
four (4) tubing guides are missing, the rotor assembly needs to be replaced
(Fresenius part number M30990).
Tubing Guides
Tubing Guide
FFE
SIDE VIEW
Crank Lever
TOP VIEW
Figure 7. Blood Pump Rotor Assembly
Crank Lever
Retainer
Tubing Guide
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Page 27
Note: On newer blood pump rotors (M30990) the plastic sleeves are not
C
P
replaceable. If sleeves are damaged, replace the rotor assembly.
6. On each of the tubing guides there is a plastic sleeve that should rotate
smoothly. Inspect each plastic sleeve for smooth operation. If any of the
plastic sleeves are missing, damaged, or do not rotate smoothly, replace with
a new plastic sleeve. See Figure 8 for an exploded view and Fresenius part
numbers.
TIVE
FFE
Solid Guide
Post
Plastic Sleeve
P/N 641256
Tubing Guide
(Exploded View)
Figure 8. Tubing Guide (Exploded View)
7. Without removing the plastic sleeve, inspect the solid guide post on all four
(4) tubing guides. The solid guide post should not be loose or bent. If any
of the solid guide posts are loose or bent, the rotor assembly needs to be
replaced. (Fresenius part number M30990).
Note: The plastic sleeve will make it feel like the solid guide post is loose.
When inspecting, pay close attention to the movement of the metal shaft.
Sleeve Retaining
Screw P/N 552255
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Page 28
2.12 FINAL CHECKS
C
P
TIVE
Before returning the machine to clinical use after successful completion of all of the
Preventive Maintenance procedures listed above, complete the following:
x Verify 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.
x Verify 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.
x Verify that all cables are properly routed to prevent pinching or chaffing.
x Verify that all covers are replaced and that all cover screws and mounting
hardware has been replaced.
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.
FFE
x Clean 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.
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Page 29
3.0 ANNUAL (4000 HOUR) PREVENTIVE MAINTENANCE
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3.1 FILTERS AND O-RINGS
3.2 PRE-UF PUMP FILTER
TIVE
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 and the
Quarterly Preventive Maintenance. The following procedures will refer back to
the Quarterly Preventive Maintenance procedures at the proper times for you to
work in the most efficient manner.
Make copies of the Annual Preventive Maintenance Checklist provided at the back
of this manual and use them to record the maintenance done.
Perform the Quarterly Preventive Maintenance procedures in Sections 2.1.
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.
FFE
3.3 CHECK VALVES
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.
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Page 30
3.4 DEAERATION RESTRICTOR
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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. Reinstall deaeration restrictor.
3.5 DIASAFE
Perform the Quarterly Preventive Maintenance procedures in Sections 2.2.
FILTER (IF APPLICABLE)
TIVE
3.6 DIAPHRAGM PUMPS
FFE
Rebuild the UF, Bicarbonate and Concentrate diaphragm pumps as described in
Section 4.1 and 4.2.
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Page 31
3.7 HEATER ELEMENT
C
P
TIVE
Warning! Dangerous high voltage is present at these connections when the
machine is operating. The heater element is hot enough to inflict serious injury
if it is touched while power is applied or shortly after power is removed. Ensure
the machine is disconnected from the wall outlet.
1. Remove the rear access panels and distribution board cover so that the wires of
the heater are accessable.
Note: If the heater element is replaced, replace the heater O-ring as well
(P/N 579075).
2. Remove the heater element from the hydroblock on the machine (See Figure 3,
pg. 8). Inspect the heater element for signs of corrosion. If corrosion exists,
replace the heater element.
3. Attach one lead of the voltmeter to the ground (yellow / green wire) and the
other lead to the brown or blue wire. Measure the resistance. Resistance should
be “ OL “ or greater than 19.9 meg-ohms. If this is not the case, replace the
heater element.
FFE
3.8 HIGH VOLTAGE AC CONNECTIONS
4. After completing this check, reinstall the heater and O-ring.
Perform the Quarterly Preventive Maintenance procedures in Sections 2.4.
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Page 32
3.9 DEAERATION MOTOR BRUSHES
Use Marker to make
marks to ensure proper
reassembling of motor
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P
Replace the deaeration motor brushes every 8000 hrs using the following steps:
1. Remove the complete deaeration motor/pump assembly from the machine.
2. Using a marker, make marks on the motor housing and motor cap as
illustrated below. These marks will ensure the correct alignment when
reassembling the motor case.
Use marker to make hatch
marks to ensure proper
reassembling of motor
Motor Cap
TIVE
FFE
Figure 9. Deaeration Motor/Pump Assembly with marks.
3. Using a T-25 Torx screwdriver, remove the two screws holding the motor
cap to the motor housing.
4. Remove the motor cap to gain access to the motor brushes. Replace the
motor brushes.
5. Reassemble the motor, aligning the marks.
6. While holding the pieces together, install and tighten the two T-25 screws.
Note: If the motor case and motor cap are not installed using the marks,
the motor will run in reverse and flow errors will result.
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Page 33
3.10 INLET WATER PRESSURE REGULATOR
C
P
TIVE
Verify that the regulator provides the proper water pressure as follows:
1. Shut off the water supply to the machine.
2. Install a gauge with a T-fitting to monitor the pressure at the outlet side of
the Inlet Pressure Regulator (See Figure 3, pg. 8).
Caution: Use tie wraps or tubing clamps to secure the connections. The
water pressure may be sufficient to blow the lines off the fittings if they are
not secured.
3. Turn the water supply to the machine ON.
4. With the dialysate lines in the shunt, select Rinse Mode. The pressure
gauge will cycle between two readings as water inlet valve opens and
closes.
Note: Rinse mode causes all valves, pumps, and motors to run/activate.
While in Rinse Mode inspect for any leaks; paying particular attention to
areas of the hydraulics that were disassembled in previous steps during the
preventive maintenance procedures.
FFE
5. Verify that the pressure gauge reads between 18 and 20psi when the
pressure is at its highest value, and reads greater than 8psi when the pressure
is at its lowest value.
Note: Readings below 8psi at the lowest level indicates inadequate inlet
water flow into the machine. This may be caused by a dirty inlet filter
screen or problems with the treated water supply.
6. Turn off the source water supply.
7. Turn the machine OFF, remove the gauge and reconnect the tubing using
clamps to prevent leaks.
8. Turn the treated water supply source ON, turn the machine ON and select
Dialysis Mode. Start dialysate flow and inspect all hoses and connections.
Ensure that there are no leaks.
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Page 34
3.11 ONLINE CLEARANCE TEST (IF APPLICABLE)
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If the machine is equipped with Online Clearance (OLC), conduct the following test:
OLC Self-Test
1. With stable temperature and conductivity, start an OLC Self-Test by
pressing the OLC Self-Test screen button on the Kt/V screen.
TIVE
FFE
Note: Switch to the debug screens by pressing and holding the [
[] keys at the same time for approximately 1 sec. The main display will
change indicating that the machine is in debug mode.
2. When the OLC Self-Test is complete, go to debug screen #5 and confirm that
0 Test (0TST prior to functional software version 3.02) is in the range r20.
Note: If 0 Test (0TST) is out of range, the OLC Self-Test will fail. If
this happens, conduct temperature (PRE & POST) and conductivity
calibrations, then conduct OLC Self-Test again.
OLC Self-Test Troubleshooting
If the OLC Self-Test continues to fail after conducting the temperature (PRE &
POST) and the conductivity calibrations, conduct the following troubleshooting steps:
1. Turn the machine ON and allow the machine to run in Dialysis Mode at
500ml/min flow rate for approximately 10 minutes. This allows the machine to
come up to temperature and conductivity.
Note: On functional software prior to version 3.02, an OLC Self Test will
start automatically as soon as temperature and conductivity are stable. Once
the test starts cancel it by opening the shunt door. The cancel message will
be hidden by the Shunt Door Open banner. Close the shunt door and
confirm that OLC Self Test banner is gone.
] and
2. Once the machine is warmed up, remove X3 (MON-NTC) and X7 (COND)
from the distribution board.
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Page 35
3. Using the Resistor Plug Set for OLC Testing (Fresenius part number 190168),
TPRE
-
=
CPRE
-
=
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plug the 6.04K: plug into X3 (MON-NTC) and the 274: plug into X7
(COND) on the distribution board.
Note: Due to the resistor placement inside the OLC test plugs, the
orientation of the plug when inserted onto the distribution board is irrelevant.
4. Switch to the debug screens by pressing and holding the [] and [] keys at
the same time for approximately 1 sec. The main display will change
indicating that the machine is in debug mode.
5. Use the [] and [] keys to go to debug screen #5.
6. On debug screen #5, locate TPRE and observe its value for 1 minute. During
this time, record the highest and lowest values observed in the table below.
Highest Value Lowest Value Difference
TIVE
FFE
7. Calculate the difference between the highest and lowest TPRE value and
record it in the table above.
8. Verify that the difference for TPRE < 2. If the difference for TPRE > 2, then
possible causes are sensor board, motor noise, or -12V problems.
9. Again on debug screen #5, locate CPRE and observe its value for 1 minute.
During this time record the highest and lowest values observed in the table
below.
Highest Value Lowest Value Difference
10. Calculate the difference between the highest and lowest CPRE value and
record it in the table above.
11. Verify that the difference for CPRE < 8. If the difference for CPRE > 8,
then possible causes are sensor board, motor noise, or -12V problems.
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Page 36
12. Remove the 6.04K: and 274: plug from the distribution board and
TPOS
-
=
CPOS
-
=
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replace the original connectors.
13. Remove X44 (NTC-POST) and X13 (COND-POS) from the distribution
board.
14. Using the Resistor Plug Set for OLC Testing (Fresenius part number
190168), plug the 6.04K: plug into X44 (NTC-POST) and the 274:
plug into X13 (COND-POS) on the distribution board.
15. On debug screen #5, locate TPOS and observe its value for 1 minute.
During this time record the highest and lowest values observed in the
table below.
Highest Value Lowest Value Difference
16. Calculate the difference between the highest and lowest TPOS value and
record it in the table above.
TIVE
FFE
17. Verify that the difference for TPOS < 2. If the difference for TPOS > 2, then
possible causes are sensor board, motor noise, or -12V problems.
18. Again on debug screen #5, locate CPOS and observe its value for 1 minute.
During this time record the highest and lowest values observed in the table
below.
Highest Value Lowest Value Difference
19. Calculate the difference between the highest and lowest CPOS value and
record it in the table above.
20. Verify that the difference for CPOS < 8. If the difference for CPOS > 8, then
possible causes are sensor board, motor noise, or -12V problems.
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Page 37
C
TIVE
P
21. With the 6.04K: plug on X44 (NTC-POST) and the 274: plug on X13
(COND-POS) of the distribution board, verify that CPOS does not change
more then 10 increments when the dialysate flow is turned OFF. (Note:
Conduct this test for the dialysate flow ON to OFF transition.)
22. Remove the 6.04K: and 274: plug from the distribution board and
replace the original connectors.
23. With stable temperature and conductivity, start an OLC Self Test by
pressing the OLC Self-Test screen button on the Kt/V screen.
24. When the OLC Self Test is complete, go to debug screen #5 and confirm that
0 Test (0TST prior to functional software version 3.02) is in the range r20.
FFE
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Page 38
3.12 DEAERATION AND LOADING PRESSURE
atmospheric
Minimum target deaeration
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
C
P
TIVE
Verify that the deaeration pressure is between –24 and -25 inHg and the loading
pressure is between 18 and 20psi (between 23 and 25psi if a DIASAFE
filter
system is installed) as follows:
1. With dialysate flow OFF, install a gauge with a T-fitting to monitor the pressure
on the inlet (suction) side of the deaeration pump (See Figure 3, pg. 8).
2. Connect a gauge equipped with a yellow connector into the red
ACETATE/ACID port.
3. In Dialysis Mode, turn dialysate flow ON and verify that the gauge on the
deaeration pump indicates between -24 and -25 inHg. The needle will be
vibrating somewhat. Verify that it does not go higher than -24 inHg or
lower than -25 Hg. Verify that the gauge in the ACETATE/ACID port
indicates between 18 and 20psi (between 23 and 25psi if a DIASAFE
system is installed).
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:
filter
FFE
Elevation
Approx.
pressure
pressure relative to
atmospheric pressure
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Page 39
3.13 FLOW RELIEF PRESSURE
C
P
TIVE
Verify that the flow relief pressure is between 29 and 30psi (between 35 and 36psi if a
DIASAFE
filter system is installed) as follows:
1. Turn the machine on in Service mode. From the Calibrate Hydraulics
screen, select the Flow Pressure screen button. The screen will change to
the following:
FFE
2. Connect a gauge in line at the output of the flow pump (See Figure 3, pg. 8).
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
3. Press the [CONFIRM] key to start the flow pump.
4. Verify the gauge indicates a pressure between 29 and 30psi (between 35 and
36psi if a DIASAFE
Fresenius 2008®K Preventive Maintenance Procedures
filter system is installed.
P/N 507297 Rev. H
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Page 40
3.14 CONCENTRATE AND BICARB PUMPS
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3.15 UF PUMP
3.16 CONDUCTIVITY
3.17 TEMPERATURE
3.18 VOLT HI LO DETECT
TIVE
Test the Concentrate and Bicarbonate diaphragm pumps as described in Section 4.3.
Calibrate the UF Pump Volume (Refer to the 2008K Calibration Procedures –
Fresenius part number 507296.)
Verify that the dialysate conductivity measured by the internal cell in the machine
agrees with an external meter within 0.1mS/cm as described in Section 2.6.
Verify that the dialysate temperature shown on the front panel Display screen agrees
with an external meter within 0.5qC at 37qC and 39qC as described in Section 2.7
Verify that the 5-volt supply is operating within 0.2 volts as reported on the debug
screen as follows:
FFE
1. Switch to the debug screens by pressing and holding the [
the same time for approximately 1 sec. The main display will change
indicating that the machine is in debug mode.
2. Use the [
3. Locate the 5V value on the display screen. This value must be between
4.8V and 5.2V.
Note: If the 5V value is not within limits, the problem is most likely the
12volt supply out of tolerance. Perform the Volt Hi Lo Detect calibration
procedure. Refer to the 2008K Calibration Procedures – Fresenius part
number 507296.
] and [] keys to go to debug screen #4.
] and [] keys at
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Page 41
3.19 BLOOD LEAK AND DIMNESS
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Verify that the blood leak level is between 4.5 and 5.2 volts and the blood dimness
level is within 5.0 r1.0 volts as follows:
TIVE
1. Switch to the debug screens by pressing and holding the [
the same time for approximately 1 sec. The main display will change
indicating that the machine is in debug mode.
2. Use the [
3. Locate the LEAK value on the display screen. This value must be between
4.5 and 5.2.
4. Locate the DIMN value on the display screen. This value must be between
4.0 and 6.0.
Note: If these values are outside the limits given, perform a bleach rinse
to clean the glass detector tube inside the machine before considering other
repairs.
] and [] keys to go to debug screen #4.
] and [] keys at
FFE
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Page 42
3.20 ARTERIAL, VENOUS AND TRANSMEMBRANE PRESSURE
P
ARTERIAL PRESSURE
1. Inspect the internal pressure transducer protector for contamination. If
contamination is found, replace the pressure transducer protector
(Fresenius part number 650158) and remove and disinfect the pressure
port with 1:100 bleach for a minimum of 15 minutes.
2. Open the arterial transducer port P
on the blood pump module to air
.
ART
(atmospheric pressure). Verify that the Arterial Pressure bargraph indicates 0.
3. Attach a syringe and a calibrated pressure gauge to the P
port using a
.
ART
T-fitting.
4. Push the syringe in to show a pressure of 200mmHg on the external gauge.
Verify that the Arterial Pressure bargraph indicates 200.
5. Switch to the debug screens by pressing and holding the [
] and [] keys at
the same time for approximately 1 sec. The main display will change
indicating that the machine is in debug mode.
6. Use the [
] and [] keys to go to debug screen #1 and locate the ART value.
7. Increase the pressure to a range of 310 – 315mmHg. Clamp off the tubing
at the P
port and monitor the debug ART value for 30 seconds. The
.
ART
maximum allowable leakage is 2mmHg in 30 seconds.
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Page 43
VENOUS PRESSURE
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1. Inspect the internal pressure transducer protector for contamination. If
contamination is found, replace the pressure transducer protector
(Fresenius part number 650158) and remove and disinfect the pressure
port with 1:100 bleach for a minimum of 15 minutes.
TIVE
FFE
2. Open the venous transducer port P
(atmospheric pressure). Verify that the Venous Pressure bargraph
indicates 0.
3. Attach a syringe and a calibrated pressure gauge to the P
T-fitting.
4. Push the syringe plunger in to show 400mmHg on the external pressure
gauge. Verify that the Venous Pressure bargraph indicates 400.
5. Switch to the debug screens by pressing and holding the [
the same time for approximately 1 sec. The main display will change
indicating that the machine is in debug mode.
6. Use the [
7. Decrease the pressure to a range of 310 – 315mmHg. Clamp off the tubing
at the P
maximum allowable leakage is 2mmHg in 30 seconds.
] and [] keys to go to debug screen #1 and locate the VEN value.
port and monitor the debug VEN value for 30 seconds. The
.
VEN
on the level detector module to air
.
VEN
port using a
.
VEN
] and [] keys at
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Page 44
TRANSMEMBRANE PRESSURE
P
1. With dialysate flow ON, ensure the dialysate lines are full of fluid and no
air is visible passing through the flow indicator.
2. Hang a four-way connector to the I.V. pole at normal dialyzer height.
3. Set dialysate flow to 500ml/min, then press the [CONFIRM] key.
4. Open the arterial (P
) and venous (P
.
ART
) transducer ports to air
.
VEN
(atmospheric pressure).
5. Turn the blood pump off.
6. Turn dialysate flow OFF, remove the dialysate lines from the shunt and
attach them to the connector. Close the shunt door.
Note: Filling the lines before removing them from the shunt will avoid
wetting the pressure gauge transducer during the test.
7. Connect a 30cc syringe to one of the four-way connector outlets and a
pressure gauge to the remaining outlet.
8. Switch to the debug screens by pressing and holding the [
] and []keys
at the same time for approximately 1 sec. The main display will change
indicating that the machine is in debug mode.
9. Use the [
] and [] keys to go to debug screen #1.
10. Use the syringe to set the pressure on the external gauge to 0mmHg.
Calculate the dialysate pressure measured by the machine as follows:
x Note the value shown for TMP on the display screen.
x Subtract the value shown for VEN on the display screen.
11. Verify that the calculated value is between +20 and -10mmHg.
12. Use the syringe to create a pressure of -250mmHg on the pressure gauge.
13. Calculate the dialysate pressure measured by the machine again as
described in step 10. Verify that the calculated value is between 230 and -260mmHg.
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3.21 DIALYSATE FLOW
P
Verify the dialysate flow is within r3% of the stated rate at 500ml/min as follows:
Note: All flow rates are controlled by the software. Testing the rate at
500ml/min verifies the accuracy of all rates.
1. In Dialysis Mode, turn the dialysate flow ON at 500ml/min. Verify that the
UF pump is OFF and the machine is out of bypass. Allow the dialysate flow
to run for 2 minutes, minimum, before continuing.
Note: Do not collect the spent dialysate from the drain hose in the next
step. The accuracy of the collection will be affected if not collected directly
from the drain port with the drain hose removed.
2. Collect spent dialysate from the drain port on the back of the machine (See
Figure 3, pg. 8) for exactly 1 minute. Verify that the amount collected is
between 485 and 515ml.
3.22 HEPARIN PUMP
If the machine is equipped with a heparin pump module, clean and test the pump as
follows:
1. Remove the heparin pump module from the machine and wipe the lower
edge of the module and the heparin pump cabinet opening to remove any
residual disinfecting agent.
2. Reinstall the heparin pump into the machine cabinet. When installing the
module screws do not use a power screwdriver
3. Place the machine in Dialysis Mode and clear all alarms.
4. Select the Heparin screen button. On this screen press the Syringe button.
Use the [
the [CONFIRM] key.
5. Press the Load Syringe button. Press the [CONFIRM] key and the carriage
will fully retract downward.
6. When the carriage has stopped, press the [Escape] key and clean the
carriage bar (See Figure 10).
] and [] keys to select the syringe being used for this test and press
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Page 46
SYRINGE BODY HOLDER
CARRIAGE BAR
CARRIAGE / PLUNGER
RELEASE LEVER
PLUNGER HOLDER
CARRIAGE
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7. Extend the syringe plunger past the 10ml mark. Install the syringe into the
pump and latch the plunger handle into the carriage. If needed, squeeze the
carriage/plunger release lever to slide the carriage up to meet the plunger
handle. The syringe plunger should be at a position greater than 10ml.
FFE
Figure 10. Heparin Pump Module.
8. Press the Heparin Prime button. Press and hold the [CONFIRM] key. The
plunger will start moving towards the 10ml mark. Release the [CONFIRM]
key as soon as the syringe plunger is aligned exactly with the 10ml mark on
the side of the syringe body.
9. Select the Bolus data button. Use the [
5.0ml then press the [CONFIRM] key.
10. Select the Total Infused data button. Press the 0 (zero) key and then the
[CONFIRM] key.
11. Press the Infuse Bolus button. Press the [CONFIRM] key and start timing
the interval with the stopwatch.
] and [] keys to set a value of
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Page 47
12. When the pump stops, use the table below to verify the time to run a 5ml
Type
Syringe Size
5ml Bolus Time
B-D
10ml
29.0 – 30.0 seconds
Terumo
10ml (12ml)
24.0 – 25.0 seconds
Monoject
10ml (12ml)
24.5 – 25.5 seconds
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Bolus is correct for the selected syringe type.
13. Also, verify that the Total Infused data button reads 5.0 and that the
syringe plunger has moved to between 4.8 to 5.2 on the syringe scale.
14. Move the carriage all the way up to the end of its travel.
TIVE
FFE
15. Select the RATE data button. Use the [
9.9ml/hr then press the [CONFIRM] key.
16. Press the [Heparin on/off] key to start the pump. The green lamp above
the key should light.
17. Verify that a HEPARIN PUMP ALARM is displayed on the status line
within 2 minutes.
Note: If the machine is not alarm free, another message of higher priority
may be displayed on the status line.
] and [] keys to set a value of
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Page 48
3.23 BLOOD PUMP
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TIVE
Clean and test the arterial blood pump module as follows:
1. Remove the blood pump rotor by opening the door, pulling out the handle
and turning the rotor 90 degrees
2. Clean the rollers with a cloth dampened only with water.
3. With the crank lever pulled out, locate and lubricate the crank lever retainer
ball. If the crank lever is hard to pull out, replace the crank lever retainer
assembly (Fresenius part number 564301).
4. Without removing the plastic sleeve, inspect the solid guide post on all four
(4) tubing guides. The solid guide post should not be loose or bent. If any
of the solid guide posts are loose or bent, the rotor assembly needs to be
replaced. (Fresenius part number M30990).
Note: The plastic sleeve will make it feel like the solid guide post is loose.
When inspecting, pay close attention to the movement of the metal shaft.
5. Clean the inside of the blood pump housing with the damp cloth.
Compressed air may be used if it is available.
6. Remove the blood pump module from the machine and inspect the motor
gearbox. In heavy use, some oil may accumulate on the gearbox housing.
Wipe the housing clean.
FFE
Page 42
7. Wipe the lower edge of the module and the blood pump cabinet opening to
remove any residual disinfecting agent.
8. Reassemble the blood pump module and reinstall it in the machine cabinet.
When installing the module screws do not use a power screwdriver.
9. Place the machine in Dialysis Mode and clear all blood alarms.
10. Start the blood pump if it is not already running.
11. Open the blood pump door. Verify that the red alarm light on the blood
pump module lights within 15 or 30 seconds.
Note: Delay time before the blood pump alarm lights is set by dipswitch 4 on
the LP955 blood pump board.
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Clamp
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12. Close the blood pump door and press the [RESET] key to clear the alarm.
13. Test the pump as follows:
x Set the Tubing Size to 8mm.
x Insert a bloodline in the pump. Do not change the setting of the
tubing size selector, even if you are not using 8mm tubing.
x Connect a pressure gauge to the bloodline in the pump (See
Figure 11) and allow the rotor to pull up 37qC r 1.5qC water. Let
this fluid flow past the pressure gauge long enough to clear out
air.
FFE
Figure 11. Blood Pump Rotor Occlusion Test
x With the pump running at 600ml/min, clamp the outlet so that the
pressure gauge is between the output of the pump and the clamp
(See Figure 11). The peak pressure on the gauge must be between
25 and 35psi. If the peak pressure is out of range, replace the
blood pump rotor springs (Fresenius part number 650174).
x Set the Tubing Size Selector to agree with the size of bloodline
used in the pump.
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3.24 LEVEL DETECTOR
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3.25 ALARM AND PRESSURE HOLDING TESTS
TIVE
Perform the Quarterly Preventive Maintenance procedures in Section 2.8
Perform the Quarterly Preventive Maintenance procedures in Section 2.9.
FFE
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3.26 RINSE CHECKS
P
Perform the Rinse Checks as follows:
1. Place the machine in rinse mode, then turn the water supply off. Verify that
the display screen shows NO WATER.
2. Turn water supply on.
3. Start rinse mode, and watch the flow from the drain line. The water from
the drain line will stop at one point for 15 seconds. At this time put the
drain line in a 1000ml graduated cylinder. Start timing when the flow starts
again. At 30 seconds, remove the line from the graduated cylinder. Verify
that a minimum of 310ml is collected.
4. To avoid problems with pre-rinse, allow the rinse to complete prior to
proceeding to the next step.
5. Connect the dialysate lines to an external meter capable of reading at least
85qC.
6. Close the shunt door.
7. Start the machine in heat disinfect mode with the dialysate lines on the
external meter as follows:
x With the shunt door closed, reach up into the opening at the bottom of the
shunt and find the two spring-loaded switches that protrude through the
holes next to the connectors. Push these switches in with your fingers,
simulating dialysate lines connected to the shunt.
x While holding these switches pushed in, press the Heat Disinfect
button on the startup screen.
x While holding the switches, open the shunt door. Verify the heat
disinfect does not get interrupted.
x Leave the shunt door open; closing it will stop the heat disinfect mode.
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Warning! Scalding hot water is passing through the dialysate lines and the
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external meter manifold. Allow the dialysate lines and the external meter
manifold to cool before disconnecting the lines.
8. The heat disinfect timer will not be operating. It is not needed. Monitor the
external temperature meter and verify that the temperature rises to between
80qC and 90qC.
Note: Some external temperature meters may not display correctly at higher
temperatures. Consult the appropriate product literature from the meter
manufacturer for applicable conversion charts.
3.27 BATTERY AND POWER FAILURE ALARM
Remove the 9-volt battery located behind the monitor unit (See Figure 3, pg. 8). The
battery is inside the plastic housing. Press the cover in and to the left to release it,
then pull it out.
TIVE
FFE
Note: If the 9-volt battery is swollen, the power logic board is bad and should be
replaced.
With the battery removed, perform an Alarm Test and confirm the Battery Test fails.
Note: If the Battery Test passes with the 9-Volt battery removed, IC9 is bad on the
Power Logic Board and should be replaced.
Replace the 9-volt battery with a new one observing the correct polarity marked
inside the holder. Install the battery/holder assembly into the monitor unit.
With the new battery in place, perform an Alarm Test and confirm the Battery Test
passes.
Test the power failure alarm by removing the machine power plug from the wall
outlet with the machine powered on. Verify that the audible alarm sounds.
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3.28 BLOOD PRESSURE MODULE
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TIVE
Note: There are seven types of blood pressure modules that can be connected to the
2008K. Since each module type has different test criteria and the 2008K is unable to
detect which module is connected, disregard the displayed Pass/Fail results and use the
appropriate table to determine pass or fail.
Test the blood pressure module (See Figure 3, pg. 8), as follows:
Place the machine in Service Mode.
Select the Test BP Module button and the screen will change.
INFLATION SPEED TEST
From the Test BP Module screen, select the Inflation Speed button.
1. Connect the pressure tubing from the module to the 700cc port on the Test
Device. Ensure the tubing fits snugly on the ports.
2. Press the [CONFIRM] key. The screen will change and the test will start.
3. The blood pressure module will pressurize the Test Device and report the
time. When the test is complete, use the table below to verify that the Time
to 250 value is within range dependent upon the module type installed.
FFE
Module Type Time to 250
M400 ≤ 7.3 seconds
M2000, M2600 or M3600 ≤ 10.0 seconds
TM-2910 or TM-2915 ≤ 10.0 seconds
SunTech ≤ 11.0 seconds
4. Press the [CONFIRM] key.
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Pressure
Model Type
RATE AT 240
(mmHg/sec)
RATE AT 160
(mmHg/sec)
RATE AT 80
(mmHg/sec)
RATE AT 40
(mmHg/sec)
Min
Max
Min
Max
Min
Max
Min
Max
M400
4.3
6.2
4.6
6.2
3.3
5.2
2.6
4.4
M2000 or M2600
4.4
6.7
4.4
6.7
3.0
5.2
2.4
4.6
M3600
3.8
6.6
3.8
6.6
2.8
5.5
2.3
4.6
TM2910 or TM-2915
3.5
7.5
3.5
7.5
3.5
7.5
3.5
7.5
SunTech
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
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DEFLATION SPEED TEST
Note: The deflation speed test is not applicable to the SunTech module.
From the Test BP Module screen, select the Deflation Speed button.
1. Connect the pressure tubing from the module to the 220cc port on the Test
Device. Ensure the tubing fits snugly on the ports.
2. Press the [CONFIRM] key. The screen will change and the test will start.
3. The blood pressure module will depressurize (deflate) the Test Device. The
screen will change and report the deflation speed at various pressures in mmHg
per second.
4. Use the table below to verify that the values reported are within the
following ranges dependent upon the module type installed.
FFE
Page 48
5. Press the [CONFIRM] key.
AIR LEAKAGE TEST
From the Test BP Module screen, select the Air Leakage button.
1. Connect the pressure tubing from the module to the appropriate module
specific port on the Test Device (see table at the top of the next page).
Ensure the tubing fits snugly on the ports.
2. Press the [CONFIRM] key. The screen will change and the test will start.
3. The blood pressure module will pressurize the Test Device as indicated by a
rise in the Cuff Pressure displayed to approximately 290mmHg. An
internal timer is then activated automatically. Any change in the pressure
being held will show in the Cuff Pressure display.
4. At the end of the Air Leakage test, the pressure is automatically released,
the screen will change and the Leak Rate will be displayed.
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5. Use the table below to verify that the Leak Rate value is within range
Module Type
Test Device Port
Leak Rate
M400, M2000 or M2600
15mmHg
M3600
12mmHg
TM
30mmHg
SunTech
22mmHg
Module Type
Over Pressure Release Range
M400
between 320 and 330mmHg
TM
between 310 and 330mmHg
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dependent upon the module type installed.
TIVE
220cc
220cc
-2910 or TM-2915 700cc
700cc
CALIBRATION CHECK
For the M400 & TM-2910
1. From the Test BP Module screen, select the Calibrate Mode button.
2. Disconnect the pressure tube from the Test Device and connect it to a mercury
manometer or similar pressure meter accurate to within ±1mmHg.
3. Press the [CONFIRM] key. The screen will change and the blood pressure
module will pressurize the line.
4. When the pressure shown on the display screen and on the external meter
stabilizes, verify that they agree within ±3mmHg.
Caution: Do not exceed 330mmHg in the following step. The blood
pressure module may be damaged if this pressure is exceeded.
d
d
d
d
FFE
5. Over Pressure Relief Check:
Remove the hose from the external meter and connect it to a large syringe
(60cc) that has its plunger pulled back. Use the syringe to over-pressurize
the blood test module while watching the display carefully. Use the table
below to verify that the pressure is automatically released within range
dependent upon the module type installed.
-2910
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For the M2000 & SunTech
1. From the Test BP Module screen, select the Calibrate Mode button.
2. Disconnect the pressure tube from the Test Device and connect it to a mercury
manometer or similar pressure meter accurate to within ±1mmHg.
3. Press the [CONFIRM] key. The screen will change and the blood pressure
module will pressurize the line.
4. When the pressure shown on the display screen and on the external meter
stabilizes, verify that they agree within ±3mmHg.
5. Over Pressure Relief Check:
Due to the microprocessor control of the M2000 and SunTech modules, the
over pressure relief check does not need to be conducted. In fact, an over
pressure relief test could permanently damage the module.
For the M2600 & M3600
1. From the Test BP Module screen, select the Air Leakage button.
2. Disconnect the pressure tube from the Test Device and connect it to a mercury
manometer or similar pressure meter accurate to within ±1mmHg.
3. Press the [CONFIRM] key. The screen will change and the blood pressure
module will pressurize the line.
FFE
4. The blood pressure module will pressurize as indicated by a rise in the Cuff
Pressure displayed to approximately 290mmHg. An internal timer is then
activated automatically.
5. When the pressure shown on the display screen and on the external meter
stabilizes, verify that they agree within ±3mmHg.
6. At the end of the Air Leakage test, the pressure is automatically released.
7. Over Pressure Relief Check:
Due to the microprocessor control of the M2600 and M3600, the over
pressure relief check does not need to be conducted. In fact, an over
pressure relief test could permanently damage the module.
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For the TM-2915
1. From the Test BP Module screen, select the Air Leakage button.
2. Disconnect the pressure tube from the Test Device and connect it to a mercury
manometer or similar pressure meter accurate to within 1mmHg.
3. Press the CONFIRM key. The screen will change and the blood pressure
module will pressurize the line.
4. The blood pressure module will pressurize as indicated by a rise in the Cuff
Pressure displayed to approximately 290mmHg. An internal timer is then
activated automatically.
5. When the pressure shown on the display screen and on the external meter
stabilizes, verify that they agree within 3mmHg.
6. At the end of the Air Leakage test, the pressure is automatically released.
7. Press the CONFIRM key.
Caution: Do not exceed 330mmHg in the following step. The blood
pressure module may be damaged if this pressure is exceeded.
Over Pressure Relief Check:
FFE
3.29 FINAL CHECKS
8. Remove the hose from the external meter and connect it to a large syringe
(60cc) that has its plunger pulled back.
9. From the Test BP Module screen, select the Calibrate Mode button.
10. From the first Calibrate Mode screen, press the CONFIRM key.
Use the syringe to over-pressurize the blood pressure module while
watching the display carefully. Verify that the pressure is automatically
released between 310 and 330mmHg.
1. Check the machine for any optional components that are not included here.
Perform the preventive maintenance tests provided with those units.
2. Perform the Quarterly Preventive Maintenance procedures in Section 2.11.
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4.0 REBUILDING THE DIAPHRAGM PUMPS
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4.1 REBUILDING THE ULTRAFILTRATION PUMP
TIVE
The machine contains two types of diaphragm pumps. The ultrafiltration (UF) pump
is a solenoid coil type. The concentrate and bicarbonate pumps are stepper motor
types.
Figure 12 shows an exploded view of the ultrafiltration pump. When working on the
pump, be especially careful to do the following:
x Do not lose the wear button or the shim washers inside the pump solenoid.
x Count the shim washers when you disassemble the pump. The number of
washers varies as needed to mate the solenoid to the pump properly.
Caution: Replace exactly the same number of shims in the ultrafiltration
pump as were removed. The pump will not operate correctly if the same
number of shims are not replaced.
Examine all components for signs of corrosion. Replace any components that
show signs of excessive rust.
FFE
Page 52
Note: If the UF pump does not provide output even though the green light is
on and not flashing, inspect the check valves. If a check valve is installed
backwards, the pump will not work.
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WEAR BUTTON
P
P/N 565219
SHIM
WASHERS
P/N 562343
SEALS
P/N 565279
OUTLET SPRING
P/N 563025
(STRONGER)
O-RINGS
P/N 579058
OUTLET
INLET
SPRING RETAINING CLIP
IS POSITIONED FOR
MAXIMUM COMPRESSION
INLET SPRING
P/N 565278
(WEAKER)
SPACER, P/N 566149
(ON SOME PUMPS THE SPACER
MAY BE MOULDED INTO THE
OUTLET NOZZLE.)
Figure 12. Ultrafiltration Pump Exploded View.
Rebuild the ultrafiltration pump as follows:
1. Remove the UF pump from the machine (See Figure 3, pg. 8). Make a note
of which line goes to which port on the pump. When looking at the end
plate, the arrow pointing into the pump nozzle is the input side. The arrow
pointing away from the pump nozzle is the output side.
2. Hold the two sections of the pump housing and end plate together with one
hand and remove the four long screws from the end plate.
3. Carefully remove the end plate to reveal the input and output nozzles,
springs, seals and O-rings.
4. Replace the inlet and outlet springs.
Caution: Be certain the correct springs are used. The weaker spring goes
on the inlet side. The stronger spring goes on the outlet side.
5. Inspect the seals. Replace them if there is any sign of swelling or wear.
6. Inspect the O-rings. Replace them if there is any sign of wear.
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Note: Before reassembling the UF pump, verify nothing has fallen into the
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solenoid opening.
7. Reassemble the pump as follows:
x The outlet seal goes toward the pump membrane.
x The inlet seal faces away from the pump membrane.
x Reinstall the spacer in the outlet nozzle if one was removed from the
pump.
x Ensure the outlet nozzle is oriented so it will be at the top of the pump
solenoid to help avoid air locks in the pump.
8. Replace the long screws into the end plate and tighten.
9. Replace the pump in the machine and reconnect the electrical and hydraulic
lines. Orient the pump so the outlet nozzle is above the inlet nozzle to help
avoid air locks.
TIVE
FFE
10. To displace air and to check for leaks, start a rinse and allow the machine to
complete the entire rinse cycle.
11. Verify proper function of the UF pump by performing the Quarterly
Preventive Maintenance procedure in Section 2.5.
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4.2 REBUILDING THE CONCENTRATE AND BICARBONATE PUMPS
P
Figure 13 is an exploded view of the concentrate and bicarbonate pumps.
OUTLET SPRING
SEALS
P/N 565279
INLET SPRING
P/N 565278
* ON CONCENTRATE (ACID) PUMPS THIS SPRING
IS STRONGER THAN THE INLET SPRING. USE P/N 563025.
ON BICARBONATE PUMPS USE WEAK SPRINGS
FOR BOTH INLET AND OUTLET (P/N 565278).
ON MACHINES WITH ONLINE CLEARANCE (OLC), THE
CONCENTRATE (ACID) PUMP USES WEAK SPRINGS
FOR BOTH INLET AND OUTLET (P/N 565278).
SEE BELOW *
O-RINGS
P/N 579058
IF THE PUMP CONTAINS A PLASTIC SPACER
IN THE OUTLET PORT, BE SURE TO REPLACE
IT WHEN REASSEMBLING THE PUMP. NEWER
PUMPS HAVE THIS SPACER BUILT INTO THE PORT.
RETAINING PLATE
Figure 13. Concentrate and Bicarbonate Pump Exploded View.
OUTLET
INLET
Rebuild the concentrate pumps as follows:
1. Remove the pump from the machine (See Figure 3, pg. 8). Make a note of
which line goes to which port on the pump. When looking at the end plate,
the arrow pointing into the pump nozzle is the input side. The arrow
pointing away from the pump nozzle is the output side.
2. Hold the two sections of the pump housing and end plate together with one
hand and remove the long screws that hold the end plate. On some models
of the pump, all four screws hold the end plate, and on others only two
screws hold the end plate.
If you removed all four screws to free the end plate, replace one or two of
them to avoid having the pump come completely apart. You only need
access to the inlet seals and springs.
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3. Carefully remove the end plate to reveal the input and output nozzles,
springs, seals and O-rings.
4. Replace the inlet and outlet springs.
Caution: Be certain the correct springs are used on concentrate pumps.
See Figure 13 on previous page.
5. Inspect the seals. Replace them if there is any sign of swelling or wear.
6. Inspect the O-rings. Replace them if there is any sign of wear.
7. Reassemble the pump as follows:
x The outlet seal goes toward the pump membrane.
x The inlet seal faces away from the pump membrane.
x Reinstall the spacer in the outlet nozzle if one was removed from the
pump.
x Ensure the outlet nozzle is oriented so it will be at the top of the pump
solenoid to help avoid air locks in the pump.
8. Replace the long screws into the end plate and tighten.
FFE
9. Replace the pump in the machine and reconnect the electrical and hydraulic
lines. Orient the pump so the outlet nozzle is above the inlet nozzle to help
avoid air locks.
10. To displace air and to check for leaks, start a rinse and allow the machine to
complete the entire rinse cycle.
11. Test the rebuilt diaphragm pump by performing the procedure described in
Section 4.3.
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4.3 TESTING CONCENTRATE AND BICARBONATE PUMPS
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The concentrate (acid) and bicarbonate pumps are tested by measuring the volume of
water they pump and comparing that measurement with the expected value
determined by the machine. The measured pump volume must be within 2% of the
expected value.
Test each pump as follows:
1. Place the machine in Dialysis Mode and clear all alarms.
TIVE
FFE
2. Switch to the debug screens by pressing and holding the [
the same time for approximately 1 sec. The main display will change
indicating that the machine is in debug mode.
3. Use the [] and [] keys to go to debug screen #1.
x Locate the debug value for FILACT. In order to turn off dialysis flow
later, FILACT must be 0.
x Locate the debug value for DOUBLE. Certain types of Bicarbonate or
higher Bicarbonate levels selected will require the pump to double
stroke. If the debug value for DOUBLE is 1, the pump is double
stroking. Before continuing the test, adjust the Bicarbonate level until
the debug value for DOUBLE is 0.
x If the debug values for the Bicarbonate Pump Volume (BMIN and
BMAX) are showing 0 on debug screen #1, the machine is set up for a
concentrate family that does not use bicarbonate. Change the
concentrate selection to one requiring bicarbonate.
Note: The AMIN, AMAX, BMIN, BMAX are the expected limits for
twenty pulses of the acid (concentrate) pump volume and the bicarbonate
pump volume, respectively. These volumes are based on the measured
volume of the balancing chamber to produce the correct mixing ratio.
] and [] keys at
4. Press the [Dialysate Flow on/off] key to stop dialysate flow.
5. Connect a 25ml buret filled with water to the concentrate connector for the
pump to be tested. Use a short length of tubing forced over the end of the
connector, and make sure there are no leaks in the fitting to the connector or
to the buret.
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6. With the machine in Dialysis Mode, press the [Dialysate Flow on/off] key
to start the flow. Observe that liquid is drawn from the buret in discrete
steps. Allow the machine to run and pump fluid from the buret for about 20
strokes, to prime the pump. Press the [Dialysate Flow on/off] key to stop
the flow.
Note: Do not let the buret run dry so that air can enter the system.
7. Refill the buret exactly to the full mark. Press the [Dialysate Flow on/off] key
to start the flow and count exactly 20 pulses of water drawn from the buret,
then stop the flow.
8. Measure the amount of water drawn from the buret carefully to within
0.05ml (within 1/2 division on a buret calibrated in 0.1ml increments).
Verify that this value is between the displayed limits of AMIN and AMAX
for the acid pump volume and BMIN and BMAX for the bicarbonate pump
volume.
9. If a pump volume falls outside of the permitted error, repeat the above
procedure to ensure that you are getting consistent results before recalibrating the machine.
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PREVENTIVE MAINTENANCE CHECKLIST
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QUARTERLY/1000 HOUR
SERIAL NO. _________________________________________________DATE __________________________
MACHINE I.D. NO. ___________________________________________MACHINE HOURS ______________
TECHNICIAN(S) _____________________________________________LABOR HOURS _________________
See the Referenced Section of the Fresenius 2008K Preventive Maintenance Procedures
(Fresenius part number 507297 Rev H) for detailed instructions to perform the following:
Ref. Section Procedure Completed By:
2.1 Clean Filters (replace if necessary) and replace O-Rings:
Water Inlet ................................................................................... _________
Acid and Bicarbonate Connectors ............................................. _________
Dialysate Inline Filter .................................................................. _________
Dialysate Line Connectors .......................................................... _________
Inspect Pre-UF Pump (replace if necessary) ............................. _________
2.2 Replace DIASAFE
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2.3 Inspect UF Pump Check Valves (replace if necessary) ...................... _________
filter (If Applicable) ............................................ _________
2.4 Check High Voltage AC Connections .................................................. _________
2.5 Calibrate UF Pump ............................................................................... _________
2.6 Check Conductivity with External Meter ........................................... _________
2.7 Check Temperature with External Meter ........................................... _________
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2.8 Check and Calibrate Level Detector .................................................... _________
2.9 Check Alarm Operation and Pressure Holding Test ......................... _________
2.10 Check Power Failure Alarm ................................................................. _________
2.11 Inspect Blood Pump Rotor ................................................................... _________
2.12 Final Checks ........................................................................................... _________
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PREVENTIVE MAINTENANCE CHECKLIST
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ANNUAL/4000 HOUR
SERIAL NO. _________________________________________________DATE __________________________
MACHINE I.D. NO. ___________________________________________MACHINE HOURS ______________
TECHNICIAN(S) _____________________________________________LABOR HOURS _________________
See the Referenced Section of the Fresenius 2008K Preventive Maintenance Procedures
(Fresenius part number 507297 Rev H) for detailed instructions to perform the following:
Ref. Section Procedure Completed By:
3.1 Clean Filters and Replace O-Rings ................................................... __________
3.2 Replace Pre-UF Pump Filter ............................................................. __________
3.3 Replace UF Pump Check Valves ....................................................... __________
3.4 Check Deaeration Restrictor and Replace O-Rings ........................ __________
3.5 Replace DIASAFE
3.6 Rebuild UF, Concentrate and Bicarbonate Pumps ......................... __________
3.7 Check Heater Element ....................................................................... __________
3.8 Check High Voltage AC Connections ............................................... __________
3.9 Replace Deaeration Motor Brushes (every 8000 hrs)...................... __________
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3.10 Check Inlet Water Pressure Regulator ............................................ __________
3.11 Conduct Online Clearance Test (If Applicable) .............................. __________
3.12 Check Deaeration and Loading Pressure ......................................... __________
3.13 Check Flow Relief Pressure ............................................................... __________
3.14 Test Concentrate and Bicarbonate Pumps ....................................... __________
3.15 Calibrate UF Pump ............................................................................ __________
3.16 Check Conductivity Calibration ....................................................... __________
3.17 Check Temperature Calibration ....................................................... __________
3.18 Check Volt Hi Lo Detect .................................................................... __________
3.19 Check Blood Leak and Dimness Calibration ................................... __________
3.20 Check Arterial, Venous and TMP Calibration ................................ __________
3.21 Check Dialysate Flow ......................................................................... __________
3.22 Check Heparin Pump (If Present) .................................................... __________
3.23 Check Blood Pump ............................................................................. __________
3.24 Check and Calibrate Level Detector ................................................. __________
3.25 Check Alarm and Pressure Holding Tests ....................................... __________
3.26 Rinse Checks ....................................................................................... __________
3.27 Replace Battery and Check Power Failure Alarm .......................... __________
3.28 Check Blood Pressure Module .......................................................... __________
3.29 Final Checks ........................................................................................ __________
filter (If Applicable) ......................................... __________
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1 Bar
29.53 inHg
1 inHg
25.4 mmHg
1 Psi
51.72 mmHg
1 FLUID OUNCE
26.6 MILLILITERS
1 U.S QUART
0.946 LITERS
1 U.S. GALLON
3.8 LITERS
0.034 FLUID OUNCES
1 MILLILITER
1.057 QUARTS
1 LITER
0.26 U.S. GALLON
1 LITER
1 OUNCE (avdp.)
28.35 GRAMS
1 POUND (avdp.)
0.45 KILOGRAM
0.035 OUNCE (avdp.)
1 GRAM
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COMMON CONVERSIONS
PRESSURE
VOLUME
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Fresenius Medical Care North America
Manufactured by:
Fresenius USA, Inc.
2637 Shadelands Drive
Walnut Creek, CA 94598
800 227-2572
http://www.fmcna.com
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