Fresenius Medical Care DIASAFE 2008 K Guide

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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
HEMODIALYSIS SYSTEM
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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Fresenius 2008®K Preventive Maintenance Procedures
P/N 507297 Rev. H
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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Fresenius 2008®K Preventive Maintenance Procedures
P/N 507297 Rev. H
PREVENTIVE MAINTENANCE PROCEDURES
TABLE OF CONTENTS
1.0 INTRODUCTION............................................................................................................................................1
1.1 TEST EQUIPMENT AND SUPPLIES NEEDED.............................................................................................1
1.2 OPERATING MODES ....................................................................................................................................3
1.3 FRONT PANEL CONTROLS.........................................................................................................................4
1.4 MEASURING FLUID VOLUMES ...................................................................................................................6
2.0 QUARTERLY (1000 HOUR) PREVENTIVE MAINTENANCE .......................................................................7
2.1 FILTERS AND O-RINGS ............................................................................................................................ 9
2.2 DIASAFEFILTER (IF APPLICABLE) ...................................................................................................... 10
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
3.0 ANNUAL (4000 HOUR) PREVENTIVE MAINTENANCE ............................................................................ 23
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FILTER (IF APPLICABLE) ...................................................................................................... 24
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 ...................................................................................................................................... 45
3.27 BATTERY AND POWER FAILURE ALARM.............................................................................................. 46
3.28 BLOOD PRESSURE MODULE ................................................................................................................ 47
3.29 FINAL CHECKS ....................................................................................................................................... 51
4.0 REBUILDING THE DIAPHRAGM PUMPS ..................................................................................................52
4.1 REBUILDING THE ULTRAFILTRATION PUMP........................................................................................ 52
4.2 REBUILDING THE CONCENTRATE AND BICARBONATE PUMPS ........................................................ 55
4.3 TESTING CONCENTRATE AND BICARBONATE PUMPS ...................................................................... 57
PREVENTIVE MAINTENANCE CHECKLIST QUARTERLY/1000 HOUR........................................................... 61
PREVENTIVE MAINTENANCE CHECKLIST ANNUAL/4000 HOUR..................................................................63
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Fresenius 2008®K Preventive Maintenance Procedures
P/N 507297 Rev. H
NOTE
This document is written for Fresenius 2008K
Hemodialysis Systems using software versions
2.16 or later.
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Fresenius 2008®K Preventive Maintenance Procedures
P/N 507297 Rev. H
1.0 INTRODUCTION
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 re-
calibrate as needed, then repeat the tests until the specifications are met before
returning the machine to service.
Checklists are provided in the back of this manual to record the work done. Make
copies of these checklists as needed. Your initials on the checklist certifies that each
procedure has been completed and that the machine is performing according to the
specifications given.
1.1 TEST EQUIPMENT AND SUPPLIES NEEDED
A number of small parts must be available to perform the Preventive Maintenance.
Fresenius part number 190098 is a kit of the parts needed, except for the 9-Volt
battery that must be replaced during the annual preventive maintenance. An NEDA
1604AC heavy-duty (alkaline type) battery is required. In addition, the following
test equipment is needed:
Warning! All of the test equipment used must be maintained and calibrated
regularly in accordance with NIST standards. In particular, the conductivity meter
must meet the specifications given below. Failure to do so could result in injury or
death to the patient or to the operator.
Warning! Disinfect the machine internally and externally and check all pressure
transducer protectors for contamination before working on the machine.
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xFresenius Test Kit (Fresenius part number 150034), which contains two gauges
with fittings and hoses for measuring loading pressure and deaeration pressure.
xDialysate meter to measure dialysate pressure, temperature and conductivity at
the ends of the dialysate lines. The meter must be capable of making pressure
measurements from -250mmHg to +400mmHg with an accuracy of at least
±3mmHg. The temperature function of this meter must be accurate within
0.2°C from 20°C to 45°C and must be capable of measuring dialysate
temperatures up to 85°C with an accuracy of at least ±4.0°C. The conductivity
function of this meter must be accurate to within 0.1mS over a range of 12mS to
17mS at a temperature of 25°C.
xStopwatch with a resolution to 0.01 second and an accuracy of 0.01% or better.
xFresenius Buret, 25ml capacity with 0.1ml graduations (Fresenius part number
290104).
xGraduated cylinder: 1000ml capacity with a tolerance of 5.0ml at 1000ml or
better.
xSyringe, 60cc capacity. Tolerance is not important; the syringe is not used for
volume measurements.
xTubing, 24” long (Fresenius part number 545325-10). Use on the tip of the
Buret.
xResistor Plug Set for OLC Testing (Fresenius part number 190168).
The following equipment is also required to test the blood pressure module:
xTest Device (Fresenius part number 370090). The Test Device contains two air
chambers with calibrated volumes.
xMercury manometer or equivalent pressure meter accurate to within 1mmHg at
pressures up to 330mmHg.
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Fresenius 2008®K Preventive Maintenance Procedures
P/N 507297 Rev. H
1.2 OPERATING MODES
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
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.
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.
Control Panel
Touch Screen
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P/N 507297 Rev. H
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.
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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1.4 MEASURING FLUID VOLUMES
Several of the following procedures require measuring fluid volumes using
graduated cylinders and laboratory burets. When making these measurements do the
following:
xMake certain the container is clean and dry before collecting the fluid to be
measured. Two drops of fluid are approximately 0.1ml, which is enough to
affect the accuracy of critical measurements.
xEnsure that no items such as thermometers or tubing are allowed to come in
contact with the fluid in the graduate. Such items will change the calibration of
the graduate and affect the accuracy of measurements. Both the total volume
indicated and the amount of fluid indicated by each increment on the graduated
scale will be incorrect. For example, if a graduate is calibrated in 1ml
increments, a piece of tubing in contact with the fluid will cause each increment
to be less than 1ml, depending upon the total volume of the tubing that penetrates
into the fluid.
xSurface tension causes the fluid to curve into a meniscus (See Figure 2).
Measure the volume at the bottom of the meniscus curve as shown.
Figure 2. Meniscus Curve.
BOTTOM OF
MENISCUS
CURVE
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P/N 507297 Rev. H
2.0 QUARTERLY (1000 HOUR) PREVENTIVE MAINTENANCE
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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P/N 507297 Rev. H
Figure 3. Fresenius 2008K Hemodialysis System, Rear View.
DIALYSATE LINE
CONN. O
-
RINGS
P/N 579097
FLOW PUMP
OUTLET
UF PUMP
ADJUSTMENT
BLOOD PRESSURE
MODULE
INLET PRESSURE
REGULATOR
DRAIN PORT
DEAERATION PUMP
INLET
9-VOLT BATTERY
STRAIN
RELIEF
HEATER
CONNECTIONS
INLET WATER FILTER
P/N 330636
HEATER ELEMENT
P/N 250169
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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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.
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.
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.
2.2 DIASAFE

FILTER (IF APPLICABLE)
If the machine is equipped with a DIASAFEor DIASAFEPLUS 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filter integrity test.
Note: If the machine is equipped with a DIASAFEfilter, replace its quick
connector O-rings (Fresenius part number 579097) when replacing the filter.
2.3 CHECK VALVES
Caution: If a check valve is replaced, ensure it is oriented correctly to
allow fluid flow in the proper direction.
Inspect the UF Pump Output check valves (one at the UF pump and the other
downstream at the UF Sample Port). Replace any that show signs of wear, damage
or leaking.
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2.4 HIGH VOLTAGE AC CONNECTIONS
Warning! Dangerous high voltage is present at the connections accessed
in this procedure when the machine is operating. Ensure the machine's
power plug is disconnected from the wall outlet before proceeding.
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
Calibrate the UF Pump Volume (Refer to the 2008K Calibration Procedures –
Fresenius part number 507296.)
2.6 CONDUCTIVITY
Verify that the dialysate conductivity measured by the internal cell in the machine
agrees with an external meter within 0.1mS/cm as follows:
1. Connect an external conductivity meter to the dialysate lines.
2. With the machine in Dialysis Mode and flow ON, compare the value shown
on the external meter with the conductivity shown on the Display screen.
They must be within 0.1mS/cm of each other.
2.7 TEMPERATURE
Verify that the actual dialysate temperature measured by an external meter agrees
with the display screen within 0.5qC at 37qC and 39qC as follows:
1. Connect the dialysate lines to an external meter.
2. Place the machine in Dialysis Mode with concentrate in the system. Clear
any alarms.
3. Select the Temperature button. The button label will change to Temp.
Setting. The value now displayed on this button is the temperature set
point. Adjust the temperature set point to exactly 37.0 then press the
[CONFIRM] key. The button will change back and now reads the actual
temperature of the dialysate again. Wait until this value stabilizes. It will
settle very close to the value set, depending upon inlet water temperature
and other conditions.
4. After the temperature of the dialysate stabilizes, compare the temperature
shown on the Temperature button with the temperature shown on the
external meter connected to the dialysate lines. The two readings must be
within 0.5qof 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 0.5qof each other after the temperatures stabilize again.
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2.8 LEVEL DETECTOR
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
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:
xUse Method 1 if LP450 has LED’s D6 & D19 (See Figure 5)
xUse 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).
xUse 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.
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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