Copyright 2008 – 2019 F res e ni us Me di c al C ar e, All Rights Reserved.
2008T Preventive Maintenance Procedures
P/N 508033 Rev. M
Page iii
2008T Preventive Maintenance Procedures
This document contains proprietary information of Fresenius USA, Inc. d/b/a Fresenius Medical
Care North America and its affiliates (“Fresenius Medical Care”). The contents of this document
may not be disclosed to third parties, copied, or duplicated in any form, in whole or in part,
without the prior written permission of Fresenius Medical Care.
Fresenius Medical Care, the triangle logo, 2008, BlueStar, bibag and DIASAFE are trademarks
of Fresenius Medical Care Holdings, Inc., or its affiliated companies. All other trademarks are
the property of their respective owners.
Caution: US Federal law restricts this device to sale only by or on the order of a physician.
Frequency, duration, and parameters of treatment are to be determined by the prescribing
physician.
Installation, maintenance, calibration and other technical information may be found in the
2008T Technician’s Manual, P/N 490130.
Contact Fresenius Medical Care Technical Support for applicable Field Service Bulletins. The
spare parts manual for the model 2008T and other information may be found on our web site at
www.fmcna.com
Indications for Use: The 2008T hemodialysis machine is indicated for acute and chronic dialysis
therapy in a healthcare facility.
20kg and ≤ 40 kg). This machine accommodates the use of both low flux and high flux dialyzers.
The SLED therapy option is not to be used for patients weighing ≤ 40 kg. The 2008T
Hemodialysis Machine is not to be used for plasma replacement therapies, for patients weighing
less than 20 kg, or for renal therapies using substitution fluid.
Conventions
Symbol Description
Warning! A warning is a statement that identifies conditions or
actions that could result in personal injury or loss of life.
Warnings found in this manual outside of this section are
designated with the warning symbol.
Shock Hazard: A shock hazard warning refers to a risk of a
possibly severe electrical shock due to improper use or handling
of the equipment.
Caution: A caution is a statement that identifies conditions or
actions that could result in damage to the machine.
Note: Notes are advisory comments or recommendations
regarding practices or procedures.
may result in electrical shock to the operator or patient
Institute of Standards and Technology (National Bureau of Standards)
Improper functioning of the level detector may be caused by a clot of blood.
from that supplied may result in measurement errors.
operating normally.
Refer to the “General Warning” section in the 2008T Hemodialysis Machine Operator’s
Manual (P/N 490122) for a complete listing of general warnings.
Warning! Never perform maintenance when a patient is connected to the machine.
If possible, remove the machine from the treatment area when it is being serviced.
Label the machine to ensure it is not accidentally returned to clinical use before the
service work is completed. Always fully test the machine when maintenance is
completed. Confirm dialysate conductivity and pH level before returning the machine
to clinical use.
Shock Hazard: Refer servicing to qualified personnel. The electrical source must
be 120 volts, 60 Hz, single phase. The outlet must be a three-conductor type with a
hospital-grade receptacle and a ground fault interrupter. Test the polarity and ground
integrity before installation and ensure it is maintained thereafter. Failure to do so
Warning! Calibration procedures must be performed using primary standards or by
using standards that are regularly calibrated in a program traceable to the National
Warning! Calibrate the Level Detector module for the model of venous line being
used. During calibration ensure the filter inside the drip chamber is below the sensor
heads. Also verify that the venous clamp fully occludes the line when closed.
Warning! Failure to install, operate and maintain this equipment according to the
manufacturer’s instructions may cause injury or death to the patient or the operator. If
this equipment is modified, appropriate inspection and testing must be conducted to
ensure continued safe use of the equipment. Substitution of a component different
Warning! Use of this equipment adjacent to or stacked with other equipment should
be avoided because it could result in improper operation. If such use is necessary, this
equipment and the other equipment should be observed to verify that they are
Warning! Only Original Equipment Manufacturer (OEM) Fresenius Medical Care
parts should be used in the repair or upgrade of the Fresenius Medical Care 2008T
Hemodialysis System. Although, parts may look similar to parts in various vendor
catalogs or brick and mortar stores the 2008T Hemodialysis System uses parts that
have been specified and tested in accordance to ANSI/AAMI/ISO guidelines. The use
of non-OEM parts will void your warranty and may cause patient harm.
Note: This document is written for the 2008T Hemodialysis Systems using software
versions 1.04 or later.
2008T Preventive Maintenance Procedures
P/N 508033 Rev. M
Page vi
1.0 INTRODUCTION
Preventive Maintenance for the 2008T Hemodialysis System is simple and straightforward.
Scheduled maintenance is performed based on timed intervals or number of hours a
machine is operated, whichever comes first. The time and hour intervals are as follows:
Machines without Extended Life Pump Components3
• Six (6) months
• Annually or after 4000 hours of operation
Machines with Extended Life Pump Components3
• Six (6) months
• Annually or after 4000 hours of operation
• Concentrate (acid), Bicarbonate & UF Pumps with extended life components3
are rebuilt every 2 years or after 8000 hours of operation.
2008T BlueStar™ Premium Ma chines
2008T BlueStar Premium machine are equipped with extended life components3 and can
be identified by the 2008T BlueStar logo (shown below) on the keyboard.
• Six (6) months
• Annually or after 4000 hours of operation
• Concentrate (acid), Bicarbonate & UF Pumps with extended life components3
are rebuilt every 2 years or after 8000 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.
3
Refer to Sections 4.1 and 4.2 on how to recognize extended life pump components.
2008T Preventive Maintenance Procedures
P/N 508033 Rev. M
Page 1
1.1 SUPPLIES NEEDED
A number of small parts must be available to perform the Preventive Maintenance (PM).
Kits are available that include the necessary parts needed, except for the 9-Volt battery
that must be replaced annually. An NEDA 1604AC heavy-duty (alkaline type) battery is
required.
Machines without Extended Life Pump Components3
o2008T Annual PM Kit (part number 191108)
Machines with Extended Life Pump Components3
o 2008T BlueStar Premium One Year PM Kit (part number 191175)
o 2008T BlueStar Premium Two Year PM Kit (part number 191174)
2008T BlueStar Premium1 Machines
• 2008T BlueStar Premium One Year PM Kit (part number 191175)
• 2008T BlueStar Premium Two Year PM Kit (part number 191174)
Note: The 2008T BlueStar Premium Two Year PM Kit includes all of the
items in the 2008T BlueStar Premium One Year PM Kit along with the
necessary extended life components3 to rebuild the concentrate (acid),
bicarbonate and UF pumps every 2 years or 8000 hours.
1
Refer to Section 1.0 on how to recognize a 2008T BlueStar Pre mium ma chine .
3
Refer to Sections 4.1 and 4.2 on how to recognize extended life pump components.
2008T Preventive Maintenance Procedures
P/N 508033 Rev. M
Page 2
1.2 TEST EQUIPMENT NEEDED
In addition, the following test equipment is needed:
Warning! Test equipment used must be maintained and/or calibrated per the
test equipment manufacturer’s requirements. In particular, the dialysate meter
must meet the specifications listed below. Refer to the test equipment's'
operator's manual, or contact the manufacturer for calibration and maintenance
requirements. Failure to properly maintain and calibrate test equipment could
lead to improper calibration and/or failure of the device to meet its
specifications.
Warning! Disinfect the machine internally and externally and check all
pressure transducer protectors for contamination before working on the
machine.
• 2008T Calibration Procedures (part number 508032).
• Test Kit (part number 150034), which contains two pressure gauges with fittings and
hoses for measuring loading pressure and deaeration pressure.
• Dialysate meter to measure dialysate pressure, temperature and conductivity at the ends
of the dialysate lines. The meter must be capable of making pressure measurements
from -250mmHg to +400mmHg with an accuracy of at least ±3mmHg. The
temperature function of this meter must be accurate within 0.2°C from 20°C to 45°C
and must be capable of measuring dialysate temperatures up to 85°C with an accuracy
of at least ±4.0°C. The conductivity function of this meter must be accurate to within
0.1mS over a range of 12mS to 17mS at a temperature of 25°C.
• Stopwatch with a resolution to 0.01 second and an accuracy of 0.01% or better.
• Buret, 25ml capacity with 0.1ml graduations (part number 290104).
• Graduated cylinder: 1000ml capacity with a tolerance of 5.0ml at 1000ml or better.
• Syringe, 60cc capacity. Tolerance is not important; the syringe is not used for volume
measurements.
• Tubing for Buret tip, 24” long (part number 545325-10). Use on the tip of the Buret.
• Resistor Plug Set for OLC Testing (part number 190168).
The following equipment is also required to test the blood pressure module:
• Dummy Cuff (part number 370090). The Dummy Cuff contains two air chambers with
calibrated volumes.
• Mercury manometer or equivalent pressure meter accurate to within 1mmHg at
pressures up to 330mmHg.
Page 3
2008T Preventive Maintenance Procedures
P/N 508033 Rev. M
1.3 OPERATING MODES
The following preventive maintenance procedures contain instructions to place the
2008T 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.
2008T Preventive Maintenance Procedures
P/N 508033 Rev. M
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1.4 FRONT PANEL CONTROLS
Data Button
The front panel consists of four areas, the display screen, the key pad, a full keyboard
and a touch pad. The display screen is the area under the glass in the center of the
front panel. The key pad is to the right of the display screen and contains membrane
keys. Note the keyboard and touch pad fold down 90 degrees from under the display
screen and key pad.
Throughout the preventive maintenance procedures, whenever a 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 touch pad should be pressed.
Touch Pad Operation
The touch pad is designed to allow the user to move an arrow around on the display
screen. To select a button during a procedure, use the touch pad to move the arrow
over the button on the screen. Tap the touch pad to select the on screen button.
Depending on the type of button, the screen will change. Data boxes are also
displayed on the display screen. The following describes the type of buttons and data
boxes that will be encountered during the preventive maintenance process.
A yellow data button is used to enter a measured volume or
value. When the yellow area of the data button is selected,
it will change to a darker yellow. The data can be changed
using the [▲] and [▼] keys or the value can be entered using
the number keys. Once the data is entered, press the
[CONFIRM] key and the data button changes back to light
yellow. The [Escape] key can be pressed when the data
button is dark yellow to abort the data entry and return it to
light yellow. The entered data does not get stored until the
[CONFIRM] key is pressed.
Some data buttons will change the screen and the data entry
will be performed on the new screen.
A gray data button means the button is not active and
selecting it will have no effect.
2008T Preventive Maintenance Procedures
P/N 508033 Rev. M
Page 5
Screen Button
Blue rectangles on the display screen are screen buttons. By
Data Box
selecting 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.
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.
2008T Preventive Maintenance Procedures
P/N 508033 Rev. M
Page 6
1.5 MEASURING FLUID VOLUMES
BOTTOM OF
MENISCUS
CURVE
Several of the following procedures require measuring fluid volumes using graduated
cylinders and laboratory burets. When making these measurements do the following:
• Make certain the container is clean and dry before collecting the fluid to be
measured. Two drops of fluid are approximately 0.1ml, which is enough to
affect the accuracy of critical measurements.
• Ensure that no items such as thermometers or tubing are allowed to come in
contact with the fluid in the graduate. Such items will change the calibration of
the graduate and affect the accuracy of measurements. Both the total volume
indicated and the amount of fluid indicated by each increment on the graduated
scale will be incorrect. For example, if a graduate is calibrated in 1ml
increments, a piece of tubing in contact with the fluid will cause each increment
to be less than 1ml, depending upon the total volume of the tubing that penetrates
into the fluid.
• Surface tension causes the fluid to curve into a meniscus (See Figure 1).
Measure the volume at the bottom of the meniscus curve as shown.
Figure 1. Meniscus Curve.
2008T Preventive Maintenance Procedures
P/N 508033 Rev. M
Page 7
2.0 SIX (6) MONTH PREVENTIVE MAINTENANCE
Perform the following Preventive Maintenance procedures every six (6) months of
machine operation.
Make copies of the Six (6) Month Preventive Maintenance Checklist provided in
the back of this manual and use them to record the maintenance done.
Note: When performing an Annual Preventive Maintenance do not perform
the six (6) month procedures below first. Go directly to Section 3 and perform
the annual procedures described there.
While performing the following procedures, check the floor of the hydraulic unit and
all surfaces for moisture that might indicate a leak. Locate and correct any leaks
detected. Clean the floor of the hydraulic unit so that future leaks will be readily
apparent. Also, check all electrical connectors that can be reached to be sure they are
fully seated and there is no strain on the electrical cables.
2008T Preventive Maintenance Procedures
P/N 508033 Rev. M
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DIALYSATE LI N E
CONN. O-RINGS
P/N M42674
FLOW PUMP
UF PUMP
ADJUSTMENT
BLOOD PRESSURE
INLET PRESSURE
DRAIN PORT
DEAERATION PU M P
9-VOLT BATTERY
STRAIN
HEATER
INLET WATER FILTER
HEATER ELEMENT
P/N 250169
DIALYSATE
REDUNDANT
BICARBONATE PUMP
CONCENTRATE (ACID)
INLINE FILTER
P/N 650113
MODULE
RELIEF
CONNECTIONS
GROUND
REGULATOR
PUMP BEHIND INLET
PRESSURE REGULATOR
OUTLET
P/N 330636
INLET
Figure 2. 2008T Hemodialysis System, Rear View.
2008T Preventive Maintenance Procedures
P/N 508033 Rev. M
Page 9
2.1 FILTERS
FILTER INSERT P/N 566307
Clean filters as follows. Replace any filters that appear damaged or corroded.
1. Inlet Water Filter in the inlet connector of the water supply (See Figure 2, pg. 9).
2. Filters in the concentrate (acid) and bicarbonate connectors (See Figure 3).
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.
Figure 3. Concentrate (acid) and Bicarbon ate Connector Assemblies.
3. Clean the Dialysate Inline filter (See Figure 2, pg. 9).
2.2 PRE-UF PUMP FILTER
Inspect the Pre-UF Pump filter for leaks or distortion. Replace the Pre-UF Pump Filter
if leakage or distortion is found.
Caution: Do not attempt to disassemble the Pre-UF Pump Filter. If not
properly reassembled, the Pre-UF Pump filter may leak. A leak in the
hydraulic system at this location may affect the operation of the machine or
cause fluid loss from the patient.
2008T Preventive Maintenance Procedures
P/N 508033 Rev. M
Page 10
2.3 UF PUMP CHECK VALVES
Caution: If a check valve is replaced, ensure it is oriented correctly to allow
fluid flow in the proper direction.
Inspect the UF pump Output check valves (one at the UF pump output and the other
downstream at the UF Sample Port). Replace any that show signs of wear, damage
or leaking.
2.4 HIGH VOLTAGE AC CONNECTIONS
Shock Hazard: Dangerous high voltage is present at the connections
accessed in this procedure when the machine is operating. Ensure the
machine's power plug is disconnected from the wall outlet before proceeding.
1. Remove power from the machine then check and tighten the 8-pin heater
connections next to the distribution board (See Figure 2, pg. 9). Check
heater block AC connections for signs of arcing or melting.
2. If applicable, inspect the power plug for loose or frayed wires. Ensure the
strain relief is securely fastened.
3. Inspect the entire length of the power cord (from plug to strain relief) for
nicks or cuts in the insulation and replace if necessary (part number
150425).
4. Confirm that the strain relief is tightly secured to the power supply chassis.
5. At the strain relief, locate the black, white and green wires from the power
cord (inside the power supply chassis). Follow the black and white wires to
the main power switch. Attached to the main power switch are four (4)
wires (2 black and 2 white). Look for loose connections, cracked insulation,
and signs of overheating, such as discolored or melted insulation. Replace
wires with Power Supply Wire Kit (part number 190411).
6. Inspect the main power switch and verify that its operation is smooth (no
grinding or sticky operation) and that the wires are not crossed.
2008T Preventive Maintenance Procedures
P/N 508033 Rev. M
Page 11
Shock Hazard: Do not operate the machine if the resistance is greater than
0.2 ohm. A shock hazard to operators and patients could exist.
7. With a digital multimeter, measure the resistance between the round
(ground) pin on the power plug and the redundant ground terminal on the
machine (See Figure 2, pg. 9). 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.
8. Record the measured value on either the Six (6) Month Preventive
Maintenance Checklist or the Annual/4000 Hour Preventive Maintenance
Checklist depending upon which is being performed.
9. Perform the electrical safety checks required by local codes, facility
procedure and the Joint Commission on Accreditation of Healthcare
Organizations.
2.5 UF PUMP
Calibrate the UF Pump Volume (Refer to the 2008T Calibration Procedures – part
number 508032.)
Record the measured value on the Six (6) Month Preventive Maintenance Checklist.
2.6 CONDUCTIVITY
Verify that the dialysate conductivity measured by the internal cell in the machine
agrees with an external conductivity meter within 0.1mS/cm and within 0.4mS/cm of
TCD as follows:
1. Connect an external conductivity meter to the dialysate lines.
2. With the machine in Dialysis Mode and flow ON, compare the value shown
on the external conductivity meter with the conductivity shown on the
Display screen. They must be within 0.1mS/cm of each other.
3. With the machine in Dialysis Mode and flow ON, compare the value shown
for TCD with the conductivity shown on the Display screen. They must be
within 0.4mS/cm of each other.
4. Record the measured value on either the Six (6) Month Preventive
Maintenance Checklist or the Annual/4000 Hour Preventive Maintenance
Checklist depending upon which is being performed.
2008T Preventive Maintenance Procedures
P/N 508033 Rev. M
Page 12
2.7 TEMPERATURE
Verify that the actual dialysate temperature measured by an external temperature
meter agrees with the display screen within 0.3°C at 37°C and 39°C as follows:
1. Connect the dialysate lines to an external temperature meter.
2. Place the machine in Dialysis Mode with concentrate (acid) in the system.
Clear any alarms.
3. Select2 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 temperature meter connected to the dialysate lines. The two
readings must be within 0.3°C of each other.
5. Record the measured value on either the Six (6) Month Preventive
Maintenance Checklist or the Annual/4000 Hour Preventive Maintenance
Checklist depending upon which is being performed.
6. Repeat steps 3 and 4 with the temperature set to 39.0°C. Verify that the
actual temperature reported on the front panel display screen and the
external temperature meter is within 0.3°C of each other after the
temperatures stabilize again.
7. Record the measured values on either the Six (6) Month Preventive
Maintenance Checklist or the Annual/4000 Hour Preventive Maintenance
Checklist depending upon which is being performed.
2
Refer to Section 1.4 on the use of screen buttons.
2008T Preventive Maintenance Procedures
P/N 508033 Rev. M
Page 13
2.8 ALARM OPERATION AND PRESSURE HOLDING TE STS
For 2008T BlueStar Premium1 machines, this is an optional test.
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. Select2 the Test & Options button. On this screen select2 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.
1
Refer to Section 1.0 on how to recognize a 2008T BlueStar Pre mium ma chine .
2
Refer to Section 1.4 on the use of screen buttons.
2008T Preventive Maintenance Procedures
P/N 508033 Rev. M
Page 14
Table 1. Alarm Tests.
ALARM TEST RESPONSE
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 22Ω.
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. Machine in Bypass mode (no flow through the
dialysate flow indicator).
1. Red visual alarm
2. Yellow visual bypass
3. Machine in Bypass mode (no flow through the
dialysate flow indicator).
Page 15
2008T Preventive Maintenance Procedures
P/N 508033 Rev. M
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