Fresenius Medical Care 2008T BlueStar User manual

Quick Start Guide

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Indications for Use:
2008T Hemodialysis Machine: The 2008T hemodialysis
machine is indicated for acute and chronic dialysis therapy.
bi b ag®System (Optional): The bibag system is used with
three stream proportioning hemodialysis systems equipped
with the bibag module such as the 2008T Hemodialysis
Machine and is intended for use in bicarbonate hemodialysis
for acute and chronic renal failure. The bibag is intended
for extracorporeal bicarbonate hemodialysis according to a
physician’s prescription.
Crit-Line®Clip Monitor (CLiC™) (Optional): The
Crit-Line Clip Monitor is used with the 2008T Hemodialysis
Machine to non-invasively measure hematocrit, oxygen
saturation and percent change in blood volume. The CLiC
device measures hematocrit, percent change in blood volume
and oxygen saturation in real time for application in the
treatment of dialysis patients with the intended purpose of
providing a more effective treatment for both the dialysis
patient and the clinician. Based on the data that the monitor
provides, the clinician/nurse, under physician direction,
intervenes (i.e., increases or decreases the rate at which uid
is removed from the blood) in order to remove the maximum
amount of uid from the dialysis patient without the patient
experiencing the common complications of dialysis which
include nausea, cramping and vomiting.
This 2008T Hemodialysis Machine Quick Start Guide is
intended to be a supplement to the 2008T Operator’s
Manual (P/N 490122) for single-use. Operators must read
and understand the Operator’s Manual supplied with the
equipment. Attention must be given to all “Warning” and
“Caution” statements in the Operator’s Manual

Notes
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WARNING!
Failure to operate and maintain the machine
according to the manufacturer’s instructions may
cause operator or patient injury or death.
WARNING!
To maintain sterility of the blood pathway, do not
allow the ends of the bloodlines to come in contact
with non-sterile solutions or surfaces which may
contaminate the blood pathway.
Note: To conrm a changed parameter, do any of
the following:
• Double-click the touchpad.
• Press the Conrm key.
• Press either of the Enter keys on the keyboard.
Caution: Federal (US) law restricts this device to sale by
or on the order of a physician.
Note: Read the Instructions for Use for safe and proper
use of this device. For a complete description of hazards,
contraindications, side effects, and precautions, see full
package labeling available at www.fmcna.com.

1. Press the Power key on the control panel. The Select
Program screen will then appear on the monitor.
2. Flip down the touchpad and/or the keyboard.
3. Plug the acid (red) concentrate connector into the
acid source.
4. Select the Dialysis button, the Dialysate screen will
appear on the monitor.
5. Conrm the concentrate. If the concentrate must be changed,
select the CONC button, enter the concentrate type using
the Up or Down Keys on the keyboard, then press Conrm.
6. Select the Base Na+ and Bicarbonate buttons, enter the
prescribed value using the data entry keys, and then press
Conrm.
7. Select the Home button. The Home screen will appear
on the monitor (Air Detector alarm will be displayed in
the Status Box).
8. Plug the biocarbonate (blue) concentrate connector into
the bicarbonate source.
Note: If the bibag disposable is the bicarbonate source, do not
pull the blue bicarbonate connector from the machine’s rinse
port. Do the following to prepare the bibag disposable:
1. Remove the plastic seal from underneath the water and
bicarbonate nozzles of the bibag disposable.
2. Open the bibag door on the machine by lifting up on
the dark gray handle.
Set Up Concentrate
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3. With the white bibag handle facing out (the blue
labeling should be facing you), hang the bag on the
bibag connector nozzles.
4. Close the door, making sure it latches rmly in place.
You will hear an audible click indicating the door is closed.
5. When the machine is ready, (water is at the minimum
temperature and no air in the hydraulics), the bag will
ll with heated water to be used as a bicarbonate
concentrate for dialysate production.
Note:
1. Dialysate ow must be on in order to ll the bag.
2. The bibag disposable contains a xed amount of
bicarbonate powder. Refer to the bibag Estimated
Run Time Reference Card (P/N 101746-01 or P/N
102768-01) to verify that enough run time is available
to complete a treatment.
3. Do not remove the blue bicarbonate connector from
the machine’s bicarbonate port while using the bibag
system for treatment. Doing so will stop the ow to
and from the bibag disposable.
4. The bibag disposable must hang freely below the bibag
connector. Make certain that there are no jugs or other
objects obstructing or touching the bibag disposable.

WARNING!
Acid concentrate products are used as one
component in mixing dialysate bath.These acid
products contain chemical compounds that,
after mixing, yield acetate (and citrate in certain
products) in the dialysate. (Please refer to the acid
concentrate product labeling for specic acetate/
citrate amounts.) After diffusion across the dialyzer
membrane, acetate (and citrate when present) is
metabolized by the liver to serum bicarbonate and
adds to the serum bicarbonate that separately results
from the diffusion of dialysate bicarbonate across
the dialyzer membrane. During dialysis, the dynamic
of diffusion and concentration gradients prevent
serum bicarbonate concentration from exceeding the
dialysate bicarbonate concentration.The bicarbonate
concentration of the dialysate is the “bicarbonate”
setting on the dialysis machine, and is the bicarbonate
dose prescribed by the physician. On the 2008®series
hemodialysis machines, the bicarbonate dose may
be set in a range between 20 and 40 milliequivalents
per liter, but may be set in different range in the
other machines.
Setup Concentrate (continued)
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When the dialysis session terminates, acetate (and
citrate when present) that has not yet metabolized
may remain in the blood and will be converted to
serum bicarbonate after diffusion ceases, without
possibility of diffusion out of the blood.The
post dialysis metabolism of acetate (and citrate
when present) could thus briey increase serum
bicarbonate concentration above the prescribed
bicarbonate concentration of the dialysate. Physicians
should consider this possibility in prescribing
bicarbonate dose.
Prescription of insufcient bicarbonate may
contribute to metabolic acidosis; excessive
bicarbonate may contribute to metabolic alkalosis.
Both conditions are associated with poor patient
outcomes, including increased mortality risk.

Setting-up Bloodlines and Priming
Extracorporeal Circuit
Follow facility’s policy and procedure guidelines for setting
up bloodlines and priming the extracorporeal circuit.
Note: Policies and procedures should include the
manufacturer’s recommendation for use, including dialysis
machine, bloodline, and blood chamber (if Crit-Line®
technology is used), dialyzer and saline.
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1. To run the tests, verify:
a. Dialysate lines are on the shunt interlock with the
interlock door closed.
b.The machine is alarm-free.
c. Arterial and venous pressure monitor lines are
clamped and disconnected so the pressure ports
are open to the atmosphere.
d. UF and SVS are off.
2. Select the Test & Options button.
3. Select and conrm the Both Tests button to begin
running the pressure and alarm tests.
4. When the message “Test Complete” is displayed in
the status box, press Reset to clear the message.
Pressure and Alarm Tests
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Recirculation
1. If applicable, based on the specic bloodline and dialyzer
being used, rotate the dialyzer so the arterial (red) inlet is up.
2. Check the conductivity and the pH of the dialysate and test
for residual disinfectant, if applicable, before connecting the
dialysate lines to the dialyzer.
WARNING!
Always verify the conductivity and approximate
pH of the dialysate solution through independent
means (e.g. using a conductivity meter or pH paper
or meter, as applicable) before initiating each dialysis
treatment. Verify that the conductivity is reasonably
close to the theoretical conductivity value (TCD) and
the pH is between 6.9 and 7.6. If they are not, do not
initiate dialysis.
3. Connect the dialysate lines to the dialyzer by matching the
color of the dialyzer connector to the color of the blood
tube tting (red-red and blue-blue), and then close the
shunt door. Pull on the dialyzer connectors to make sure
they are rmly connected to the dialyzer.
4. Connect the arterial and venous pressure monitor lines
to their respective pressure ports, and then unclamp
the lines.

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5. When the dialysate compartment is lled, rotate the
dialyzer so the arterial (red) inlet is down.
6. After priming the extracorporeal blood circuit, press Reset
to clear all alarms. Set the blood pump per facility’s policy
to begin recirculating saline through the circuit.
7. Press the Down Arrow on the level detector module to
lower the uid level in the drip chamber. Verify that the
blood pump stops and the venous clamp occludes.
8. Check blood tubing to ensure there are no kinks.
9. Replace saline bag with a fresh bag, if necessary.
10. Check for a normal dialysate ow by watching the oat
in the dialysate line.The oat should drop four times in
about 15 seconds for a 500 ml/min ow, or four times
in 10 seconds for an 800 ml/min ow.
11. Open the shunt door to verify the machine goes into
Bypass Mode. In Bypass Mode, the oat in the ow
indicator of the dialyzer supply line should drop and
remain at the bottom of the indicator and an audible
alarm may sound.
12. Close the shunt door again.
13. Set treatment parameters as prescribed.
Note: If Prime/Recirc option selected, wait until Recirc
is done before entering parameters.

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Starting Dialysis
1. Complete patient assessment per unit policy
and procedures.
2. Wrap blood pressure cuff around the patient’s
non-access arm.
3. If the CLiC™ device will be used for this treatment, clip
the CLiC device on the Crit-Line blood chamber at this
time. For more information, see the “2008T Hemodialysis
Machine with CLiC User’s Guide” (P/N 490206).
4. Verify that ultraltration is off (UF light is off), and that the
UF Removed button is reset to zero.The UF Removed
button may be reset by selecting UF Removed button,
and then the zero key and conrm the change.
5. Verify the venous line is in the venous clamp and the
optical detector door is closed.
WARNING!
Do not infuse the recirculated saline prime into
the patient. Discard the recirculated saline and ll
the extracorporeal circuit with fresh saline prior to
connecting to the patient. The volume of fresh saline
that is used to ll the extracorporeal circuit should
be equal to the volume of the dialyzer and blood
tubing set in use.

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6. Lower the blood pump rate to the “Facility’s Initiation
of Treatment Policy and Procedures” and press the
Start/Stop key to stop the blood pump.
7. Connect the arterial and venous bloodlines to patient’s
access and initiate treatment per the unit’s protocol.
WARNING!
Check all bloodline and dialysate line connections
for uid leaks. Keep access sites uncovered and
monitored. Improper bloodlines connections or
needle dislodgements can result in excessive blood
loss, serious injury, and death. Machine alarms may
not occur in blood loss situation.
8. Press the Start/Stop key to start blood pump
and set QB and QD to prescribed rates.
9. Rotate the dialyzer to arterial (red) end up.
10. Select the TX Clock button when the status box turns
yellow and press Conrm to start the treatment.
The status box will now show “Dialysis.”
11. Check that UF/SVS/Heparin are on, if prescribed.
Check that the Crit-Line device is attached to the
Crit-Line blood chamber, if prescribed. If applicable,
a blood pressure measurement is initiated.

1. Press Reset to clear any alarms.
2. Select the TX Clock and press Conrm to stop the
treatment.The status box will now show “Dialysis Paused.”
3. Press the Start/Stop key on the blood pump to stop
the pump.
4. Replace saline bag with a fresh bag, if necessary.
5. Rinse the blood in the extracorporeal circuit back to the
patient utilizing the “Facility’s Termination of Treatment
Policy and Procedures.”
6. Clamp the arterial and venous bloodlines and the
patient’s arterial and venous access lines and aseptically
disconnect them.
Note: If applicable, the following procedure may be
done utilizing “Facility Policies and Procedures.”
Note: If the bibag disposable was used for the treatment, go
to the Dialysate Screen and select “Empty bibag” and conrm.
Once the bibag is empty, proceed to emptying the dialyzer.
The bibag disposable and the dialyzer cannot be emptied at
the same time.To run the Empty bibag program, both dialysate
lines must either be on the shunt or on the dialyzer.
For Single-Use Dialyzers:
7. Open shunt interlock door.
8. Return blue dialyzer connector to shunt interlock. Pull on
the dialyzer connector to make sure it is rmly connected
to the shunt.
9. Reposition the dialyzer so that the red outlet port is at
the bottom.
Completion of Dialysis
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10. Close the shunt interlock door. Message “Emptying” will
be displayed.
11. Drain the dialysate compartment. The dialyzer is empty
as soon as there is air in the outlet line or an “Emptying
stopped” message appears.
12. Open the shunt interlock door, remove red dialyzer
connector from the dialyzer and place it on the shunt.
Pull on the dialyzer connector to make sure it is rmly
connected to the shunt. Close the shunt interlock door.
13. Discard the bloodlines, transducer protectors, and dialyzer
according to facility policy.
14. Insert the concentrate wands into their proper rinse ports.
The “Select Program” screen appears on the display screen.
15. Clean or disinfect the exterior of the machine according
to routine cleaning and maintenance procedures described
in “Disinfection and Maintenance,” on page 136.
16 . If there is another patient:
• Press the newTX key and then Conrm.
• The treatment parameters will be reset to the default
settings. The sodium, bicarbonate, and concentrate
type will maintain the previous TX settings.
17 . If there is not another patient:
• Return acid and bicarbonate (if used) connectors to
their respective ports, and then proceed with cleaning
and disinfecting.
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1. To run the cleansing/disinfecting programs, verify:
• Dialysate lines are securely on the shunt.
• Acid and bicarbonate connectors are securely
inserted into their respective ports.
2. After the last treatment of the day, select the Acid
Clean and Heat Disinfect button on the Select
Program screen and press Conrm.
3. When prompted, connect acid (red) and bicarbonate
(blue) connectors to jug containing acid cleaner.
4. Press Conrm to start the Acid Clean portion of
the program.
5. When completed, the message “Put Connectors in
ports” will appear. Put acid and bicarbonate connectors
securely into the respective machine ports.
WARNING!
During the heat disinfection cycle, it is not
uncommon to see steam emitting from the vent
tubing at the back of the machine. This steam may
cause burns if contacted. Also, the temperature of
the dialysate lines and drain line can get as hot as
69°C (156°F). Please use care.
WARNING!
Do not open the bibag door during a heat
disinfection as serious injury may occur. Keep
Acid Clean & Heat Disinfection
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the bibag door closed when running any rinse or
disinfection program.
6. The “Heat Disinfect” screen appears next in the display.
The machine will automatically run a short rinse (seven
minutes standard or ten minutes with DIASAFE®Plus)
or extended rinse (twenty minutes) depending how the
machine was congured in Service Mode.
7. After the heat disinfection is complete, if the machine is
not congured to automatically turn off at the completion
of the cycle, press Conrm to exit when prompted.
Note:
• If the machine is not congured to automatically turn
off at the completion of the heat cycle, press Conrm
to exit when prompted. Press and hold the Power key
to turn off the machine.
• If acid cleaning is not needed, select the Heat
Disinfection button on the Select Program screen
and press Conrm to start the Heat Disinfection
program. When the program is complete, the machine
should turn off automatically (see note above).
• If the Auto Heat Disinfection service option is set:
o After completion of the Acid Clean, leave the
machine on the Select Program screen. The Heat
Disinfect program will run at the scheduled time.
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1. To run the Cleaning/Disinfecting programs, verify:
• Dialysate lines are securely on the shunt.
• Acid and bicarbonate connectors are securely
inserted into the respective machine ports.
2. After the last treatment of the day, select the Acid Clean
button on the Select Program screen and press Conrm.
The lines will be rinsed.
3. When prompted, connect acid (red) and bicarbonate (blue)
connectors to a jug containing acid cleaner.
4. Press Conrm to start.
5. When the Acid Clean program is completed, the message
“Put Connectors in Ports” will appear. Put acid and
bicarbonate connectors securely into their respective
ports and press Conrm to exit.
6. Select the Chemical/Rinse button on the Select Program
screen and press Conrm. The lines will be rinsed.
Note: If the “HE Leak Test” Service Mode option is selected
(software versions 2.53 and later), the machine will run a four
minute pressure holding test after the 45 second pre-rinse. If
the rst test fails, a second test will automatically run.
If the second test fails, the machine will display a “System
Leak, Can’t Run” message, meaning that the Chemical/Rinse
program can no longer be run due to a leak detected in the
Acid Clean & Chemical Rinse
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Heat Exchanger. However, the machine will still be able to run
Heat Disinfection programs and hemodialysis treatments per
unit protocol. Call a qualied service technician.
7. When prompted, connect the red acid connector to a jug
containing chemical disinfectant and press Conrm.
8. Water pre-rinse will start. Remaining pre-rinse time meter
box will count down. When the remaining pre-rinse time
meter box reads 0:00, chemical rinse will start after a
delay. Remaining time meter box will count down.
9. When the remaining time meter box reads 0:00, remove
the red acid connector from the disinfectant jug and
insert it into the acid rinse port when prompted. Post
rinse will start, and remaining post rinse time meter
box counts down.
10. Press Conrm to exit.
WARNING!
Test for residual disinfectant prior to starting treatment
following a chemical disinfection.
Note: The machine will automatically perform a DIASAFE
test after the chemical rinse program completes. When
the message “DIASAFE Test Passed” is displayed, press
the Reset key to clear the advisory. Then, press Conrm
to exit.
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© 2010 - 2017, Fresenius Medical Care, All Rights Reserved. Fresenius Medical Care, the triangle logo, Fresenius Renal Technologies, 2008,
bi b ag, Crit-Line, CLiC, and DIASAFE are trademarks of Fresenius Medical Care Holdings, Inc. or its afliated companies. All other
trademarks are the property of their respective owners. P/N 490161 Rev D 09/2017
Fresenius Renal Technologies
A Division of Fresenius Medical Care North America
920 Winter Street | Waltham, MA 02451
Clinical and Technical Support
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