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.