15-0008_2008k2_HandiGuide_MECH_Rd3_Layout 1 2/23/15 9:24 AM Page 1
Contacts
Clinical Support Specialist:
Phone:
Cell Phone: A Quick Start Guide
Email:
Fresenius Renal Technologies
A division of Fresenius Medical Care North America
920 Winter Street
Waltham, MA 02451
Technical Service Customer Service
Phone: 800-227-2572 Phone: 800-323-5188
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.
© 2009, 2014, 2015 Fresenius Medical Care, All Rights Reserved. Fresenius Medical
Care, Fresenius Renal Technologies, the triangle logo, 2008 and DIASAFE are
trademarks of Fresenius Medical Care Holdings, Inc and/or its affiliated companies.
All other trademarks are the property of their respective owners.
P/N 490148 Rev C 02/2015
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Notes Setup Concentrate
NOTE Setup Concentrate:
Indication for Use: The 2008K2 hemodialysis machine 1. Press the POWER key on the control panel. The
is indicated for acute and chronic dialysis therapy. “Select Program” screen will appear on the monitor.
2. Plug the acid (red) concentrate connector into
This 2008K2 Hemodialysis Machine Quick Start Guide is acid concentrate source.
intended to be a supplement to the 2008K2 Hemodialysis 3. Use navigational arrows to highlight “Dialysis”
Machine Operator’s Manual (P/N 490136) using single-use and CONFIRM.
dialyzers and the Prime Amount method of priming. 4. Use navigational arrows to highlight Conc button and
Operators must read and understand the operator’s press CONFIRM, use up/down arrows to choose the
manual supplied with the equipment. Attention must correct acid concentrate and press CONFIRM.
be given to all “Warning” and “Caution” statements 5. Navigate to highlight Base Na+ and Bicarbonate buttons,
in the operator’s manual. enter value with the up/down or data entry keys and CONFIRM.
6. Press Home screen-key. The “Home” screen will appear
WARNING on the monitor (Air Detector alarm will be displayed in
Failure to operate and maintain the machine according to
the manufacturer’s instructions may cause operator or the Status Box).
patient injury or death. 7. Plug the bicarb (blue) concentrate connector into
bicarbonate concentrate source.
WARNING
To maintain sterility of the blood path, do not allow the ends 8. Verify the Dialysate Flow is at least 500 ml/min.
of the bloodlines to come into contact with non-sterile
solutions or surfaces which may contaminate the blood path.
1 2
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Setup Concentrate (continued) Setup Bloodline
WARNING! Arterial Line:
Acid concentrate products are used as one component in mixing 1. Close medication port clamp.
dialysate bath.These acid products contain chemical compounds
that, after mixing, yield acetate (and citrate in certain products) in 2. Snap arterial drip chamber into holder.
the dialysate. (Please refer to the acid concentrate product labeling 3. Connect monitor line to arterial pressure port
for specific acetate/citrate amounts.) After diffusion across the with a transducer protector and verify the line
dialyzer membrane, acetate (and citrate when present) is
metabolized by the liver to serum bicarbonate and adds to the
is unclamped.
serum bicarbonate that separately results from the diffusion of 4. Insert blood pump segment into blood pump and
dialysate bicarbonate across the dialyzer membrane. During dialysis, close door.
the dynamic of diffusion and concentration gradients prevent serum 5. Snap bloodline into red guides on modules.
bicarbonate concentration from exceeding the dialysate bicarbonate
concentration.The bicarbonate concentration of the dialysate is the 6. Aseptically place the patient end of the arterial line
“bicarbonate” setting on the dialysis machine, and is the bicarbonate into priming bucket clip. Snap the dialyzer end of
dose prescribed by the physician. On the 2008 series hemodialysis the arterial line into the dialyzer holder clip.
machines, the bicarbonate dose may be set in a range between 20
and 40 milliequivalents per liter, but may be set in different ranges in
other machines. Venous Line:
1. Close medication port clamp.
When the dialysis session terminates, acetate (and citrate when 2. Roll the venous drip chamber into holder with
present) that has not yet metabolized may remain in the blood and
will be converted to serum bicarbonate after diffusion ceases, filter below sensor heads; close and latch door.
without possibility of diffusion out of the blood.The post dialysis 3. Connect monitor line to pressure port with
metabolism of acetate (and citrate when present) could thus briefly a transducer protector and verify the line
increase serum bicarbonate concentration above the prescribed
bicarbonate concentration of the dialysate. Physicians should
is unclamped.
consider this possibility in prescribing bicarbonate dose. 4. Snap bloodline into blue guides on modules
(do not insert into venous clamp yet).
Prescription of insufficient bicarbonate may contribute to metabolic 5. Snap dialyzer end of bloodline into dialyzer
acidosis; excessive bicarbonate may contribute to metabolic alkalosis.
Both conditions are associated with poor patient outcomes, including holder clip.
increased mortality risk. 6. Aseptically place patient end of venous line into
priming bucket clip.
Dialyzer:
3 1. Place dialyzer into holder, arterial end up. 4
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Prime Extracorporeal Circuit
1. Connect dialyzer end of arterial line to the arterial 9. The blood pump will continue to run until the pre-set
port of the dialyzer. Rotate the dialyzer to the arterial amount of saline has been flushed through the circuit.
end down position. When blood pump stops, clamp the patient end of the
2. Connect the dialyzer end of the venous line to the venous bloodline.
venous port of the dialyzer. 10. Insert the venous line in venous line clamp and optical
3. Hang a saline bag and attach an administration line, if detector and close the optical detector door.
not already attached, to the saline port on the arterial 11. Fill venous drip chamber with level adjust key, clamp
bloodline. Aseptically spike the saline bag. venous monitor line and disconnect from machine so
4. Gravity prime the patient end of the arterial bloodline pressure port is open to atmosphere.
below the saline “T” with saline. When primed, clamp 12. Aseptically connect patient ends of arterial and venous
off the patient end of the arterial bloodline. bloodlines together and open arterial and venous
5. If the heparin pump is to be used: connect heparin bloodline clamps.
syringe, prime heparin line and load heparin syringe 13. Set the blood pump rate to 350-400 ml/min. Press the
into heparin pump. If heparin pump is not used, blood pump Start/Stop key to start the pump and
clamp the heparin line. begin recirculation. If necessary, press RESET to clear
6. Press the Prime key. any alarms.
7. Press the blood pump Start/Stop key. Set blood 14. Ensure that the extracorporeal circuit is free of air bubbles.
speed to 150 ml/min.
8. Fill arterial drip chamber to an acceptable level
using level adjust key. Clamp arterial monitor line
and disconnect from machine so pressure port is
open to atmosphere.
5 6
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Test Recirculation
1. To run the tests, verify: 1. Rotate the dialyzer so the arterial end is up.
• Dialysate lines are on the shunt interlock with the 2. Check the conductivity and pH of the dialysate and test
interlock door closed. for residual disinfectant.
• The machine is alarm-free.
• Arterial and venous pressure monitor lines are WARNING
Always verify the conductivity and approximate pH of the dialysate solution
clamped and disconnected so the pressure ports through independent means (e.g., using a conductivity meter or pH paper
are open to atmosphere. or meter, as applicable) before initiating each dialysis treatment. Verify that
the conductivity is reasonably close to the theoretical value (TCD) and the
• UF and SVS are off. pH is between 6.9 and 7.6. If they are not, do not initiate dialysis.
2. Press the Test & Options screen-key and press
CONFIRM. 3. Attach dialysate connectors to dialyzer (using counter-
3. Select and confirm the Both Tests button to begin current flow, red to red and blue to blue) and close
running the pressure and alarm tests. shunt door.
4. When the message “Test Complete” is displayed in the 4. Connect the arterial and venous pressure monitor lines
Status Box, press RESET to clear message. to their respective pressure ports. Unclamp the lines.
5. When the dialysate compartment is filled, rotate the
dialyzer so the arterial inlet is down.
6. Press RESET to clear all alarms. Set the blood pump
rate to 350-400 ml/min and start the blood pump to
begin recirculating saline through the circuit.
7 8
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Recirculation (continued) Starting Dialysis
7. Test the level detector by pressing on the level adjust 1. Complete patient assessment per unit policy.
down arrow key on the level detector to lower the 2. Wrap blood pressure cuff around the patient’s
fluid level in the venous drip chamber. Verify that the non-access arm.
blood pump stops and the venous clamp closes. Use 3. Verify ultrafiltration is off (UF light on control panel is
the up arrow key to raise the level back to an off) and that the UF Removed button is reset to zero.
acceptable level. 4. Verify the venous line is in the venous clamp and the
8. Check blood tubing to ensure there are no kinks. optical detector. Verify that the optical detector door
9. Replace saline bag with a fresh bag if necessary. is closed.
10. Check for a normal dialysate flow by watching the float WARNING
in the dialysate line. Open the shunt door to verify the Discard the recirculated saline and fill the bloodlines with fresh,
sterile saline.
machine goes into bypass by observing the float in the
dialysate line. Close the shunt door again. 5. Lower the blood pump rate to 150 ml/min and
11. Set treatment parameters as prescribed. press the Start/Stop key to stop blood pump.
6. Connect the patient and initiate treatment per
unit protocol.
7. Press the Start/Stop key to start blood pump
and set QB & QD to prescribed rates.
8. Rotate the dialyzer to arterial end up.
9. Select the Tx Clock button and press CONFIRM
to start the treatment, the Status Box will now
show “Dialysis.”
10. Check that UF/SVS/Heparin are on, if prescribed. If
applicable, a blood pressure measurement is initiated.
9 10
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Completion of Dialysis
1. Press RESET to clear any alarms. 8. Empty the dialyzer:
2. Using navigational arrows, highlight Tx Clock button • Open the shunt interlock door and return the blue
and then CONFIRM. The Status Box will now show dialysate line to the shunt interlock. Place a dialyzer cap
“Dialysis Paused.” on the open dialyzer port.
3. Press the Start/Stop key on the blood pump to stop • Rotate the dialyzer so the red connector is down
the pump. then close the shunt door. The Status Box will
4. Replace saline bag with a fresh bag, if necessary. display “Emptying.”
5. Rinse the blood in the patient end of the arterial • When “Emptying stopped” is displayed, open the shunt
bloodline back to the patient: door, return the red dialysate line to the shunt interlock
• Using a hemostat, clamp the arterial bloodline directly and close the shunt door. Place a dialyzer cap on the
above the saline “T.” open dialyzer port.
• Open the saline line clamps and rinse the blood in 9. Discard the bloodlines, transducer protectors, and dialyzer
the tubing below the saline “T” back to the patient. according to unit policy.
When the blood in the line has been rinsed back to 10. Clean or disinfect the machine exterior according to
the patient, close the saline line clamps. unit policy.
6. Rinse the remaining blood in the bloodline back to 11. If there is another patient:
the patient: Press the New Tx key and then CONFIRM. The
• Clamp the arterial bloodline directly under the treatment parameters will be reset.
saline “T.”
• Remove the clamp on the bloodline above the If there is not another patient:
saline “T” and open the saline line clamps. Return acid and bicarb connectors to their respective ports
• Start the blood pump and set a rate of 150-200 ml/min. securely and proceed with cleaning and disinfecting.
• When the blood has been returned to the patient, turn
the blood pump off and close the saline line clamps.
7. Clamp the arterial and venous bloodlines and the
patient’s arterial and venous access lines and aseptically
disconnect them.
11 12
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Acid Clean & Heat Disinfect Acid Clean & Chemical Rinse (Bleach)
1. To run the cleansing/disinfecting program, verify: 1. To run the cleansing/disinfecting programs, verify:
• Dialysate lines are securely on the shunt. • Dialysate lines are securely on the shunt.
• Acid and bicarb connectors are securely inserted • Acid and bicarb connectors are securely inserted into
into machine ports. machine ports.
2. After the last treatment of the day, highlight the 2. After the last treatment of the day, highlight Acid Clean
Acid Clean button and then press CONFIRM. button and then press CONFIRM.The lines will be rinsed.
The lines will be rinsed. 3. When prompted, connect acid (red) and bicarb (blue)
3. When prompted, connect acid (red) and bicarb (blue) connectors to a jug containing acid cleaner.
connectors to jug containing acid cleaner. 4. Press CONFIRM to start.
4. Press CONFIRM to start the Acid Clean program. 5. When the Acid Clean program is completed, the message
5. When completed, the message “Put Connectors in “Put Connectors in ports” will appear. Put acid and
ports” will appear. Put acid and bicarb connectors bicarb connectors securely into respective machine
securely into respective machine ports and press ports and press CONFIRM to exit.
CONFIRM to exit. 6. Highlight the Chemical/Rinse button on the
6. If the “Auto Heat Disinfect” service mode “Select Program” screen and press CONFIRM.
option is set: The lines will be rinsed.
Leave the machine on the “Select Program” screen. The 7. When prompted, connect the red acid connector to a jug
heat disinfect program will run at the scheduled time. containing chemical disinfectant and press CONFIRM.
8. When completed, the message “Put Connectors in Ports”
If the “Auto Heat Disinfect” service mode will appear. Return red acid connector securely to machine
option is not set: port and machine will initiate a mandatory post-rinse.
Highlight the Heat Disinfect button on the “Select 9. If applicable, the machine will then run an automatic
Program” screen and press CONFIRM to start the DIASAFE® filter test. When the message “Diasafe Test
Heat Disinfect program. The lines will be rinsed with Passed” is displayed, press CONFIRM to exit.
hot water. After the heat disinfect is complete, press 10. Test for residual disinfectant prior to starting treatment
CONFIRM to exit. Press and hold the POWER following a chemical disinfection. When the residual
key to turn off the machine. disinfectant test results are negative, press and hold
13 the POWER key to turn off the machine. 14