Setup and Prime of COBE Centrysystem 3 / Centrysystem 3®® TM

Plug in power cord, place drain line into drain, turn water on, then turn machine on. Connect concentrates. Place the BiCart in BiCart holder and press BiCart PRIME button (if applicable). Perform the WHO Function Verification prior to every treatment.Autotest can be run before or after connecting concentrates. Do not connect concentrates during AUTOTEST. Do not remove dialysate lines from the machine during AUTOTEST. Do not draw a conductivity test during AUTOTEST.

1. Press AUTOTEST if AUTOTEST is to be performed, or press OVERRIDE if AUTOTEST is not required. AUTOTEST is required every 24 hours or if the machine had been turned off for >30 minutes.2. Press LOAD/UNLOAD to open the blood pump door, put the blood pump segment and Cartridge in place.3. Place the venous bloodline behind the air bubble detector. Press LOAD/UNLOAD to close the blood pump door.4. Press the PRIME button, note the three dashes (---) in the blood pump display.5. INSERT THE REMAINING LINES IN THIS ORDER: 1) place the heparin line, arterial access line, Cartridge saline line, and venous access lines into their appropriate clamps and close the clamps, 2) connect the arterial pumping chamber line to the dialyzer, 3) place a plastic hemostat on the venous dialyzer line (this will be gravity primed before connecting it to the dialyzer), 4) insert the venous bloodline into the venous line clamp, 5) insert the arterial bloodline into the arterial line holder.6. Close the clamp on the saline administration line that is attached to the venous bloodline, and spike the saline bag.7. Open the clamp on the saline administration line.8. Unclamp the hemostat on the venous dialyzer line to gravtiy prime it, then connect it to the venous end of the dialyzer. 9. Close the clamp on the arterial bloodline and place it into the WHO utilizing the priming connector, or into a prime collection container. Initiate priming of the bloodlines within 30 seconds of connecting the arterial bloodline to the WHO.10. Press the blood pump ON/OFF softkey to start the pump, then unclamp the arterial bloodline. (Failure to open the clamp on the arterial bloodline during prime can result in the Cartridge breaking.)11. Adjust the arterial and venous Cartridge drip chamber levels.12. Attach a heparin syringe with the correct dose of heparin to the heparin line and place in heparin pump. Select the HEPARIN SCREEN, unclamp the heparin line, and press START PRIME to prime the heparin administration line.13. Run _______ cc's of saline through the system, the pump will stop automatically with PRIME STOP option.14. Press BYPASS, and connect the dialysate lines to the dialyzer, than press BYPASS again to start the flow of dialysate through the dialyzer. (DO NOT CONNECT DIALYSATE LINES DURING AUTOTEST.)15. After the pump has stopped, clamp the arterial, venous, and saline lines. Press the PRIME button to come out of PRIME.16. Connect the saline administration line to the Cartridge saline line.17. Connect the arterial and venous bloodlines together using the priming connector on the venous line. Retain the priming connector that has been in contact with the WHO for the WHO Function Verification. Reposition the WHO rinse arm in the drain port. NOTE: DO NOT USE this priming connector for patient use.18. Unclamp the arterial line, venous line, saline administration line, and Cartridge saline line clamps (4 LINES TO UNCLAMP).19. Press the blood pump ON/OFF softkey to start the pump. Increase the bloodflow to ______ cc's/min.20. Select DIALYSATE SCREEN, select TMP Limits and Dialysate Flow, set Dialysate Flow Rate by pressing the softkey, then use the up and down arrows to adjust the flow rate. The Dialysate Flow Rate must be set in the SETUP MODE.21. Select the MODE SCREEN and select RECIRCULATE MODE (if applicable). The system will then recirculate for ____ minutes with a UFR of _____ . Increase the blood pump rate to _____ cc's/min during recirculation.22. Perform the WHO Function Verification using the priming connector removed from the arterial bloodline after priming. (Refer to C3/C3 Helpful Hints for directions.)23. After the recirculation period has finished, select the MODE SCREEN and select READY MODE. Select ALARM TEST. Select A to run all tests. All alarm conditions must be cleared before beginning the ALARM TEST. After the alarm test is complete, verify that all alarm tests have passed, and press PASS, then press CANCEL. Override ALARM TEST is an option if the ALARM TEST is not required. ALARM TEST is required if it has not been performed in the past 24 hours, or if the machine has been turned off >30 minutes. It is recommended to perform the ALARM TEST (A for All Tests) prior to every treatment.24. Program Target Loss and Treatment Time. Program Heparin Bolus and Heparin Infusion if applicable.25. If PROGRAMMABLE SODIUM is ordered, select the OPTIONS SCREEN, press PROGRAMMABLE SODIUM, press the ON/OFF softkey to turn it on. Press PARAMETERS and program the desired sodium and time for each level. Program the desired time for each level.26. Flush the extracorporeal circuit with fresh saline. Refer to operator's manual for specific procedure.27. Always verify the pH and Conductivity before initiating dialysis.

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10810 West Collins AvenueLakewood, CO 80215-4439800-525-2623 or 303-232-6800visit us at www.usa-gambro.com

Caution: Federal Law (USA) restricts this device to sale, by or on the order of a physician.Read Instruction for Use prior to patient application.Trademarks used herein are owned by or licensed to Gambro, Inc.©January 2002 Gambro Renal Products, Inc. Printed in the USA 306175-028 Rev. B

Initiation of Dialysis

Discontinuing Dialysis

1. Perform the VENOUS PRESSURE HIGH TEST. Access the PRESSURE UFC SCREEN. With pressure alarm limits open (spread the limits by increasing or decreasing the blood pump rate), clamp the venous bloodline below the Cartridge, observe the venous pressure increase until the Venous Pressure High alarm occurs and the pump stops. Press RESET, then press RESUME to continue.

2. Press the blood pump ON/OFF softkey to start the pump.

3. Clamp the arterial bloodline, venous bloodline, saline administration line and Cartridge saline line.

4. Connect the arterial bloodline to the patient's arterial access line, and place the venous bloodline into the WHO using the priming connector as an adapter.

5. Select the PRESSURE/UFC SCREEN. Unclamp the arterial bloodline and the patient's arterial access line, press the blood pump ON/ OFF softkey to start the pump. When the venous pressure reaches 100 mmHg, unclamp the venous bloodline.

6. Select the HEPARIN SCREEN and press START BOLUS (if applicable).

7. When the first red blood cells reach the venous chamber, clamp the venous bloodline and stop the pump. *

8. Connect the venous bloodline to the patient's venous access line and unclamp the venous bloodline and the patient's venous access line.

9. Select PRESSURE/UFC SCREEN to observe the arterial and venous pressures. Press the blood pump ON/OFF softkey to start the pump. Increase the blood pump speed until the prescribed blood flow rate is achieved taking into account pre-pump arterial and post- pump venous pressure.

10. Select the MODE SCREEN, press DIALYZE to start the treatment.

*Should blood go down the WHO drain port, perform the following procedure: 1) Using a syringe with a priming connector as anadapter, inject 15 cc's of undiluted bleach (5.25 - 6% sodium hypochlorite) into the WHO. WARNING: DO NOT USE this priming connectorfor patient related uses or any sterile connections. 2) Remove the syringe and priming connector and reposition the WHO rinse arm in thedrain port. Failure to reposition the rinse arm in the drain port may result in incomplete rinseout of the bleach. 3) Allow the machine to rinsefor 5 minutes prior to setting up for the next patient.

SET THE TMP ALARM LIMITS AT LEAST FIVE (5) MINUTES AFTER THE PRESCRIBED BLOOD FLOW RATE IS ACHIEVED INDIALYZE MODE.

CENTRYSYSTEM 3: Read the TMP on the STATUS SCREEN, then set the Maximum TMP on the DIALYSATE SCREEN. Recommendedsetting is approximately 30 mmHg above the displayed TMP.

CENTRYSYSTEM 3 : Select DIALYSATE SCREEN, then the TMP LIMITS and DIALYSATE FLOW SCREEN, set theMaximum and Minimum TMP. Recommended setting for the Maximum TMP is approximately 30 mmHg above and Minimum TMPis approximately 30 mmHg below the displayed TMP.

1. Select the MODE SCREEN and select RINSEBACK.

2. Press the blood pump ON/OFF softkey to stop the pump.

3. Clamp the arterial bloodline and the patient's arterial access line. Disconnect the arterial bloodline from the patient's arterial access line and connect it to the saline administration line using the white adapter piece on the Cartridge saline line. Attach a sterile syringe filled with saline to the patient's arterial access line and flush the line to return the patient's blood.

4. Open the clamps on the arterial bloodline and the saline administration line.

5. Press the blood pump ON/OFF softkey to start the pump. Rinse the extracorporeal circuit with _____ cc's of saline.

6. When the system is clear, press the ON/OFF softkey to stop the pump. Clamp the venous bloodline and the patient's venous access line.

7. Disconnect the venous bloodline from the patient's venous access line.

8. Return dialysate lines to machine. Then select SETUP MODE to clear previous patient's data and recalibrate the blood leak detector.

9. The dialysate flow rate returns to the default flow rate of _____ ml/minute when returned to the SETUP MODE.

Note: The disconnect RINSEBACK Procedure is recommended by GAMBRO. This allows saline to flush blood back to the patient with all fluid going past the air bubble detector.

NOTE: The order in which certain steps are completed may vary to accommodate facility procedures.

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P/N 306175-028 Rev. B

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