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Pressure monitoring of the bloodline between the blood pump and the Seraph 100 device is recommended.
2.2 Inspect the protective pouch for any sign of damage to the Seraph 100 device. Carefully remove Seraph 100 from the pouch and examine for defects.
Note: The fluid pathway in an intact device inside the protective pouch is sterile.
DO NOT USE Seraph 100 if it appears to be damaged.
2.3 Locate the inlet (arterial) end of the device. With the inlet end of the device facing downward, firmly secure Seraph 100 in a vertical position to the pump
system's device holding pole (or alternate device holding system) using a standard dialyzer clamp.
Note: When the Seraph 100 is placed in a vertical position with the inlet end of the device facing downward, the flow arrow on the label is pointing
upward.
2.4 Install the arterial and venous bloodlines on the blood pump.
Note: Refer to the manufacturer's instructions for the blood tubing set and blood pump.
2.5 Aseptically spike 0.9% sterile normal saline with a clamped Intravenous (IV) administration set. Attach the IV administration set to the patient end of the
arterial bloodlines. Ensure all connections are secure in every step. Alternatively, online produced filtration fluid of a regular hemodialysis machine can be
used.
2.6 Open the clamp on the IV set. Prime the arterial bloodline with saline solution using a blood pump speed of approximately 150 mL/min.
Note: Refer to the manufacturer's instructions for the blood pump.
2.7 Stop the blood pump and clamp the line. Ensure that Seraph 100 is placed in a vertical position with the inlet end of the device facing downward and the
flow arrow on the label is pointing upward. Remove the inlet port plug of Seraph 100 and connect the primed arterial bloodline to the inlet port. Remove
the tubing clamp.
Avoid the entry of air into Seraph 100 during the priming procedure.
2.8 Turn on the blood pump and prime the Seraph 100 with 1 L of saline solution using a blood pump speed of approximately 150 mL/min.
2.9 Examine if air bubbles are observed within the inlet of the device. If air bubbles are detected, gently thump the outlet side of the device with the palm of
your hand during the priming to remove them.
Note: If stubborn bubbles are present, turn of the pump and aseptically connect a 40 – 60 mL syringe filled with saline to outlet tubing of the device
(venous bloodline). Rotate the Seraph 100/clamp 180° so the flow arrow on the label is pointing downward and the bubble on the inlet side is visible.
Using the syringe to push saline into the device until the air bubble is pushed into the saline bag and there are no visible air bubbles in the Seraph 100 or
tubing. Aseptically connect the Seraph 100 inlet to the dialysis circuit. Rotate the Seraph 100/clamp 180° into a vertical position with the arrow on the
label is pointing upward. Remove the syringe.
2.10 Attach the venous line to connect the Seraph 100 outlet to the dialysis circuit.
2.11 Turn on the blood pump and prime the venous line at approximately 150 mL/min.
2.12 Turn the blood pump off.
Verify that the circuit connections to Seraph 100 are as shown in the illustration (on reverse page). DO NOT kink any of the blood lines.
2.13 The priming of the extracorporeal circuit should be completed with blood pump speed of approximately 150 mL/min and with a minimum of 1 L of
normal saline / online produced filtration fluid.
Note: Use the Seraph 100 immediately after rinsing and priming.
2.14 In case concomitant renal replacement therapy (dialysis, hemofiltration, CRRT) is required, Seraph 100 shall be placed prior (proximal or upstream) to the
dialyzer or hemofilter. An accessory bloodline between Seraph 100 and the dialysis device is required. Priming will require a minimum of 1L of normal
saline, and anticoagulation should be tailored to the treatment.
3. INITIATION OF TREATMENT
3.1 Anticoagulation
Heparin: Patient shall be anticoagulated with a bolus of heparin to an ACT of 160 – 210 seconds or an aPTT of 60 – 80 seconds prior to the start of treatment.
Systemic heparinization during hemodialysis is recommended with a 3 to 5-minute waiting period after the initial heparin bolus.
Anticoagulation with an excess of heparin is associated with a higher risk of hemorrhage, mostly after a surgical intervention. Physician shall
monitor and pay attention to the recommended doses throughout the treatment. The use of citrate as anticoagulation for patients undergoing
Seraph 100 therapy is not known. The decision to use citrate must be made by a physician.
3.2 Increase the blood pump speed slowly to a blood flow rate of 100-350 mL/min.
Be sure to monitor the arterial and venous blood pressure carefully during this process to note any possible flow restrictions or inappropriate
pressure readings.
3.3 Treatment should be continued for 4 ± 1 hour.
Note: If being used with a dialysis device, initiate treatment as directed by the manufacturer's instructions for use included with the hemodialyzer. Once
the prescribed blood flow rate has been achieved, set the prescribed ultrafiltration rate and rotate the dialyzer to the arterial end up position.
4. DURING TREATMENT
4.1 Monitor the pressure in the extracorporeal circuit, including the line between the blood pump and Seraph 100, if available. Investigate any indication of
abnormal pressure.
4.2 Visually inspect the Seraph 100 for any signs of clotting or blood leaks from the circuit or within the dialyzer. Report all clotting or blood leaks to the
responsible medical professional.
4.3 Periodically monitor the extracorporeal circuit for evidence of obstruction, security of fittings, and air within the circuit.
Air entering the extracorporeal circuit during dialysis can result in serious injury or death. Should air get into the venous line during the treatment,
the dialysis treatment must be discontinued without returning any of the blood mixed with air to the patient.
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©12 2019 CP009 Rev D
