5. TERMINATION OF TREATMENT
5.1 When the treatment is completed, stop the blood pump, disconnect the "arterial" line from the vascular access of the patient and connect it to a bag of
saline. Turn on the blood pump on to low flow rates (usually 50 mL/min). Ensure that there is enough 0.9% sterile saline solution in the bag (usually
250 mL) for rinsing the blood in the extracorporeal circuit back to the patient.
Note: Terminate the treatment as directed by the manufacturer's instructions for use included with the bloodlines and blood pump.
5.2 Discard the bloodlines and Seraph 100 in an appropriate biohazard waste receptacle.
6. PERFORMANCE CHARACTERISTICS
Blood Priming Volume: 160 mL
Blood Flow Rate (min, max): 100, 350 mL/min
Priming Fluid: Physiologic Saline
Sterilization: Ethylene Oxide (ETO)
Treatment duration (per Seraph 100): 4 ± 1 hours
7. BLOOD CONTACTING MATERIAL
The patient body tissue (blood) contacting materials of Seraph 100 are listed in the following table. The duration of the contact with blood is limited and less
than 24 hours in all cases.
Device Component
Column Body and End Caps
End Plate
Adsorption media, beads
End Point Attached Heparin
8. ACCESSORIES
Seraph 100 is compatible with standard hemodialysis circuits and connectors. Seraph 100 is compatible with the standard large-bore female threaded dialyzer
connectors. When treating with Seraph 100 and a dialyzer/hemofilter simultaneously, a Female-Female Luer Lock Connector is required to connect Seraph 100
to the dialyzer/hemofilter.
9. WASTE MANAGEMENT
Make sure that all local requirements and the health center's policy on precautions and prevention of infections and environmental contamination are met when
the Seraph 100 components and other residues (tubes) are discarded.
10.
ExThera Medical Corporation
757 Arnold Drive, Suite B
Martinez, CA 94553 US
Seraph
+1 925-839-2060
Seraph
+1 925-839-2075
Stand-Alone Configuration
Stand-Alone Configuration
Seraph 100 in Stand-Alone Configuration
Venous
pressure
sensor
Pressure
Blood
sensor
Blood
pump
pump
Arterial
Arterial
pressure
pressure
sensor
sensor
Arterial
Venous
Arterial
Venous
Patient
Materials
Copolyester, DuraStar™ Polymer
Hydrophilic porous polyethylene
Ultra-high molecular weight polyethylene
Heparin Sodium, USP
11.
ExThera Medical Europe B.V.
Selzerbeeklaan 3B
6291 HV Vaals NL
100 in
®
+31 43 8200 399
100 in
®
+31 43 8200 372
Venous
pressure
sensor
Pressure
sensor
Venous drip
Venous drip
chamber
chamber
Air trap and
Air trap and
air detector
air detector
Patient
Seraph® 100 and Dialyser
Seraph® 100 and Dialyser
in Combination Configuration
in Combination Configuration
Seraph 100 and Dialyser in Combination Configuration
Blood
pump
pump
Arterial drip
chamber
Arterial
pressure
sensor
Arterial
Arterial
Venous
3
Venous
Venous
pressure
pressure
sensor
sensor
Blood
Arterial drip
chamber
Venous drip
Venous drip
chamber
chamber
Arterial
pressure
sensor
Air trap and
Air trap and
air detector
air detector
Venous
Patient
Patient
©12 2019 CP009 Rev D