ExThera Medical Seraph 100 Microbind Instrucciones De Uso

1. INTRODUCTION
1.1 INTENDED USE
Seraph® 100 Microbind® Affinity Blood Filter (Seraph 100) is a single use extracorporeal broad-spectrum sorbent hemoperfusion device for reduction of
pathogens from the bloodstream.
1.2 INDICATIONS FOR USE
Seraph 100 is indicated for the reduction of pathogens from the bloodstream in adjunction to antibiotic treatment during BSI (blood-stream infections).
1.3 CONTRAINDICATIONS
The treatment with Seraph 100 is contraindicated in the following cases:
Patients with proven heparin-induced thrombocytopenia (HIT), or patients with hypersensitivity to heparin
Patients with very low platelet counts
Patients with active and uncontrolled bleeding and hemorrhagic shock
Patients for whom extracorporeal circulation therapy is contraindicated, such as those with severe cardiac insufficiency, acute myocardial infarction, severe
cardiac arrhythmia, acute seizure disorder, or severe uncontrolled hypertension or hypotension
Anticoagulation treatment is associated with a higher risk of hemorrhage, mostly after a surgical intervention. The decision to use Seraph 100 for a
patient on anticoagulation therapy must be made by a physician.
1.4 WARNING AND PRECAUTIONS
Warnings
1.4.1 Seraph 100 is a disposable medical device valid for single use only. Do not reuse!
1.4.2 Clamp Seraph in a vertical orientation during use with the arrow on the device pointing up. Check the direction of the blood flow through the Seraph to
assure that it is in the direction of the arrow: from bottom to top.
1.4.3 Seraph 100 should not be used if dropped.
1.4.4 Seraph 100 should not be used beyond use by date.
1.4.5 Seraph 100 should not be used if the sterilization barrier is compromised. Do not resterilize the Seraph 100.
Precautions
1.4.6 Seraph 100 should only be administered by personnel that has been properly trained in administration of extracorporeal therapies.
1.4.7 As in all extracorporeal treatments, the trained personnel must monitor the patient at all times during the treatment.
1.4.8 The safety of the treatment in pregnant women and patients under 18 years of age has not been determined.
1.4.9 Carefully check all extracorporeal circuit connections before and during the procedure.
1.4.10 Since the device is sterilized with ethylene oxide (ETO), allergic reactions are possible.
1.5 POTENTIAL ADVERSE EVENTS/SIDE EFFECTS
The following side effects or adverse reactions could theoretically occur while using Seraph 100:
In rare cases, hypersensitivity reactions may occur during extracorporeal treatment. A history of allergies (heparin, polyethylene, copolyester, ETO) is an
indication requiring careful monitoring for hypersensitivity reactions.
Note: In the event of a hypersensitivity reaction, treatment must be discontinued and aggressive, first line therapy for anaphylactoid reaction must be initiated.
The decision to return the blood to the patient encountering a hypersensitivity reaction must be made by a physician.
The patient should also be monitored for other clinical events associated with extracorporeal treatment, including but not limited to hypotension, anemia/
decreased hematocrit, hypovolemia, thrombocytopenia, cardiac dysrhythmia, hemolysis and hematoma formation at the venipuncture site.
Other less frequently observed events than can be observed are chest pain, dyspnea, and hypertension after treatment.
1.6 LIMITATIONS
The safety of the treatment using Seraph 100 device in pregnant women and patients under 18 years of age has not been determined.
Seraph 100 is a single-use device.
1.7 STORAGE AND HANDLING CONDITIONS
Avoid any impact during transport and handling, as the casing or other components may be damaged. Do not hit the device.
Storage conditions: temperature range of 15-30 degrees Celsius.
Use the device before the use by date indicated on the product label.
2. BEFORE STARTING THE TREATMENT
Aseptic procedures should be used for all steps below.
2.1 Seraph 100 is intended for use with standard, commercially available bloodlines compatible with the pump system used. Female Luer connectors are
required to connect with Seraph 100 blood ports. The blood pump should be capable of delivering up to 400 mL/min blood flow rate.
Seraph® 100 Microbind® Affinity Blood Filter
Sorbent Hemoperfusion Filter
STERILE / SINGLE USE / NOT REUSABLE
DO NOT USE IF THE PACKAGING IS OPEN OR DAMAGED
READ CAREFULLY THIS INSTRUCTIONS FOR USE
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Instructions for Use
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©12 2019 CP009 Rev D