Overview
Angel
®
cPRP System Operator’s Manual vii
Before You Get Started
Introduction
The Angel
®
Concentrated Platelet Rich Plasma (cPRP) System (Angel System) is
designed to separate autologous blood or a mixture of blood and bone marrow. The
primary blood components that the Angel System separates and collects are red
blood cells (RBC), platelet poor plasma (PPP) and platelet rich plasma (PRP).
The Angel System utilizes a Variable Volume Separation Chamber that is capable of
processing between 40 mL to 180 mL of anticoagulated whole blood or mixture of
blood and bone marrow in a single cycle. A maximum of 180 mL can be processed in
up to three (3) cycles for each disposable Angel
®
Concentrated Platelet Rich Plasma
(cPRP) System Processing Set (Angel Processing Set or Disposable Set).
This manual is intended for users of the Angel System. The procedures
recommended in this Operator’s Manual have been developed and tested to provide
safe, reliable and efficient operation of the Angel System. It is important that the
operator thoroughly understand the information in this Operator’s Manual before
attempting to use the Angel System.
Indications for Use
The Arthrex Angel System is indicated to be used intraoperatively at the point of
care for the safe and rapid preparation of autologous platelet poor plasma and
platelet concentrate (platelet rich plasma) from a small sample of peripheral blood
or a small sample of a mixture of peripheral blood and bone marrow. The platelet
poor plasma and platelet rich plasma are mixed with autograft and/or allograft
bone prior to application to a bony defect for improving handling characteristics.
Disclaimer: Platelet Rich Plasma prepared from a mixture of whole blood and bone
marrow may contain higher levels of plasma free hemoglobin than Platelet Rich
Plasma prepared from whole blood.
Contraindications for Use
The Angel System may be contraindicated in cases where there are active systemic
infections or systemic heparinization.
Warnings
1. This device is intended to be used by a trained medical professional. A trained
operator should be present at all times to operate and monitor the Angel System
during processing.
2. Biohazard waste, such as needles and contaminated surgical equipment, should
be safely disposed of in accordance with the institutions policy. Disposal of used
equipment and/or used Angel Processing Sets should be performed in
accordance with federal, state, and local regulations. These materials should be
considered biohazardous. Universal precautions for blood-borne pathogens
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