Arthrex

Angel cPRP & Bone Marrow Processing Systems

Angel cPRP System Processing Set Instructions for Use Rev 0 May 2021

Instructions for Use

8 Pages

Angel® Concentrated Platelet-Rich Plasma (cPRP) Processing Set  GB - ENGLISH SET CONTENTS  Instructions for Use DFU-0259-4 Revision 0 05/2021 GB – ENGLISH - INSTRUCTIONS FOR USE  1 Platelet Cuvette / Valve Assembly 2 Rotating Valve 3 Platelet Cuvette 4 Pump Loop Tubing 5 Threaded Luer Caps: quantity, 3 each  6 Whole Blood Compartment 7 RBC Compartment 8 PPP Compartment 9 Three-Compartment Reservoir Bag 10 Syringe Activated PRP Valve Port  11 Variable Volume Separation Chamber 12 20 ml Luer Lock Syringe 13 Male-Female Luer Plugs: quantity, 7 each  Figure 1 - Angel® Concentrated Platelet-Rich Plasma (cPRP) Processing Set Variable Volume Separation Chamber: The Angel Concentrated Platelet-Rich Plasma (cPRP) Processing Set (Angel cPRP Processing Set) utilizes a variable volume separation chamber (Item 11) that can process from 40 ml - 180 ml of anticoagulated autologous whole blood or a mixture of blood and bone marrow in a single cycle... latelet Cuvette/Valve Assembly: The platelet cuvette/valve assembly contains three major components: (1) the platelet cuvette (Item 3), (2) the pump loop tubing (Item 4) and (3) the rotating valve (Item 2)... he top section of the variable volume separation chamber (Item 11) is the separation chamber plate... he separation chamber plate is used to seat the variable volume separation chamber in the centrifuge... he platelet cuvette/valve assembly has been designed so that the operator can easily install the platelet cuvette/valve assembly while insuring that the platelet cuvette is properly seated in the platelet sensor and that the rotating valve aligns with the valve assembly driver... RP Valve Port: The Syringe Activated Valve (Item 10) is included as an accessory and can be manually applied to the PRP Port as illustrated above... t is used to maintain a closed port (if desired) when the PRP syringe is removed...  luer  DFU-0259-4r0_fmt_en-US  Page 1 of 8   lock syringe is attached to the Syringe Activated PRP Valve Port to collect PRP... t the end of a processing cycle, the PRP valve port can also be used to collect PPP by drawing back on the PRP syringe plunger... hree-Compartment Reservoir Bag: The three-compartment reservoir bag is used to collect anticoagulated whole blood, the mixture of blood and bone marrow, and the separated blood components... he whole blood compartment is used as a reservoir for collected anticoagulated whole blood/ bone marrow from a patient... he clinician may use syringes or whole blood bags to collect anticoagulated whole blood or a mixture of blood and bone marrow from a patient... he RBC Compartment is used to collect the concentrated red cells at the end of the processing cycle... he PPP Compartment is used to collect platelet poor plasma; the PPP is the first blood component collected after separation has been completed... yringe activated valves are used to access the PPP and whole blood compartments of the three-compartment reservoir bag... ther items in the Angel cPRP Processing Set include: 20 ml Luer Lock Syringe: The 20 ml luer lock syringe is used for the collection of platelet rich plasma... owever, the syringe activated PRP valve will accommodate most luer fitting syringes... ale/Female Luer Plugs: The male/female luer plugs can be used during and at the end of the procedure to seal open luer lock connections... abels: Appropriate labels supplied with kit, to label collected whole blood and separated components... ESCRIPTION The Angel cPRP Processing Set consists of a pre-connected variable volume separation chamber, a tubing set with a platelet sensor/valve assembly and a three-compartment reservoir bag for the collection of blood products (whole blood, red blood cells and platelet poor plasma respectively)... he Angel cPRP Processing Set also contains a 20ml luer lock syringe for the collection of platelet rich plasma (PRP), male-female luer plugs and labels for collected blood components... ontents of this set have been sterilized by ethylene oxide gas and have non-pyrogenic fluid pathway... NDICATIONS FOR USE The 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... he 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... isclaimer: 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... ONTRAINDICATIONS The Angel cPRP Processing Set may be contraindicated in cases where there is active systemic infection or systemic heparinization... ARNINGS 1... his device is intended to be used by a trained medical professional... nly Angel cPRP Processing Sets are approved for use with the Angel® Concentrated Platelet-Rich Plasma (cPRP) System... o not use the Angel cPRP Processing Set if the sterile packaging barrier has been broken... arefully examine the Angel cPRP Processing Set for damage, prior to use... o not use if the Processing Set is damaged... arefully observe the Angel cPRP Processing Set for leaks during use... eakage may result in loss of sterility of the device and/or loss of blood product... hen collecting and processing autologous blood products or a mixture of blood and bone marrow, it is recommended that the following precautions be followed to insure that the autologous product is not contaminated...  Use sterile technique when setting up the Angel cPRP Processing Set...  Thoroughly clean and disinfect the donation site...  Use sterile technique whenever handling autologous blood products... he whole blood or the mixture of blood and bone marrow must be anticoagulated before it can be processed for separation... nadequate anticoagulation may result in clotting, interfering with the processing of the blood products... lood/ bone marrow containing clots will not pass through the syringe-activated valve located on the Whole Blood compartment of the three-compartment reservoir bag... DFU-0259-4r0_fmt_en-US  Page 2 of 8
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