Calcibon ® Granules
Contents
1. Y o Gravitational Platelet y separation System i Accelerating sd USER MANUAL ih FACTOR TECHNOLOGIES INC ELLE Europe Description The GPS II System separates the blood components present in blood on the basis of density through application of the GPS Thermo International Equipment Company IEC Centrifuge The GPS II System offers the possibility to produce in a short time a platelet concentrate from a small amount of blood taken from the patient just prior to surgery Used materials All materials used in syringes tubes connectors and devices for the separation of platelets supplied with the GPS II System like polymers elastomers and stainless steel are for medical applications The GPS II System contains no Latex Warnings and precautions 1 Aspiration of blood should take place lege artis under sterile conditions 2 Guidelines for the use of the centrifuge should be followed Use only the GPS IEC Centrifuge The results when using other centrifuges are not known 3 Don t use the sterile components of this set when the package is opened or damaged 4 For single use only Do not reuse 5 Prior to using the GPS II System the surgeon should familiarize him herself with the system 6 The patient should be informed about the general risks of the treatment and possible adverse events 7 Use the platelet concentrate within 6 hours after the blood is taken from2. and needles to the nurse in the sterile field 2 Inject the platelet rich plasma PRP into one of the cups CRYO FIBRINOGEN in the tray of the GPS Spray Applicator Kit 3 Inject the thrombin into the second cup THROMBIN in the tray of the GPS Spray Applicator Kit TITT Europe 4 Fill the 12 ml syringe of the sterile GPS Spray Applicator Kit with the PRP The ratio of mixing PRP and thrombin is 10 1 A ee ey ee a ae ruir A e Fibrinogen micr medics inc E 1 5 Fill the 1 ml syringe of the sterile GPS Spray Applicator Kit with the thrombin a AA ELLET Europe 6 Prepare the two component system for the syringes Apply the correct applicator and spray for example the PRP on a wound ST 3 TIP in combination with blending connector tip or inject it into a joint malleable dual cannula tip or mix it with autologous bone or Calcibon granules blending connector tip Cry FACTOR JONEL A TECHNOLOGIES INC sessss Europe Preparation of Platelet Poor Plasma PPP fibrin glue This procedure is carried out in the sterile field 1 Inject the platelet poor plasma PPP into the cup in the tray of the GPS Spray Applicator Kit in which the PRP was injected before CRYO FIBRINOGEN 2 Fill the 12 ml syringe from the sterile GPS Spray Applicator Kit with the PPP The ratio for mixing PPP and thrombin is 10 1 3 Fi
3. cap to plasma port 22 Gently invert TPD at least 7 times 23 Place TPD horizontally on a flat surface with beads distributed evenly 24 Allow TPD to rest at 18 C and 26 C for 20 minutes AND DO NOT DISTURB TFCELL FACTOR ASUME LU TECHNOLOGIES INC seee ee Europe 25 Dissolving the Buffy Coat shake the GPS II container for a minimum of 30 seconds vigorously Important Keep the GPS Il container upright 26 Unscrew the red Luer Lock cap from the side port of the GPS II container and connect a 10 ml syringe Aspirate the PRP and keep the GPS II container upright 27 Close the 10 ml syringe with the PRP with a sterile injection needle YSU sesos Europe 28 Shake TPD vigorously to dislodge and break up any gel that may be present and evenly redistribute beads 29 Place horizontally on a flat surface for an additional 5 minutes AND DO NOT DISTURB 30 After time has elapsed shake TPD vigorously to dislodge gel Thrombin is ready to harvest 31 Remove white luer cap 32 Attach 20 ml syringe to thrombin collection port 33 Turn stopcock A 90 clockwise so the OFF knob points to the left 7 gt BEA 34 Hold TPD upright Draw thrombin into collection syringe WSU ses Europe Preparation of Platelet Rich Plasma PRP gel The procedure is continued in the sterile field 1 Open the GPS Spray Applicator Kit 800 0600 and hand it together with the needed sterile applicators syringes
4. ll the 1 ml syringe of the sterile GPS Spray Applicator Kit with the thrombin 4 Prepare the two component system for the syringes Connect the ST 3 TIP and the blending connector tip Spray the PPP on the different woundlayers during wound closure GH
5. p ST 3 TIP used in combination with the blending connector tip e GPS Blending Connector Tip Single Cannula 800 0204 e GPS Malleable Dual Cannula Tip 20 Gauge x 4 inch 800 0202 e GPS Malleable Dual Cannula Tip 20 Gauge x 7 inch 800 0203 e GPS Malleable Dual Cannula Tip 20 Gauge x 10 inch 800 0206 e GPS Malleable Dual Lumen Endoscopic Tip 5mm x 12 inch 800 0207 SUM sesos Europe Procedure 1 Take the sterile pack with the GPS II container from the GPS II Disposable Kit 2 Aspirate in a 60 ml syringe 6 ml citrate from the citrate bottle Aspirate with this syringe 54 ml blood from the patient The total volume is now 60 ml Mix the citrate and the blood by shaking the syringe a couple of times CELL FACTOR SANSU TECHNOLOGIES INC ses Europe 3 Unscrew the Luer Lock cap with the green transport stick attached to it from the blood port on the top of the GPS II container 4 Screw the syringe with the blood and the citrate on the blood port of the GPS II container 5 Inject the blood slowly into the GPS II container 6 Screw the white Luer Lock on the blood port of the GPS II container 7 Fill the non sterile counterbalance with a sterile sodium chloride solution or sterile water 8 Put the GPS II container in the centrifuge with the red or yellow cap directed towards the center and place the non sterile counterbalance opposite 9 Close the lid of the centrifuge and set the
6. the patient sesos Europe User Manual using GPS II Single Kit For the aspiration of blood the following is needed Disinfectant Tourniquet 1 Butterfly needle or 1 vein puncture needle minimum 16 gauge ACD A citrate solution as anti coagulant for the aspiration of blood included in GPS II disposable kit A sterile 60 ml syringe from the GPS II Disposable Kit to aspirate blood sterile injection needle for the 60 ml syringe to aspirate ACD A citrate solution included in GPS II disposable kit Gloves Sterile gauzes to cover the vein puncture site Plaster To separate the platelets the following is needed Description Article number e GPS Centrifuge including buckets 7427 and one of the GPS II Disposable Kits e GPS Il Disposable Double Kit 800 0621A Or e GPS II Disposable Single Kit 800 0721A and e GPS Non Sterile Counterbalance 800 0508 Or e Mini GPS II Disposable Kit 800 0503A and e GPS Mini Non Sterile Counterbalance 800 0505 along with sterile injection needles 18 gauge sesos Europe To produce autologous thrombin the following is needed Description Article number e Thrombin Processing Device TPD TPD100T 10 pk e Thrombin Reagent TPDRS100T 10 pk To prepare and apply the platelet gel fibrin glue the following is needed Description Article number e GPS Spray Applicator Kit 800 0600 And one or more of the following applicator tips e Spray Ti
7. time at 15 minutes and the speed at 3200 rpm Press the green button to start the centrifugation process Open the centrifuge with the red button once the centrifugation has finished speed 0 10 Take the GPS II container out of the centrifuge NSU seee8ee Europe 11 Aspiration of the platelet poor plasma PPP Unscrew the yellow Luer Lock cap from the side port of the GPS II container and connect a 30 ml syringe 12 Turn the GPS II container upside down and aspirate the PPP Beware that during aspiration of the plasma the blue air valve is not blocked 13 Close the 30 ml syringe with the PPP with a sterile injection needle CELL FACTOR TECHNOLOGIES INC NAT Europe 14 Take the Thrombin Processing Device TPD and the Thrombin Reagent Open the blue Luer Lock cap on the TPD and attach the syringe with the reagent 15 While holding the TPD at an angle of 45 completely inject reagent 16 Remove reagent syringe and replace blue cap 17 Remove yellow Luer Lock cap and attach plasma syringe 18 While holding the TPD upright at eye level slowly inject approximately 11 ml plasma into TPD Stop injecting plasma when the fluid level is between the MIN and MAX lines 19 Turn stopcock A 90 counter clockwise so the OFF knob points down 20 Turn stopcock B 180 counter clockwise so the OFF knob points to the left 2 G 21 Detach plasma syringe and reattach yellow Luer Lock
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