Clotalyst® - Biomet

Clotalyst ®Autologous Serum Collection System

Clotalyst ®Autologous SerumPlatelet gel derived from the GPS ® III System in combination with Clotalyst ® Autologous SerumThe Clotalyst ® Autologous Serum Collection System produces approximately 6 ml ofautologous serum from only 12 ml of patients’ own citrated blood. The serum output canbe mixed with platelet rich plasma (PRP) produced by the GPS ® III system.The Clotalyst ® Autologous Serum Collection System provides the surgeon an uniqueproduct for bone graft handling prior to application to the orthopedic surgical site.

Preparation of the Clotalyst ®Autologous SerumStep 1: DrawDraw 12 ml of citrated blood in a 12 ml syringe(1ml of anticoagulant and 11 ml of blood).Gently mix the whole blood and anticoagulantupon collection to prevent coagulation.Step 2: LoadRemove Clotalyst ® reagent syringe from sterile pouchand attach plunger.Note: Leave grey stopper on opposite end ofreagent syringe when attaching plunger.Remove grey stopper on reagent syringe. Unscrewblue cap on port No. 2 of disposable and attach reagentsyringe. While holding the Clotalyst ® disposablevertically, completely inject 4 ml of reagent. Removethe reagent syringe from the disposable. Removeprotective cover on white cap and discard. Screw thewhite cap onto port No. 2.

Technique (continued)Step 2: Load (continued)Unscrew red cap on port No. 3 and attach syringe thatcontains 12 ml of citrated blood.While holding disposable vertically, inject blood untilsyringe is empty.Remove the empty syringe. Remove protective coveron the white cap and discard. Screw white cap ontoport No. 3.

Technique (continued)Step 3: IncubateMix by inverting disposable at least 12 times(gently without producing foam).Place disposable into Clotalyst ® Heater. The glassbeads inside the disposable should be distributedevenly when it is placed into the heater. Press theincubation button to start cycle. When the incubationcycle is complete (25 minutes), the heater will beepfour times.Step 4: BalanceAt the end of the 25-minute incubation period, shakethe Clotalyst ® disposable enough to dislodge andbreak up any gel that may be present.

Technique (continued)Step 4: Balance (continued)Place Clotalyst ® disposable in the centrifuge with theempty Clotalyst ® orange counterbalance (800-0760)in the opposite side of the centrifuge.Step 5: SpinClose centrifuge lid and set speed to 3200 RPMs andtime to 5 minutes. Press green button to start centrifugecycle. Once cycle is complete, press red buttonto open lid.Step 6: Autologous Serum ExtractionGently remove the disposable from the centrifuge withoutdisturbing the stratified layers. Unscrew the yellowcap from the center port while holding the disposablevertically. Connect sterile 12 ml syringe to the centerport and extract 5 to 6 ml of autologous serum.

Technique (continued)Step 6: Autologous Serum Extraction (continued)To maximize harvest volume, the disposable maybe tilted towards port No. 3 as autologous serum isextracted.Step 7: StoragePlace cap supplied onto syringe and store between2–6°C if autologous serum is not used within 1 hour.Storage RequirementsAnticoagulantStorage RequirementsWhole Blood8–12% ACD-AWhen used immediately or within one hour:Store between 18–26ºCWhen used after one hour: Store between 18–26ºC (up to 4 hours)

Clotalyst ® System Ordering InformationAccessories ContinuedDescriptionCatalog NumberAerosol Spray Kit with Two Sets of Syringes and Two Tips 800-0260Graft Preparation System 800-0300ATM100 Autologous Mixer TipATM100ST-3 Tip (Ten Pack) to be used with 800-0204ST-3 TIP

All trademarks herein are the property of Biomet, Inc. or its subsidiaries unlessotherwise indicated.This material is intended for the sole use and benefit of the Biomet Biologics salesforce and physicians. It is not to be redistributed, duplicated or disclosed without theexpress written consent of Biomet.For product information, including surgical techniques, indications, contraindications,warnings, precautions and potential adverse effects, see the Biomet Biologicswebsite at www.biometbiologics.comP.O. Box 587, Warsaw, IN 46581-0587 • 800.348.9500 x 1501©2009 Biomet Orthopedics • www.biomet.comForm No. BIV0029.0 • REV063009