Plasmax® Plasma Concentration System for Laparoscopic ... - Biomet

Plasmax ®PlasmaConcentration Systemfor Laparoscopic Roux-en-YGastric BypassBIOLOGICSThis brochure is for International use only. It is not for distribution in the United States.

The Digestive SystemThis brochure is for International use only. It is not for distribution in the United States.DuodenumStomachLargeIntestine(colon)SmallIntestineIleumJejunumGastric Bypass ProcedureGastric Bypass is one of the fastest growing surgicalprocedures in the world. Although several techniques areused, the most common procedure is a LaparoscopicRoux-en-Y Gastric Bypass (LRYGB) (Figures 1 and 2).Figure 1: Before LRYGBPostoperative Complicationsfollowing a Gastric BypassPostoperative complications following a LRYGB posea significant challenge to the surgeon. In particular,leaks at the anastomoses sites and infection of thewound portals are postoperative disurbances that areassociated with LRYGB. 1,2Figure 2: After LRYGB

The Plasmax ® Plasma Concentration Systemin a Laparoscopic Roux-en-Y Gastric BypassThis brochure is for International use only. It is not for distribution in the United States.1. After the jejunem is divided into two limbs, plasma concentrate can beused for topical hemostasis as necessary.2. An enterenterostomy is made to allow gastric flow from the stomachto the intestinal track. Plasma concentrate can be applied along thestaple line.3. The stomach is sized to a small pouch. Plasma concentrate can beapplied to the staple line.4. An anastomosis, the gastrojejunostomy, is made between the rouxlimb and the new stomach pouch.5. Plasma concentrate is applied to the gastrojejunostomy site.6. PRP is applied to the portal sites during closure.

Ordering InformationThis brochure is for International use only. It is not for distribution in the United States.PART #DESCRIPTION800-0560A Plasmax ® Plus Disposable Kit755VES-230VCentrifuge 230 volt 50-60 Hz (Table Top)800-0512 Plasmax ® Plus Counterbalance800-0250 Manual Spray Kit800-0260 Aerosol Spray Kit with Tip800-0211 Aerosol Regulator w/o vent (non-sterile)800-0215 Endoscopic Aerosol Venting Regulator800-0201 Dual Spray Tip800-0207 12 inch manual endoscopic applicator800-0208 16 inch manual endoscopic applicator800-0216 12 inch aerosol endoscopic rigid tip800-0217 16 inch aerosol endoscopic rigid tipThis brochure presented to demonstrate the surgical technique utilized by Samer Matter, M.D., Indianapolis, IN. Biomet Biologics, Inc., asthe manufacturer of this device, does not practice medicine and does not recommend this or any other system for use on a specific patient.The surgeon who performs any procedure is responsible for determining and utilizing the appropriate techniques for such procedure for useon a specific patient. Biomet Biologics, Inc. is not responsible for selection of the appropriate product or surgical technique to be utilized foran individual patient.This surgical technique is presented to demonstrate the use of the Plasmax ®Plasma Concentrateion System during Laparoscopic Roux-enYGastric Bypass surgery and is not intended to be utilized as instructions for performing a gastric bypass procedure.

#1. Remove and discard cap and green packaging post.Slowly load blood-filled 60ml syringe (6ml of ACD-A mixedwith 54ml of patient’s whole blood) into center blood port#1. Unscrew and discard protective inner piece from whitecap tethered to port #1. Screw white cap onto port #1.Place platelet separator filled with anticoagulated blood ina Biomet Biologics centrifuge.3. BALANCE: Fill blue GPS counterbalance tube(800-0508) with 60ml of sterile saline/water (equalto amount of whole blood plus ACD-A dispensed inthe platelet separator). Place filled counterbalancedirectly opposite from the platelet separator in the centrifuge.4. SPIN: Close centrifuge lid. Set RPM to 3.2 (x 1,000) andthe time to 15 minutes. Press the start button. Once spinis complete, open centrifuge.5. EXTRACT PPP: Unscrew and save yellow cap onport #2. Connect 30ml syringe to port #2, invertplatelet separator, and extract exactly 25ml of PPP. Remove 30ml syringe from port #2, cap with a sterile syringecap, and set aside. Replace yellow cap on port #2.6. If PRP is desired, follow steps 7 – 8.7. SUSPEND PRP: Holding platelet separator in theupright position, shake vigorously for 30 seconds.8. EXTRACT PRP: Immediately after suspending theplatelets, unscrew red cap on port #3. Attach sterile10ml syringe to port #3 and extract PRP. Remove 10mlsyringe from port #3 and cap with a sterile syringe cap.This device is only approved for distribution outside the United States.Biomet ® and all other trademarks found herein are the property ofBiomet, Inc. or its subsidiaries.Authorized Representative:0086Biomet U.K., Ltd.Waterton Industrial EstateBridgend, South WalesCF31 3XA, U.K.“The information contained in this package insert was currenton the date this brochure was printed. However, the packageinsert may have been revised after that date. To obtain acurrent package insert, please contact Biomet at the contactinformation provided herein.”PROCEDURE TWO: Use the Plasmax Plus Plasma Concentratorto prepare platelet-poor plasma concentrate (PPPc).1. LOAD: Unscrew cap on por t #1. Slowly load the 25mlPPP collected in 30ml syringe into por t #1. Unscrewand discard protective inner piece from white captethered to port #1. Screw white cap onto port #1.2. MIX: Twist and piston the mixing paddle for 30seconds. Be sure to push and twist the paddle tothe floor of the Plasmax Plus Plasma Concentrator’supper chamber to saturate all the beads. Thereshould be no white beads visible. Place into centrifuge.3. BALANCE: Place the green Plasmax Plus counterbalance(800-0512) directly opposite from the Plasmax Plus Plasma concentrator in the centrifuge.4. SPIN: Close centrifuge lid and set RPM to 2.0 (x 1,000)and the time to 2 minutes. Press the start button.Once spin is complete, open centrifuge.5. EXTRACT PPPc: Unscrew red cap on por t #2 andextract PPPc using a sterile 10ml syringe. Remove 10mlsyringe from port #2, and cap with a sterile syringe cap.Comments regarding this device can be directed to Attn:Regulatory Dept., Biomet, Inc., P.O. Box 587, Warsaw, IN46581 USA, FAX: 574-372-3968.This brochure is for International use only. It is not for distribution in the United States.

References:1. See C, et al. Am J Surg 2002;183:533-8.2. Podnos YD, et al. Arch Surg 2003;138:957.3. Bielecki TM, et al. JGJS (Br) 2007;89-B:417-20.4. Hom, DB, et al. Arch Facial Plast Surg 2007;9:174-83.All trademarks herein are property of Biomet, Inc. or its subsidiaries unlessotherwise indicated.This material is intended for the sole use and benefit of the Biomet Biologics internationalsales force and surgeons, ONLY.This brochure is not intended for patients.For product information, including indications, contraindications, warnings, precautionsand potential adverse effects, see the package insert herein and Biomet Biologics TM websiteat www.biometbiologics.com.BIOLOGICS, INC.P.O. Box 587, Warsaw, IN 46581-0587 • 800.348.9500 ext. 1501©2008 Biomet Orthopedics, Inc. • www.biomet.comForm No. BIV0011.0 • REV021508