Angel cPRP System Processing Set Instructions for Use Sept 2013

Three-Compartment Reservoir Bag: The three-compartment reservoir bag is used to collect the anticoagulated whole blood, the mixture of blood and bone marrow, and separated blood components. The whole blood compartment is used as a reservoir for the collected anticoagulated whole blood/bone marrow from a patient. The clinician may use syringes or whole blood bags to collect the anticoagulated whole blood or mixture of blood and bone marrow from a patient. The RBC Compartment is used to collect the concentrated red cells at the end of the processing cycle. The PPP Compartment is used to collect platelet poor plasma; the PPP is the first blood component collected after separation has been completed. Syringe-activated valves are used to access the PPP, and whole blood compartments of the three-compartment reservoir bag. Other accessory items in the Angel® cPRP Processing Set are: 20 ml Luer Lock Syringe: The 20 ml luer lock syringe is used for the collection of platelet rich plasma. However, the syringe-activated PRP valve will accommodate most luer fitting syringes. 60 ml Wrapped Specimen Cups (2 ea.): For use in collecting samples of the separated platelet poor plasma and platelet rich plasma as needed. Male/Female Luer Plug: The male/female luer plug can be used during and at the end of the procedure to seal open luer lock connections. Whole Blood Bag Spike Adapter: The whole blood spike adapter is used to transfer blood from a whole blood bag to the whole blood compartment of the three-compartment reservoir bag. Labels: Appropriate labels to label collected whole blood and separated components. DESCRIPTION The Cytomedix™ 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). The Angel® cPRP Processing Set also contains a 20 ml luer lock syringe for the collection of platelet rich plasma (PRP), two 60 ml specimen cups for collecting samples of the blood components, as needed, a whole blood bag spike adapter, a male-female luer plug, and labels for collected blood components. Contents of this set have been sterilized by ethylene oxide gas and have nonpyrogenic fluid pathways. INDICATIONS FOR USE The Angel® Concentrated Platelet Rich Plasma (cPRP) System, is intended to be used in the clinical laboratory or intraoperatively at the point-of-care for the safe and rapid preparation of platelet poor plasma and concentrate (platelet rich plasma) from a small sample of whole blood or a small mixture of blood and bone marrow. The platelet rich plasma from the Angel® Concentrated Platelet Rich Plasma (cPRP) System can also be mixed with autograft and/or allograft bone prior to application to an orthopedic site. 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 The Angel® cPRP Processing Set may be contraindicated in cases where there is active systemic infection or systemic heparinization. WARNINGS 1.

Only Angel® cPRP Processing Sets are approved for patient use with the Angel® Concentrated Platelet Rich Plasma (cPRP) System.

2. Do not use the Angel® cPRP Processing Set if the sterile packaging barrier has been broken. 3. Carefully examine the Angel® cPRP Processing Set for damage prior to use. Should any evidence of damage to the Processing Set be evident, do not use the Processing Set. 4. Carefully observe the Angel® cPRP Processing Set for leaks during use. Leakage may result in loss of sterility of the device or loss of blood product. 5. When collecting and processing autologous blood products or a mixture of blood and bone marrow it is recommended that the following precautions be followed to ensure that the autologous product is not contaminated. A. Use sterile technique when setting up the Angel® cPRP Processing Set B. Thoroughly clean and disinfect the donation site C. Use sterile technique whenever handling autologous blood products 6. The whole blood or mixture of blood and bone marrow must be anticoagulated before it can be processed for separation. Inadequate anticoagulation may result in clotting, interfering with the processing of the blood products. Blood/bone marrow containing clots will not pass through the syringe-activated valve located on the Whole Blood compartment of the three-compartment reservoir bag. 7. If centrifugation is discontinued before the completion of a processing cycle, the variable volume separation chamber is pressurized and presents the risk for exposure to blood and blood-borne pathogens if the variable volume separation chamber is not properly removed. Please refer to the Angel® Concentrated Platelet Rich Plasma (cPRP) System Operator’s Manual for unloading a variable volume separation chamber containing blood. 8.

Failure to properly secure the luer lock syringe to the syringe-activated valve on the valve assembly may result in a leakage of fluids.

9. Do not directly connect the patient to the three-compartment reservoir bag. Direct connection to the patient could lead to vascular damage, shock or air embolism. IFU011644/03 Cytomedix, Inc.

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10. Disposal of Angel® cPRP Processing Sets should be in accordance with federal, state, and local regulations. These 10. Disposal of Angel® Whole Blood Separation Processing Sets should be in accordance with federal, state, and local materials should be considered biohazardous. Universal precautions for blood-borne pathogens should be practiced regulations. Theseofmaterials should be considered biohazardous. Universal precautions for blood borne pathogens when disposing these items. should be practiced when disposing of these items. ® ® Concentrated Platelet Rich Plasma (cPRP) System on a flat, stable surface. Never try to move the 11.Place Angel Placethe theAngel Whole Blood Separation System on a flat, stable surface. Never try to move the Angel® Whole Blood 11. ® Concentrated Platelet Rich Plasma (cPRP) System while the device is in operation. Angel Separation System while the device is in operation. 12. forfor transfusion. Theplatelet plateletrich richplasma plasmais isnot notintended intended transfusion. 12.The PRECAUTIONS PRECAUTIONS ® ® 1.13.Carefully Use before beforeusing usingthis thisproduct. product. Refer to the Angel Whole Blood Separation Concentrated Platelet Rich Angel Carefullyread readthese these Instructions Instructions for for Use Refer to the System ManualOperator’s for complete instructions. PlasmaOperator’s (cPRP) System Manual for complete instructions

borne pathogens HIV, hepatitis hepatitis viruses, viruses,bacteria, bacteria,etc.), etc.), 2.14.Due Duetotothe thepossibility possibilityofofoperator operatorexposure exposureto to blood blood-borne pathogens (such (such as as HIV, Universal Precautions for blood borne pathogens should be practiced. Universal Precautions for blood-borne pathogens should be practiced. 3. The Angel® ®Whole Blood Separation Processing Set is intended for single use. Do not resterilize any part of this cPRP Processing Set is intended for single use. Do not resterilize any part of this Processing Set. The AngelSet. 15.Processing

® Failuretotoproperly properly load Processing Set per theProcessing enclosed instructions mayenclosed affect theinstructions performancemay of the system. 4.16.Failure load the theAngel Angel®cPRP Whole Blood Separation Set per the affect the performance of the system. 17. Luer lock syringes should be used with the Angel® cPRP Processing Set. 5. Luer lock syringes should be used with the Angel® Whole Blood Separation Processing Set. 18. This product is intended for use by trained medical personnel only. 6. This product is intended for use by trained personnel only. 19. Caution: Federal law (USA) restricts this device to sale by or on the order of a physician. 7. Caution: Federal law (USA) restricts this device to sale by or on the order of a physician. thisdevice deviceforforinin-vivo indications use has not been established. Thesafety safetyand andeffectiveness effectivenessofofthis 8.20.The vivo indications forfor use has not been established.

INSTRUCTIONS FOR USE INSTRUCTIONS FOR USE ® Turning Turningon onthe theAngel Angel® cPRP System ®® Blood Separation System by pressing the power on the the power back ofswitch the machine. The of the Turn Concentrated Platelet Rich Plasma (cPRP) System by switch pressing on the back Turnononthe theAngel AngelWhole cPRP System’s touch machine.“Self Thetest message “Self test in progress. Please by.” will thescreen Angel®display, touch and the machine message in progress. Please stand by.” will bestand displayed on be thedisplayed Angel®’s on screen display, and the machinedriver will orientate the valve assembly driver to the loading position. will orientate the valve assembly to the loading position.

Initial Setup Initial Setup ® ® cPRPon, System on, do the following: Withthe theAngel Angel turned do theturned following: With

Openthe thecentrifuge centrifugelidlidcover cover and the centrifuge stator arm lock the centrifuge adapter within the centrifuge well. 1.1. Open and liftlift the centrifuge stator arm toto lock the centrifuge adapter within the centrifuge well. 2. Remove the Angel® cPRP Processing Set from the tray. 2. Remove the Angel® Whole Blood Separation Processing Set from the tray.

® 2 - Rear-view of® Angel Whole Blood Separation System Concentrated Platelet Rich Plasma (cPRP) System Figure 2Figure – Rear-view of Angel ® 3.3. Lay Separation Processing the top the machine. the variable volume ® Laythe theAngel AngelWhole cPRPBlood Processing Set on the top of Disposables the machine.on Insert the of variable volumeInsert separation chamber in separation chamber into the centrifuge adapter by aligning the notches in the separation chamber plate with the the centrifuge adapter by aligning the notches in the separation chamber plate down near the location of the position aligning feature on the centrifuge adapter. Once aligned, press the separation chamber plate down near the location indicator and turn clockwise until the position indicator snaps into place (see Figure 3). of the position indicator and turn clockwise until the position indicator snaps into place (see Figure 3). Rotate the centrifuge position that interlock mechanism shown Figure item 2 does interfere with Rotate the centrifuge to to aa position soso that thethe interlock mechanism shown in in Figure 3, 2, item 2 does notnot interfere with thethe stator arm. If the interlock mechanism interferes with the stator arm, the separation chamber plate will not load properly. stator arm. If the interlock mechanism interferes with the stator arm the separation chamber plate will not load properly.

Note: Note:Loading Loadingthe thevariable variablevolume volumeseparation separationchamber chambershould shouldalways alwaysbe bethe thefirst firststep stepin in the the setup setup process. process. Loading Loading thevariable variablevolume volumeseparation separationchamber chamberand andpressing pressingdown downon on the the separation separation chamber plate will remove excess the excess air air volumefrom fromthe the chamber.If Ifexcess excessairairis isnot notremoved, removed,the theseparation separationchamber chamber plate will not load properly. volume chamber. plate will not load properly. IFU011644/02 Cytomedix, nc. IFU011644/03 Cytomedix, Inc. Inc. Cytomedix,

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1 1 2 2 3 3

Separation Chamber Plate Separation Chamber Plate Separation Chamber Plate Separation Chamber Plate Interlock Mechanism Interlock Mechanism Position Indicators Position Indicators

Figure33- –Mounting Mounting Separation Chamber Figure thethe Separation Chamber Figure 3 - Mounting the Separation Chamber 4.4. Place volume separation chamber through the slot onon the rim ofof the centrifuge well. Placethe thetube tubeleading leadingfrom fromthe thevariable variable volume separation chamber through the slot the rim the centrifuge well. 4. Place the tube leading from the variable volume separation chamber through the slot on the rim of the centrifuge well. Lowerthe thecentrifuge centrifugestator statorarm armand andalign alignitit with with the the raised raised tab tab on 5.5. Lower on the the top top of of the therotating rotatingseal sealofofthe thevariable variablevolume volume 5. separation Lower the centrifuge stator arm and align it with the raised tab on the top of the rotating seal of the variable volume separation chamber (Figure 4). chamber (Figure 4). separation chamber (Figure 4).

Figure 4 - Centrifuge stator arm aligned with the variable volume separation chamber Figure 4 - Centrifuge stator arm aligned with the variable volume separation chamber

Figure 4 – Centrifuge stator arm aligned with the variable volume separation chamber 6. Close the centrifuge lid. After closing the centrifuge lid, make sure that the tubing remains in the slot on the rim of the 6. centrifuge Close the centrifuge After closing the centrifuge make sure that the tubing remains in the slot on the rim of the is not lid. occluded the centrifuge lid. lid, closing the centrifuge Close theand centrifuge lid. Afterby 6. centrifuge and is not occluded by the centrifuge lid. lid, make sure that the tubing remains in the slot on the rim of the centrifuge and is not occluded by the centrifuge lid. 7. Place the pump loop tubing over the pump rotor. The pump loop will automatically load when the processing cycle is 7.7. initiated. Place pump loop tubing over rotor. automatically the processing cyclethe is iniSeat the platelet cuvette/valve assembly by pump aligning thewill platelet cuvette load and when the valve assembly with Placethe the pump loop tubing overthe thepump pump rotor.The The pump loop loop will automatically load when the processing cycle is initiated. Seat the platelet cuvette/valve assembly by aligning the platelet cuvette and the valve assembly with the platelet body and cuvette/valve the valve assembly driver. Press down firmly on the back sidevalve of theassembly platelet cuvette/valve tiated. sensor Seat the platelet assembly by aligning the platelet cuvette and the with the platelet platelet body theassembly valve assembly driver. Press downonfirmly on the side of the platelet cuvette/valve assembly, at position A near the pump loop,Press until the assembly isthe snapped inback place (label A,cuvette/valve Figure 5). Note: It is sensorsensor body and theand valve driver. down firmly back side of the platelet assembly, is place snapped inA, place (label A, Figure 5). Note:that It isthe assembly, atAposition Apump near loop, the pump loop, until the at position near thecuvette/valve until the assembly is assembly snapped in (label Figure 5). Note: It iscomponents. essential essential that platelet assembly seats fully on machine to obtain proper sensing of blood essential platelet cuvette/valve assembly fully on machine obtainsensing proper sensing blood components. platelet that cuvette/valve assembly seats fully onseats the machine to obtaintoproper of blood of components.

IFU011644/02 Cytomedix,2c. IFU011644/02 Cytomedix,2c. Cytomedix, Inc. IFU011644/03 Cytomedix, Cytomedix, Inc. Inc.

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1

Platelet Cuvette

2

Valve Assembly

3

Valve Assembly Driver

4

Syringe-Activated PRP Valve

Figure – Valve Assembly Figure 5 -5Valve Assembly 8. Hang the three-compartment reservoir bag on the two support pins located on the side of the Angel® Whole Blood 8. Separation Hang the three-compartment reservoir bag on two support pins located on the side of the Angel® Concentrated Platelet System. Rich Plasma (cPRP) System. 9. Remove breather cap from PRP valve port located on the valve assembly. If desired, attach the Syringe Activated 9. Valve valve port located on the (or valve assembly. If desired, attachtothe Remove the breather PRPthe to the PRP valve cap port.from Attach 20 ml luer lock syringe alternate syringe, if desired), thesyringe-activated PRP valve port. valve to the PRP valve port. Attach the 20 ml luer lock syringe (or alternate syringe, if desired), to the PRP valve port. Note: The luer on the PRP valve port will accommodate most luer lock syringes. Note: The luer on the PRP valve port will accommodate most luer lock syringes. 10. After set-up, inspect the circuit to make sure there are no kinks or occlusions. 10. After set-up, inspect the circuit to make sure there are no kinks or occlusions. Blood BloodCollection Collection ® Blood Separation System utilizes a variable volumeaseparation chamber that is chamber capable of processing The TheAngel Angel®Whole Concentrated Platelet Rich Plasma (cPRP) System utilizes variable volume separation that is capable of between 40 ml and 180 ml of anticoagulated whole blood in a single cycle. processing between 40 ml and 180 ml of anticoagulated whole blood or a mixture of blood and bone marrow in a single cycle. ® Blood Separation System can(cPRP) accommodate anticoagulated whole blood that whole has been collected The TheAngel Angel®Whole Concentrated Platelet Rich Plasma System can accommodate anticoagulated blood that hasin either In collection either situation, the whole blood should be collected in a citrate anticoagulant beensyringes collectedorinblood eithercollection syringes bags. or blood bags. In either situation, the whole blood should be collected in a citrate (ACD-A) in a 7:1(ACD-A) ratio (seven parts whole blood to one part citrate anticoagulant The following the anticoagulant in a 7:1 ratio (seven parts whole blood to one part citrate(ACD-A)). anticoagulant (ACD-A)).table The defines following table appropriate of whole bloodofand citrate anticoagulant (ACD-A): defines themixture appropriate mixture whole blood and citrate anticoagulant (ACD-A):

Whole Blood Citrate Anticoagulant Mixture Whole Blood vs.vs. Citrate Anticoagulant Mixture (7:1 ratio: seven parts blood to one part citrate anticoagulant) (7:1 ratio; seven parts blood to one part citrate anticoagulant) Total Volume of Total Volume of TotalWhole Volume of (ml) TotalWhole Volume of Drawn (ml) Volume of ACD-A (ml) Blood Anticoagulated Blood Volume of ACD-A (ml) Anticoagulatedi Whole Blood(ml) Whole Blood Drawn (ml) 40 i 5 35 5 35 40 50 6 44 50 6 44 60 52 60 8 8 52 70 61 70 9 9 61 10 10 12 12 13 13 14 14 15 15 16 18 16 19 18

20 19 21 20 23 21

70 78 87 96 105 114 122 131 140 149 157

70

78 87 96 105 114 122 131 140 149

40 ml anticoagulated 180 whole blood volumes require a patient 23 hematocrit of 30% or greater. The recommended 157 minimum patient hematocrit for anticoagulated whole blood volumes of 50 ml or greater is 28%. i

i

80 80 90 90 100 100 110 110 120 120 130 130 140 140 150 150 160 170 160 180 170

40 ml anticoagulated whole blood volumes require a patient hematocrit of 30% or greater. The recom-

IFU011644/02 Cytomedix,mended Inc. minimum patient hematocrit for anticoagulated whole blood volumes of 50 ml or greater is 28%. Cytomedix, Inc.

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During and after collection, gently mix the whole blood or mixture of blood and bone marrow with the citrate anticoagulant for a thorough distribution of the anticoagulant. Failure to properly mix the collected blood or mixture of blood and bone marrow with anticoagulant may cause blood clot formation. Blood clot formation may interfere with the loading of the blood or blood/bone marrow mixture into the Whole Blood compartment of the three-compartment reservoir bag and/or may interfere with the processing of the blood or the mixture of blood and bone marrow. If a syringe is used to collect the blood or blood and bone marrow mixture, attach the syringe to the syringe-activated valve located on the Whole Blood compartment of the three-compartment reservoir bag and inject the blood or mixture of blood and bone marrow. If using a whole blood collection bag to collect blood, ensure that the blood-citrate ratio is correct by weighing the bag as the blood is collected according to AABB standard methods.1 Place the citrated (ACD-A) blood bank bag on a standard metric scale and zero it prior to beginning to withdraw the blood. Refer to the instructions for the specific bag that you are using and allow the blood to gravity drain into the bag until its weight equals the volume of the bag (1 ml of blood weighs approximately 1.053 grams). If a mixture of blood and bone marrow is to be processed using the Angel® Concentrated Platelet Rich Plasma (cPRP) System, samples of a patient’s bone marrow should be obtained using the techniques and procedures as practiced at each individual hospital or health-care setting. Equal volumes of anti-coagulated whole blood and bone marrow can be transferred into the whole blood compartment of the three-compartment reservoir bag using the syringe-activated valve or Whole Blood Bag Spike Adapter. Use the Whole Blood Bag Spike Adapter to transfer the blood or the mixture of blood and bone marrow to the whole blood compartment of the three-compartment reservoir bag. Connect the Whole Blood Bag Spike Adapter to the syringe-activated valve located on the Whole Blood compartment of the three-compartment reservoir bag and spike the blood collection bag to drain the blood or the mixture of blood and bone marrow into the whole blood compartment. After the blood has drained into the Whole Blood compartment of the threecompartment reservoir bag, remove the Whole Blood Bag Spike Adapter and recap the syringe-activated valve. Refer to the Angel® Concentrated Platelet Rich Plasma (cPRP) System Operator’s Manual for processing instructions. Method 9.3 Phlebotomy and Collection. Technical Manual. American Association of Blood Banks. AABB Press. Bethesda, MD. 1996.

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RETURN OF USED PRODUCT For Customers Within the United States If for any reason this product must be returned to Cytomedix, Inc., a returned goods authorization (RGA) number is required from Cytomedix, Inc., prior to shipping. If the product has been in contact with blood or body fluids, it must be thoroughly cleaned and disinfected before packing. It should be shipped in either the original carton, or an equivalent carton, to prevent damage during shipment; and it should be properly labeled with an RGA number and an indication of the biohazardous nature of the contents of the shipment. Instructions for cleaning and materials, including appropriate shipping containers, proper labeling, and an RGA number may be obtained from Cytomedix, Inc., Customer Care Department (866-298-6633). CAUTION It is the responsibility of the health care institution to adequately prepare and identify the product for return shipment. Do not return products that have been exposed to blood-borne infection diseases. The shipping address for returned goods is: Cytomedix, Inc. 209 Perry Parkway, Suite 7 Gathersburg, MD 20877, USA For Customers Outside the United States If for any reason this product must be returned, please contact your sales representative for specific instructions. If the product has been in contact with blood or body fluids, it must be thoroughly cleaned and disinfected before packing. It should be shipped in either the original carton, or an equivalent carton, to prevent damage during shipment. CAUTION It is the responsibility of the health care institution to adequately prepare and identify the product for return shipment. Do not return products that have been exposed to blood-borne infectious diseases. LIMITED WARRANTY CYTOMEDIX warrants that all reasonable care has been taken in the manufacture of the Cytomedix™ Angel® cPRP Processing Set as required by the nature of the system and the use for which the system is intended. CYTOMEDIX warrants that the Cytomedix™ Angel® cPRP Processing Set is capable of functioning as indicated in the current Instructions for Use when used in accordance with such instructions by a qualified medical professional and before any expiration date indicated on the packaging. CYTOMEDIX makes no guarantee that: (1) a user of the Cytomedix™ Angel® cPRP Processing Set will use the system correctly, or (2) an incorrect diagnosis or therapy and/or the particular physical and biological haematological characteristics of an individual patient, do not affect the performance and effectiveness of the system with damaging consequences for the patient, even though the specified Instructions for Use have been respected, and CYTOMEDIX hereby disclaims any liability or responsibility for any such consequences resulting therefrom. CYTOMEDIX, assumes no responsibility for any loss, damage, expense, incidents or consequences arising directly or indirectly from the improper use of the Cytomedix™ Angel® cPRP Processing Set. CYTOMEDIX hereby emphasizes that users must adhere strictly to the Instructions for Use of the system and follow all precautions necessary for the correct use of the system. CYTOMEDIX undertakes to replace any defective component of the Cytomedix™ Angel® cPRP Processing Set in the event that it is defective when shipped by CYTOMEDIX up to the time of delivery to the final user unless such defect has been caused by mishandling by the purchaser or the passage of any expiration date indicated on the packaging. All products are guaranteed for a period of 12 months starting on the date of installation and, in any event, for not more than 13 months starting on the date of dispatch, even when, in this latter case, the period of installation of the equipment is less than 12 months. The above replaces all other warranties explicit or implicit, written or verbal, including warranties of merchantability and fitness for a particular purpose. No person, including any representative, agent, dealer, distributor or intermediary of CYTOMEDIX or any other industrial or commercial organization is authorized to make any representation or warranty concerning this medical device except as expressly stated herein. Except for the warranties expressly stated herein, CYTOMEDIX hereby disclaims and excludes all other warranties, express or implied, including, without limitation, the implied warranties of merchantability and/or fitness for a particular purpose. IFU011644/03 Cytomedix, Inc.

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CYTOMEDIX hereby disclaims and excludes all other warranties, express or implied, including, without limitation, the implied warranties of merchantability and/or fitness for a particular purpose. The purchaser undertakes to comply and cause any user to comply with the terms of this Limited Warranty and agrees, in The purchaser undertakes to comply andregard cause to anythe user to comply with the ®terms of this Limited WarrantyProcessing and agrees,Set, in the Whole Blood Separation notevent to the event of a dispute or litigation with Cytomedix™ Angel ® cPRP Processing Set,made not to to make based on any alleged or of a dispute or litigation with regard to the Cytomedix™ Angel make claims based on any alleged or proposed changes or alterations thisclaims Limited Warranty by any proposed changes or alterations made to this Limited Warranty. of CYTOMEDIX in violation of the terms hereof. representative, agent, dealer, distributor or other intermediary This contract shall be governed by and construed in accordance with the domestic laws of the State of Maryland without This contract shall be governed by and construed in accordance with the domestic laws of the State of Maryland without giving effect giving choice or provision conflict oforlaw orthe ruleState (whether of theorState of Maryland or any other cause jurisdiction) to anyeffect choicetoorany conflict of law ruleprovision (whether of of Maryland any other jurisdiction) that would the that would cause the application of the laws of any jurisdiction other than the State of Maryland. application of the laws of any jurisdiction other than the State of Maryland. Any action or proceeding seeking to enforce any provision of, or based on any right arising out of, this contract, including the terms oforthe Limited Warranty forthany herein, may of, beorbrought only the arising courts out of the State of Maryland, Any action proceeding seeking toset enforce provision based on anyinright of, this Limited Warranty,county may beof Montgomery, or,the if courts it has of orthe canState acquire jurisdiction, in of the United States for thejurisdiction, District ofinMaryland, brought only in of Maryland, county Montgomery, or, if District it has orCourt can acquire the United and States District Court for thehereto Districtconsents of Maryland, andjurisdiction by your useofofsuch the system, you acknowledge your consent to the jurisdiction of such each of the parties to the courts (and of the appropriate appellate courts) in any courtsor(and of the appropriate appellate courts) in any such action or proceeding andin waive objection to venue laid therein. and waives any objection to venue laid therein. Process any any action or proceeding referred to in action proceeding Process in any action ormay proceeding referred to inparty the preceding sentence in may served anywhere in the world. the preceding sentence be served on any hereto anywhere thebe world. DEFINITION SYMBOLS used in product labeling) DEFINITION OFOF SYMBOLS (as(as used in product labeling) DEFINITION OF SYMBOLS (as used in product labeling) FOR SINGLE USE ONLY (DO NOT REUSE) FOR SINGLE USE ONLY (DO NOT REUSE) BATCH CODE (NUMBER) (REFERENCE PRODUCT BATCH CODE FOR (NUMBER) TRACEABILITY) (REFERENCE FOR PRODUCT TRACEABILITY) USE BY (EXPIRY DATE) USE BY (EXPIRY DATE) DATE OF MANUFACTURE DATE OF MANUFACTURE STERILE - ETHYLENE OXIDE STERILIZED STERILE - ETHYLENE OXIDE STERILISED NON PYROGENIC NON PYROGENIC CONTAINS PHTHALATE CONTAINS PHTHALATE LATEX FREE LATEX FREE CAUTION: FEDERAL LAW (USA)

RESTRICTS THIS DEVICE TO SALE BY CAUTION: FEDERAL LAW (USA) OR ON THE ORDER OF A PHYSICIAN. RESTRICT THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN. WARNING: DO NOT RESTERILIZE. WARNING: DO NOT RESTERILIZE. CONTENTS STERILE ONLY IF PACKAGE IS NOT OPENED, DAMAGED CONTENTS STERILE ONLY IF PACKAGE IS OR BROKEN NOT OPENED, DAMAGED OR BROKEN CATALOGUE (CODE) NUMBER CATALOGUE (CODE) NUMBER QUANTITY ea QUANTITY ea

ATTENTION, SEE INSTRUCTION FOR USE ATTENTION, SEE INSTRUCTION FOR USE THIS WAY UP THIS WAY UP FRAGILE; HANDLE WITH CARE FRAGILE; HANDLE WITH CARE KEEP AWAY FROM HEAT KEEP AWAY FROM HEAT KEEP DRY KEEP DRY MANUFACTURER

IFU011644/02 Cytomedix, Inc. Cytomedix, Inc.

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