Artist Proof: Clotalyst. Autologous Serum Collection System

Transcription

1 Artist Proof: Clotalyst Autologous Serum Collection System

2 Clotalyst Autologous Serum The kit is designed for the preparation of autologous serum that is to be mixed with PRP and autograft or allograft for bone graft handling prior to application to an orthopedic surgical site. The Clotalyst Autologous Serum Collection System produces approximately 6ml of autologous serum from only 12ml of patients own citrated blood. The serum output can be mixed with platelet rich plasma (PRP) produced by the GPS III system.

3 Clotalyst Autologous Serum Platelet gel derived from the GPS III System in combination with Clotalyst Autologous Serum The Clotalyst Kit includes GPS III disposable and all components necessary to produce PRP. The Clotalyst System is designed to clot PRP in less than 15 seconds. The kit produces 6ml of PRP and 6ml of Clotalyst autologous serum.

4 Preparation of the Clotalyst Autologous Serum Step 1: Draw Draw 12ml of citrated blood in a 12ml syringe (1ml of anticoagulant (ACD-A) and 11ml of blood). Gently mix the whole blood and anticoagulant upon collection to prevent coagulation. Step 2: Load Remove Clotalyst reagent syringe from sterile pouch and attach plunger. Note: Leave grey stopper on opposite end of reagent syringe when attaching plunger. Remove grey stopper on reagent syringe. Unscrew blue cap on port No. 2 of disposable and attach reagent syringe. While holding the Clotalyst disposable vertically, inject all of reagent. Remove the reagent syringe from the disposable. Remove protective cover on white cap and discard. Screw the white cap onto port No. 2.

5 Technique (continued) Step 2: Load (continued) Unscrew red cap on port No. 3 and attach syringe containing 12ml of citrated blood. While holding disposable vertically, inject all blood. Remove the empty syringe. Remove protective cover on the white cap and discard. Screw white cap onto port No. 3.

6 Technique (continued) Step 3: Incubate Gently mix by inverting disposable at least 12 times (without producing foam). Preheat Clotalyst heater 10 minutes prior to use. Place disposable into Clotalyst heater. The glass beads inside the disposable should be distributed evenly when it is placed into the heater. Press the incubation button to start cycle. When the incubation cycle is complete (25 minutes), the heater will beep four times. Step 4: Spin Preparation At the end of the 25-minute incubation period, shake the Clotalyst disposable to dissolve any gel present.

7 Technique (continued) Step 4: Spin Preparation (Counter Balance) Place Clotalyst disposable in the centrifuge with the empty Clotalyst orange counterbalance ( ) in the opposite side of the centrifuge. Step 5: Spin Close centrifuge lid and set speed to 3200 RPMs and time to 5 minutes. Press green button to start centrifuge cycle. Once cycle is complete, press red button to open lid. Step 6: Autologous Serum Extraction Gently remove the disposable from the centrifuge without disturbing the stratified layers. Unscrew the yellow cap from the center port while holding the disposable vertically. Connect sterile 12ml syringe to the center port and slowly extract 5 to 6ml of autologous serum.

8 Technique (continued) Step 6: Autologous Serum Extraction (continued) To maximize harvest volume, the disposable may be tilted towards port No. 3 as autologous serum is extracted. Step 7: Storage Store Clotalyst autologous serum at C (64 78ºF) for up to 4 hours prior to use. Discard remaining serum if not used within the provided time frames.

9 Clotalyst System Ordering Information Clotalyst System Description Catalog Number Clotalyst Kit includes GPS III Separator with Blood Draw and Reagent Clotalyst Kit includes GPS III Mini Separator with Blood Draw and Reagent Clotalyst Heater (Heater Cord included) Clotalyst Non-Sterile Counterbalance (Not included in Clotalyst kit) Drucker 230 Volt 50-60Hz Centrifuge 755VES Accessories Description Catalog Number Blending Connector Tip Single Cannula (To be used with ST-3 TIP) ATM100 Autologous Mixer Tip (Non-spray) ATM100 ST-3 Tip (Ten Pack) ST-3 TIP Autologous Mixer Tip with Spray Tip Attachment ATM100 TIP

10 Biomet Biologics E. Bell Drive Date: 01/09 P.O. Box 587 Warsaw, Indiana USA ClOtAlyst Kit WitH GPs iii separator AtteNtiON OPerAtiNG surgeon NOte: FOr single Use ONly. Discard the entire disposable kit after use by an acceptable method for devices potentially contaminated with blood products. DesCriPtiON The Clotalyst Kit with GPS III Separator(s) contains Clotalyst and GPS III Separator(s), Clotalyst Reagent, ACD-A and blood draw accessories. The system produces autologous serum and autologous platelet-rich plasma (PRP). Additional equipment used in the processing are the Clotalyst Heater and Biomet Biologics centrifuge. MAteriAls Clotalyst separator The Clotalyst Separator consists of medical grade polymers, silicone, acrylic, polyester and borosilicate (glass beads) suitable for use in medical devices. Clotalyst reagent (66% v/v ethyl alcohol, U.s.P./25mM Calcium Chloride, U.s.P.) Clotalyst Reagent is supplied and manufactured by ThermoGenesis Corp., Rancho Cordova, CA, for Biomet Biologics, Warsaw, IN. Please contact ThermoGenesis Corp., Rancho Cordova, CA, at for further information regarding the reagent. the GPs iii separators and blood draw components The materials used for syringes, needles, tubing and GPS III Separators consist of medical grade polymers, elastomers and stainless steel suitable for use in medical devices. Blood-draw components, when supplied in this kit, are packaged, labeled and sterilized as indicated by the manufacturer s labeling. ACD-A (Anticoagulant Citrate Dextrose solution, solution A. U.s.P.) ACD-A is an anticoagulant supplied by Citra Anticoagulants, Inc., Braintree, MA, and manufactured by Cytosol Laboratories, Inc., Braintree, MA. For further information regarding ACD-A Anticoagulant, please contact the supplier at All Components in this Kit are latex-free Please note: the ACD-A and Clotalyst Reagent included in this kit are only for use with the Clotalyst Kit with GPS III Separators. indications The GPS III Separator is designed to be used for the safe and rapid preparation of autologous platelet-rich-plasma (PRP) from a small sample of blood at the patient s point of care. The PRP can be mixed with autograft or allograft bone prior to application to an orthopedic surgical site as deemed necessary by clinical use requirements. The Clotalyst Kit is designed for the preparation of autologous serum that is to be mixed with the PRP and autograft or allograft for bone graft handling prior to application to the orthopedic surgical site CONtrAiNDiCAtiONs 1. Use as a dialyzer or for dialysis with a dialysate. 2. Direct connection to patient s vascular system of circulating blood volume. WArNiNG AND PreCAUtiONs 1. Single use device. Do not reuse. 2. Use proper safety precautions to guard against needle sticks. 3. Do not use sterile components of this kit if package is opened or damaged. 4. Store Clotalyst serum at 18-26o C ( o F) for up to 4 hours prior to use. Discard remaining serum if not used within the provided time frames. 5. The surgeon is to be thoroughly familiar with the equipment and the surgical procedure prior to using this device. 6. The patient is to be made aware of the general risks associated with the treatment and possible adverse effects. 7. The autologous serum exhibits thrombin activity and therefore must not be injected into or otherwise allowed to enter the patient s vascular system. 8. The safety and effectiveness of the device for bone healing and hemostasis has not been established. 9. Follow manufacturers instructions when using a Biomet Biologics centrifuge (IEC centrifuge or the Drucker company centrifuge) and the Clotalyst Heater. Outcomes utilizing centrifuges or heaters from other manufactures are unknown. POssiBle ADVerse effects FrOM BlOOD DrAW 1. Damage to blood vessels, hematoma, delayed wound healing and/or infection. 2. Temporary or permanent nerve damage that may result in pain or numbness. 3. Early or late postoperative infection. sterility The Clotalyst and GPS III Separators are terminally sterilized by exposure to a minimum dose of 25 kgy gamma radiations. All other components supplied in this system are sterilized by their respective suppliers using radiation or ethylene oxide gas (ETO). Do not re-sterilize. Do not use after expiration date. instructions FOr Use store serum at 18-26º C ( º F) for up to 4 hours prior to use. Use standard aseptic technique throughout the following procedures. PrOCeDUre ONe: Use of GPs iii separator (standard size) to prepare platelet-rich plasma (PrP)(Figure 1) 1. DrAW: Draw 6ml ACD-A into 60ml syringe. Attach to 18-gauge apheresis needle and prime with ACD-A. Slowly draw 54ml of the patient s blood into the 60ml syringe primed with ACD-A. Gently, but thoroughly, mix the whole blood and ACD-A upon collection to prevent coagulation. 2. load: ensure BlOOD FrOM ONly ONe PAtieNt is PrOCesseD Per spin, and that the GPs iii separator remains upright. Unscrew cap connected on center port #1. Remove and discard cap and green packaging post. Slowly load blood filled 60ml syringe (6ml ACD-A mixed with 54ml of the patient s whole blood) into center port #1. Unscrew and discard protective inner piece from white cap tethered to port #1. Screw white cap onto port #1. Place GPS III Separator filled with anticoagulated blood in a Biomet Biologics centrifuge. 3. BAlANCe: Fill blue GPS counterbalance tube ( ) with 35-60ml of sterile saline/water (equal to amount of whole blood plus ACD-A dispensed in the platelet concentrator). Place filled counterbalance directly opposite from the GPS III Separator in the centrifuge. 4. spin: Close centrifuge lid. Set RPM to 3.2 (x1000) and the time to 15 minutes. Press the start button. Once spin is complete, open the centrifuge and remove the GPS III Separator. 5. extract PPP: Unscrew and save yellow cap on port #2. Connect 30ml syringe to port #2, invert GPS III Separator, and extract platelet-poor plasma (PPP). Remove 30ml syringe from port #2, cap with a sterile syringe cap and set aside. Replace yellow cap on port #2. 6. suspend PrP: Holding GPS III Separator in the upright position, unscrew red cap on port #3. Attach sterile 10ml syringe to port #3. Extract 2ml of PRP into the 10ml syringe. Leave the syringe attached. Shake GPS III Separator gently for 30 seconds. 7. extract PrP: Immediately after suspending the platelets, extract the remaining PRP into the attached 10ml syringe. Remove 10ml syringe form port #3 and cap with a sterile syringe cap. Port#1 Port #2 Draw Tube Double Buoy Figure 1 GPS III Separator Port #3 Tethered Cap on Port #2 Protective Inner Pieces/syringe Tip The information contained in this package insert was current on the date this brochure was printed. However, the package insert may have been revised after that date. To obtain a current package insert, please contact Biomet at the contact information provided herein.

11 PROCEDURE ONE: Use of GPS III Mini Separator to prepare platelet-rich plasma (PRP)(Figure 1) 1. DRAW: Draw 3ml ACD-A into 30ml syringe. Attach to 18-gauge apheresis needle and prime with ACD-A. Slowly draw 27ml of the patient s blood into the 30ml syringe primed with ACD-A. Gently, but thoroughly, mix the whole blood and ACD-A upon collection to prevent coagulation. 2. LOAD: ENSURE BLOOD FROM ONLY ONE PATIENT IS PROCESSED PER SPIN, and that the GPS III Mini Separator remains upright. Unscrew cap connected on center port #1. Remove and discard cap and green packaging post. Slowly load blood filled 30ml syringe (3ml ACD-A mixed with 27ml of the patient s whole blood) into center port #1. Unscrew and discard protective inner piece from white cap tethered to port #1. Screw white cap onto port #1. Place GPS III Mini Separator filled with anticoagulated blood in a Biomet Biologics centrifuge. 3. BALANCE: Fill blue GPS counterbalance tube ( ) with 30ml of sterile saline/water (equal to amount of whole blood plus ACD-A dispensed in the GPS III Mini Separator). Place filled counterbalance directly opposite from the GPS III Mini Separator in the centrifuge. 4. SPIN: Close centrifuge lid. Set RPM to 3.2 (x1000) and the time to 15 minutes. Press the start button. Once spin is complete, open the centrifuge and remove the GPS III Mini Separator. 5. EXTRACT PPP: Unscrew and save yellow cap on port #2. Connect 30ml syringe to port #2, invert GPS III Mini Separator, and extract platelet-poor plasma (PPP). Remove 30ml syringe from port #2, cap with a sterile syringe cap and set aside. Replace yellow cap on port #2. 6. SUSPEND PRP: Holding GPS III Mini Separator in the upright position, unscrew red cap on port #3. Attach sterile 10ml syringe to port #3. Extract 1ml of PRP into the 10ml syringe. Leave the syringe attached. Shake GPS III Mini Separator gently for 30 seconds. 7. EXTRACT PRP: Immediately after suspending the platelets, extract the remaining PRP into the attached 10ml syringe. Remove 10ml syringe form port #3 and cap with a sterile syringe cap. PROCEDURE TWO: Use the Clotalyst Separator to prepare the autologous serum (Figure 2) 1. TURN ON: The Clotalyst Heater to achieve the appropriate operating temperature 25 C (77 F). 2. DRAW: Draw 1ml ACD-A into a sterile 10ml syringe. Attach to the 18-gauge apheresis needle. Slowly draw 11ml of the patient s blood into the 10ml syringe primed with ACD-A. Gently, but thoroughly mix the whole blood and ACD-A upon collection to prevent coagulation. NOTE: The 10ml syringe provided has graduation markings to 12ml. 3. LOAD Clotalyst REAGENT: Ensure the Clotalyst Separator remains upright. Unscrew and discard blue cap on port #2, attach Clotalyst Reagent syringe and completely transfer contents (4 ml) through port #2. Remove and discard reagent syringe. Unscrew and discard protective inner piece from white cap tethered to port #2. Screw white cap onto port #2. NOTE: Dislodging duckbill valves attached to ports #2 and #3 of the Clotalyst Separator during steps 3 and 4 can occur. This is NOT detrimental to the procedure. 4. LOAD BLOOD: ENSURE BLOOD FROM ONLY ONE PATIENT IS PROCESSED Unscrew and discard red cap on port #3. Attach and slowly transfer contents of anticoagulated blood-filled syringe (1ml ACD-A mixed with 11ml of patient s whole blood) through port #3. Unscrew and discard protective inner piece from white cap tethered to port #3. Screw white cap onto port #3. 5. MIX: Without producing foam gently invert Clotalyst Separator 12 times to thoroughly mix the anticoagulated blood with the Clotalyst reagent and glass beads. 6. INCUBATE: Holding the Clotalyst Separator on its side ensures the glass beads are distributed evenly. Place the Clotalyst Separator in the heater and begin the incubation cycle (25 minutes at 25 C). 7. SHAKE: Remove Clotalyst Separator from the heater and shake vigorously for 5 second, thus dislodging and braking up any coagulum that may be present in the separator. Place the Clotalyst Separator in a Biomet Biologics centrifuge. 8. BALANCE: Place the orange Clotalyst counterbalance ( ) directly opposite from the Clotalyst Separator in the centrifuge. 9. SPIN: Close centrifuge lid. Set RPM to 3.2 (x 1,000) and the time to 5 minutes. Press the start button. Once the spin is completed, open the centrifuge. 10. EXTRACT SERUM: Gently remove the Clotalyst Separator without disturbing the stratified layers. Holding Clotalyst Separator upright unscrew and remove the yellow cap on center port #1. Attach a sterile 10ml syringe to center port # 1. To maximize serum volume output gently tilt Clotalyst Separator toward port #3 while slowly extracting 5-6ml serum Remove the 10ml syringe from center port #1 and attach sterile syringe cap NOTE: If the extraction tube becomes plugged prior to achieving 5-6ml of output, the Clotalyst Separator can be placed back in the centrifuge for one minute at 3200 RPMs to dislodge the clot, allowing the remaining serum to be extracted. 11. STORAGE: Store serum at C ( F) for up to 4 hours prior to use. Discard remaining serum if not used within the provided time frames. Figure 2 Clotalyst Separator Caution: Federal law (USA) limits this device to sale, distribution, or use by or on the order of a physician. Comments regarding this device can be directed to Attn: Regulatory Dept., Biomet, Inc., P.O. Box 587, Warsaw, IN USA, Fax: All trademarks herein are the property of Biomet, Inc., or its subsidiaries unless otherwise indicated. Manufacturer Date of Manufacture Do Not Reuse Consult Accompanying Documents UExpiry Date Sterilized using Ethylene Oxide Sterilized using Irradiation Sterile WEEE Device Port # 2 Duckbill Extraction Tube Sterilized using Aseptic Technique Sterilized using Steam or Dry Heat Catalogue Number Port # 1 Filter Port # 3 Tethered Cap Protective Inner Pieces/syringe Tip Glass Beads Lot Number The information contained in this package insert was current on the date this brochure was printed. However, the package insert may have been revised after that date. To obtain a current package insert, please contact Biomet at the contact information provided herein.

12 All trademarks herein are the property of Biomet, Inc. or its subsidiaries unless otherwise indicated. This material is intended for the sole use and benefit of the Biomet Biologics sales force and physicians. It is not to be redistributed, duplicated or disclosed without the express written consent of Biomet. For product information, including surgical techniques, indications, contraindications, warnings, precautions and potential adverse effects, see the Biomet Biologics website at P.O. Box 587, Warsaw, IN x Biomet Orthopedics biomet.com Form No. BBI REV053110