Clotalyst. Autologous Activation Solution. Surgical Technique

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1 Clotalyst Autologous Activation Solution Surgical Technique

2 Table of Contents Product Overview Processing Technique Ordering Information Indication... 14

3 1 Clotalyst Autologous Activation Solution Surgical Technique Clotalyst Activation Solution Autologous Activation Solution No pooled or bovine sources No risk of bovine spongiform encephalopathy (BSE) Eliminates potential source related coagulopathies User Friendly Minimal steps required for processing No heating step required No centrifugation steps required Reliable Consistently produces up to 10 ml of activation solution Clots platelet-rich plasma in less than 15 seconds Output stable up to four hours after preparation Convenient Design Single use disposable No additional mechanical processing required Total processing time of less than 20 minutes

4 2 Clotalyst Autologous Activation Solution Surgical Technique Clotalyst produces up to 10 ml of autologous activation solution from only 12 ml of patients own citrated blood. The activation solution produced is indicated for use in conjunction with platelet-rich-plasma to improve bone graft handling. This characteristic is due to the ability of the Clotalyst autologous activation solution to rapidly activate PRP and create a platelet gel which serves as the structural matrix for the bone graft material. Platelet gel derived from the GPS III System in combination with Clotalyst Activation Solution

5 3 Clotalyst Autologous Activation Solution Surgical Technique Processing Technique Figure 1 Figure 2 Preparation Draw 12 ml of citrated blood into a 20 ml syringe (1 ml anticoagulant (ACD-A) and 11 ml of blood) (Figure 1). Note: Gently mix the whole blood and ACD-A upon collection to prevent sample coagulation until processing. Remove the Clotalyst reagent syringe from the sterile packaging and attach the plunger (Figure 2). Note: Leave the grey stopper on the reagent syringe while attaching the plunger.

6 4 Clotalyst Autologous Activation Solution Surgical Technique Figure 3 Figure 4 Loading Remove grey stopper from the Clotalyst reagent syringe. Unscrew the blue cap and attach the Clotalyst reagent syringe (Figure 3). Note: Clotalyst reagent is not loaded during this processing step. With the Clotalyst reagent now attached to the top port, unscrew the red cap and attach the 20 ml syringe containing the blood sample to the port located on the side of the device (Figure 4). Note: It is critical to use the 20 ml syringe at this step to ensure the needed syringe volume for the reagent and blood to mix.

7 5 Clotalyst Autologous Activation Solution Surgical Technique Figure 5 Figure 6 Loading (cont.) With both the Clotalyst reagent and the citrated blood sample attached to the Clotalyst device, the system is now ready for pre-mix loading (Figure 5). Depress the Clotalyst reagent plunger to transfer the entire volume (4 ml) into the 20 ml syringe containing the citrated blood sample (Figure 6).

8 6 Clotalyst Autologous Activation Solution Surgical Technique Figure 7 Figure 8 Loading (cont.) Next depress the 20 ml syringe plunger to transfer the 16 ml blood mixture into the Clotalyst device (Figure 7). With the device loaded and in the upright position, confirm that the blood mixture level reaches the 16 ml graduation location on the Clotalyst device wall (Figure 8).

9 7 Clotalyst Autologous Activation Solution Surgical Technique Figure 9 Figure 10 Activation Remove both syringes from the Clotalyst device and replace each with the tethered cap attached to the port (Figure 9). Ensure all ports are capped and shake the device vigorously for 15 seconds (Figure 10). Note: Foaming of the blood mixture is typical after shaking the Clotalyst device.

10 8 Clotalyst Autologous Activation Solution Surgical Technique Figure 11 Figure 12 Activation (cont.) Place the Clotalyst device on a flat surface at room temperature for 15 minutes (Figure 11). Note: Ensure the 16 ml graduation is oriented so that it remains visible during this step. Aspiration Shake the Clotalyst device for five seconds to remove any coagulated blood from the device wall prior to the product aspiration (Figure 12).

11 9 Clotalyst Autologous Activation Solution Surgical Technique Figure 13 Figure 14 Aspiration (cont.) Holding the Clotalyst device in the upright position, remove the yellow cap and attach a 10 ml syringe. Steadily extract 4-10 ml of autologous clotting solution (Figure 13). After aspirating the desired volume remove the 10 ml syringe and cap with a sterile syringe tip (Figure 14).

12 10 Clotalyst Autologous Activation Solution Surgical Technique Ordering Information Clotalyst System Product Description Part Number Clotalyst /GPS III Mini & Reagent Clotalyst /GPS III Single Kit & Reagent Blood Draw Kit

13 11 Clotalyst Autologous Activation Solution Surgical Technique Hardware* Product Description Part Number Universal GPS Spare Bucket Kit 60 ml (2pk Green Buckets) 7436 GPS Mini Spare Bucket Kit (2 Purple Buckets) 7433 Centrifuge 115 V 50/60 HZ Drucker (set of 7433 and 7436 included) 755VES Aerosol Regulator without Vent GPS Non-Sterile Counterbalance (Blue) GPS Mini Non-Sterile Counterbalance (Purple)

14 12 Clotalyst Autologous Activation Solution Surgical Technique Ordering Information (cont.) Accessories Product Description Part Number Dual Spray Applicator Tip Dual Cannula Tip Malleable, 20 gauge diameter, 4 in length Dual Cannula Tip Malleable, 20 gauge, diameter, 7 in length Blending Connector Single Cannula Dual Lumen Endoscopic Tip Malleable, 5 mm diameter, 12 in length Manual Endoscopic Tip Rigid, 16 in length Endoscopic Aerosol Tip Rigid, 16 in length, Tubing included Arthroscopic Applicator Kit Tips included Manual Spray Applicator Kit Tips not included Aerosol Spray Applicator Kit Tips included

15 13 Clotalyst Autologous Activation Solution Surgical Technique Accessories Continued Product Description Part Number Graft Preparation System Storage Requirements Whole Blood Anticoagulant 8 12% ACD-A Storage Requirements When used immediately or within one hour: Store between C When used after one hour: Store between 2 6 C (up to 4 hours)

16 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 requirements. Contraindications: Use as a dialyzer or for dialysis with a dialysate. Direct connection to patient s vascular system of circulation blood volume. The Clotalyst Kit is designed for the preparation of autologous serum that is to be mixed with the PRP and autograft for bone graft handling prior to application to the orthopedic surgical site. All content herein is protected by copyright, trademarks and other intellectual property rights, as applicable, owned by or licensed to Zimmer Biomet or its affiliates unless otherwise indicated, and must not be redistributed, duplicated or disclosed, in whole or in part, without the express written consent of Zimmer Biomet. This material is intended for health care professionals. Distribution to any other recipient is prohibited. For product information, including indications, contraindications, warnings, precautions, potential adverse effects and patient counselling information, see the package insert and Zimmer Biomet US-en-REV0118 Legal Manufacturer Biomet Orthopedics P.O. Box E. Bell Drive Warsaw, Indiana USA zimmerbiomet.com

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