clotalyst® autologous activation solution surgical technique

Clotalyst®

Autologous Activation Solution

Surgical Technique

Table of Contents

Product Overview .................................................................................................. 1-2

Processing Technique ............................................................................................3-9

Ordering Information ........................................................................................ 10-13

Indication ................................................................................................................ 14

1 | Clotalyst® Autologous Activation Solution Surgical Technique

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

Clotalyst® Activation Solution


Platelet gel derived from the GPS® III System in combination with Clotalyst® Activation Solution

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.


Figure 1

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.

Figure 2

Processing Technique


Figure 3

LoadingRemove 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.

Figure 4


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).

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).

Figure 6


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).

Figure 8

Loading (cont.)

Next depress the 20 ml syringe plunger to transfer the 16 ml blood mixture into the Clotalyst® device (Figure 7).


Figure 9

ActivationRemove 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.

Figure 10


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.

AspirationShake the Clotalyst® device for five seconds to remove any coagulated blood from the device wall prior to the product aspiration (Figure 12).


After aspirating the desired volume remove the 10 ml syringe and cap with a sterile syringe tip (Figure 14).

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).

Figure 13


Clotalyst® System

Product Description Part Number

Clotalyst®/GPS III Mini & Reagent 800-0724

Clotalyst®/GPS III Single Kit & Reagent 800-0726

Blood Draw Kit 800-0401

Ordering Information


Hardware*


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 800-0211

GPS® Non-Sterile Counterbalance (Blue)

800-0508

GPS® Mini Non-Sterile Counterbalance (Purple)

800-0505


Accessories


Dual Spray Applicator Tip 800-0201

Dual Cannula Tip Malleable, 20 gauge diameter, 4 in length

800-0202

Dual Cannula Tip Malleable, 20 gauge, diameter, 7 in length

800-0203

Blending ConnectorSingle Cannula

800-0204

Dual Lumen Endoscopic TipMalleable, 5 mm diameter, 12 in length

800-0207

Manual Endoscopic TipRigid, 16 in length

800-0208

Endoscopic Aerosol Tip Rigid, 16 in length, Tubing included

800-0217

Arthroscopic Applicator Kit Tips included

800-0225

Manual Spray Applicator Kit Tips not included

800-0250

Aerosol Spray Applicator Kit Tips included

800-0260

Ordering Information (cont.)


Accessories Continued


Graft Preparation System 800-0300

Storage Requirements

Whole Blood

Anticoagulant 8 — 12% ACD-A

Storage Requirements When used immediately or within one hour:Store between 18 — 26°C

When used after one hour: Store between 2 — 6°C (up to 4 hours)

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.

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 www.zimmerbiomet.com.

©2018 Zimmer Biomet.

1793.1-US-en-REV0118

Legal ManufacturerBiomet Orthopedics P.O. Box 58756 E. Bell DriveWarsaw, Indiana 46581-0587 USA

zimmerbiomet.com

Contraindications:Use as a dialyzer or for dialysis with a dialysate. Direct connection to patient’s vascular system of circulation blood volume.

clotalyst® autologous activation solution surgical technique

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