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
2 | Clotalyst® Autologous Activation Solution Surgical Technique
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.
3 | Clotalyst® Autologous Activation Solution Surgical Technique
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
4 | Clotalyst® Autologous Activation Solution Surgical 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
5 | Clotalyst® Autologous Activation Solution Surgical Technique
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
6 | Clotalyst® Autologous Activation Solution Surgical Technique
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).
7 | Clotalyst® Autologous Activation Solution Surgical Technique
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
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.
AspirationShake the Clotalyst® device for five seconds to remove any coagulated blood from the device wall prior to the product aspiration (Figure 12).
9 | Clotalyst® Autologous Activation Solution Surgical Technique
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
10 | Clotalyst® Autologous Activation Solution Surgical Technique
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
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 800-0211
GPS® Non-Sterile Counterbalance (Blue)
800-0508
GPS® Mini Non-Sterile Counterbalance (Purple)
800-0505
12 | Clotalyst® Autologous Activation Solution Surgical Technique
Accessories
Product Description Part Number
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.)
13 | Clotalyst® Autologous Activation Solution Surgical Technique
Accessories Continued
Product Description Part Number
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.
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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.