PurePRP® SupraPhysiologic Concentrating System
GenesisCS Component Concentrating System
June 2024
Instruction for Use
NOTE: DEVICE IS FOR SINGLE USE ONLY. Discard the entire disposable systemafter one use, using an acceptable disposal method for products potentially contaminatedwith blood.

INSTRUCTIONS FOR USE FOR 60mL SYSTEMPREPARATION PROTOCOL:
22.

DESCRIPTION
1. The PurePRP® Supraphysiologic Concentrating System is manufactured by EmCyte
Corporation. The kit prepares platelet rich plasma from a small sample of blood at
the point of care. The system contains syringes, needles and the concentrating device
accessories.

23.

MATERIALS
2. The materials used are syringes, needles, tubing, connectors, and concentrating
devices. The materials consist of medical grade polymers, elastomers and stainlesssteel that are suitable for use in medical devices. All components in this system arepackaged, labeled and sterilized as indicated by the manufacturer’s labeling. Allcomponents in this system are latex-free.
INDICATIONS FOR USE STATEMENTS
3. The PurePRP® Supraphysiologic Concentrating System is designed to be used forthe 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 is mixed with autograft andallograft bone prior to application to an orthopedic site to improve bone graft
handling characteristics.
4. The safety and effectiveness of this device for in vivo indications for use, such asbone healing and hemostasis, have not been established.
5. The PRP prepared by this device has not been evaluated for any clinical indications.
6. The PRP prepared by this device is NOT indicated for delivery to the patient’s
circulatory system.

NOTE: Use standard sterile aseptic technique throughout the following
procedure. Always swab needle-less ports with alcohol before and after
accessing.
WHOLE BLOOD DRAW: Attach the sterile filter needle onto the sterile
60mL syringe. Draw 8mL of Citrate Anticoagulant into the 60mL syringe.
Remove the filter needle from the syringe. Attach the butterfly needle onto
60mL syringe and prime the needle with the anticoagulant. Slowly draw
52mL of whole blood from the patient filling the syringe to 60mL. Gently, but
thoroughly mix the blood and anticoagulant upon collection to prevent
coagulation.

CONCENTRATING PROTOCOL:
24. LOAD: IMPORTANT: Attach sterile non-vented clear cap to the bottom
port of the device. STERILE CLEAR CAP MUST BE ATTACHED TO
THE BOTTOM PORT BEFORE CENTRIFUGATION.
WITH TOP VENT OPEN, slowly add the anticoagulated whole blood
through the top port of the Concentrating Device. THEN CLOSE VENT.
25. BALANCE: Make sure the counterbalance device contains the same amountof volume as the Concentrating Device. Then place them directly opposite toeach other in the centrifuge rotor buckets. Close the lid.
26. FIRST SPIN:a.
Sapphire Series Centrifuge: PUREPRP 60 SPIN 1.
b.
Platinum Series Centrifuge: PUREPRP SP SPIN 1.
c.
Executive Series Centrifuge: 2.0 minutes and 4400 RPM.
d.
Press the start button. Once the centrifuge stops, remove the Device.
27. FIRST EXTRACTION & TRANSFER: Attach the sterile 60mL syringe to the
top port.
a.
LP-Protocol A - Aspirate the platelet plasma suspension

USER POPULATIONb.

7. The intended user population is medical professionals who are licensed or certified
in clinical practice. The operational context of the device requires users to be trainedon aseptic technique and understand blood components. The surgeon is to bethoroughly familiar with the equipment and the surgical procedure prior to using thisdevice.

c.

28.

SECOND SPIN: Place Concentrating Device back into the centrifuge rotor
bucket directly opposite the counterbalance device. Close the lid.
a.
Sapphire Series Centrifuge: PUREPRP 60 SPIN 2.
b.
Platinum Series Centrifuge: PUREPRP SP SPIN 2.
c.
Executive Series Centrifuge:4.0 minutes and 4400 RPM.
d.
Press the start button. Once the centrifuge stops, remove the29.

SECOND EXTRACTION: Remove the clear cap from the bottom port.
Using the 60mL syringe, aspirate plasma from the bottom port leaving 7mL in
the device.
RESUSPEND THE PRP: Gently swirl the Concentrating Device to re-suspend
the platelet concentrate into the plasma.
EXTRACT PRP: Attach a sterile 12mL syringe to the bottom port and tilt
to immerse the aspirating pipe, then aspirate the platelet rich plasma
through the open port of the aspirating pipe. Remove sterile syringe andapply a sterile cap.

DEVICE USE ENVIRONMENT
8. The device is intended to be used in in a health care setting such as a surgery room,
clinic or outpatient care center.
WARNING AND PRECAUTIONS
9. Use proper safety precautions to guard against needle sticks.
10. Follow manufacturer instructions when using centrifuge. Use only EmCyte
provided general purpose centrifuge. Outcomes using centrifuges from othermanufacturers are unknown.
11. Do not use sterile components of this system if package is opened or damaged.
12. Single use device. Do not reuse. Do not attempt to clean or re-sterilize thisproduct.
13. Do not use after expiration date.
14. Use prepared PRP within 4 hours after drawing blood according to current
AABB guidelines.

(PPS) into the 60mL syringe. (Optionally, aspirate additional
0.5mL of RBC for optimal platelet recovery.)
LR-Protocol B - Aspirate the platelet plasma suspension(PPS) and approximately 1mL of RBC into the 60mL syringe.
Inject the platelet plasma suspension through bottom port ofDevice. Then SNUGGLY PLACE STERILE CLEARCAP ON THE BOTTOM PORT!!!

Device.

30.
31.

POSSIBLE RISKS
15.

16.

The patient is to be made aware of the general risks associated with whole blood
aspiration. These risks include, but are not limited to: hemorrhage, seroma
formation, infection, and/or persistent pain at the site of aspiration.
Reuse may be a potential biohazard

POSSIBLE ADVERSE EFFECTS
17.
18.
19.
20.

Damage to blood vessels, hematoma, delayed wound healing and/or infection isassociated with blood draw, and/or surgical procedure.
Temporary or permanent nerve damage that may result in pain or numbness is
associated with blood draw, and/or surgica procedure.
Early or late postoperative infection is associated with surgical procedure.
Pain associated with site of whole blood harvest.

STERILITY
21.

The PurePRP® SupraPhysiologic Concentrating System kits are sterilized by
ETO exposure. Do not use any component from an opened or damaged
package. Do not resterilize. Discard if kit packaging is damaged or open.

EmCyte Corporation | 4331 Veronica S. Shoemaker Blvd., Suite 4 Fort Myers, FL 33916 www.emcyte.com | PL-42-82, Rev. 9

INSTRUCTIONS FOR USE FOR 120mL SYSTEM
INSTRUCTIONS FOR USE FOR 30mL SYSTEMPREPARATION PROTOCOL:PREPARATION PROTOCOL:

32.
33.

NOTE: Use standard sterile aseptic technique throughout the following
procedure. Always swab needle-less ports with alcohol before and after
accessing.
WHOLE BLOOD DRAW: Attach the sterile filter needle onto the sterile
30mL syringe. Draw 3mL of Citrate Anticoagulant into the 30mL syringe.
Remove the filter needle from the syringe. Attach the butterfly needle onto
60mL syringe and prime the needle with the anticoagulant. Slowly draw
27mL of whole blood from the patient filling the syringe to 30mL. Gently, but
thoroughly mix the blood and anticoagulant upon collection to prevent
coagulation.

CONCENTRATING PROTOCOL:
44. LOAD: IMPORTANT: Attach sterile non-vented clear cap to the bottom
port of the device. STERILE CLEAR CAP MUST BE ATTACHEDTO THE BOTTOM PORT BEFORE CENTRIFUGATION.
WITH TOP VENT OPEN, slowly add the anticoagulated whole blood
through the top port of the Concentrating Device. THEN CLOSE VENT.
45. BALANCE: Make sure the counterbalance device contains the same amountof volume as the Concentrating Device. Then place them directly opposite toeach other in the centrifuge rotor buckets. Close the lid.
46. FIRST SPIN:a.
Sapphire Series Centrifuge: PUREPRP 30 SPIN 1.
b.
Platinum Series Centrifuge: PUREPRP SP SPIN 1.
c.
Executive Series Centrifuge: 1.0 minutes and 4400 RPM.
d.
Press the start button. Once the centrifuge stops, remove

the Device.
47.

FIRST EXTRACTION & TRANSFER: Attach the sterile 30mL syringe to the
top port.
a.
LP-Protocol A - Aspirate the platelet plasma suspension

b.

c.

42.
43.

CONCENTRATING PROTOCOL:
52. LOAD: IMPORTANT: Attach sterile non-vented clear cap to the bottom port
of EACH device. STERILE CLEAR CAP MUST BE ATTACHED TO THE
BOTTOM PORT BEFORE CENTRIFUGATION. WITH WHITEVENT OPEN, slowly inject the anticoagulated whole blood through the top port
of EACH Concentrating Device. THEN CLOSE WHITE VENT ON EACH
DEVICE.
53. BALANCE: Make sure EACH device contains the same amount of volume. Thenplace them directly opposite to each other in the centrifuge rotor buckets. Close thelid.
54. FIRST SPIN:a.
Sapphire Series Centrifuge: PUREPRP 60 SPIN 1.
b.
Platinum Series Centrifuge: PUREPRP SP SPIN 1.
c.
Executive Series Centrifuge: 2.0 minutes and 4400 RPM.
d.
Press the start button. Once the centrifuge stops, remove theDevice.
55.

(PPS) into the 30mL syringe. (Optionally, aspirate
additional 0.5mL of RBC for optimal platelet recovery.)
LR-Protocol B - Aspirate the platelet plasma suspension(PPS) and approximately 1mL of RBC into the 30mL
syringe.
Inject the platelet plasma suspension through bottom portof Device. Then SNUGGLY PLACE STERILE
CLEAR CAP ON THE BOTTOM PORT!!!

48.

SECOND SPIN: Place Concentrating Device back into the centrifuge rotor
bucket directly opposite the counterbalance device. Close the lid.
a.
Sapphire Series Centrifuge: PUREPRP 30 SPIN 2.
b.
Platinum Series Centrifuge: PUREPRP SP SPIN 2.
c.
Executive Series Centrifuge: 3.0 minutes and 4400 RPM.
d.
Press the start button. Once the centrifuge stops, remove

49.

SECOND EXTRACTION: Remove the clear cap from the bottom port.
Using the 60mL syringe, aspirate plasma from the bottom port leaving 7mL in
the device.
RESUSPEND THE PRP: Gently swirl the Concentrating Device to re-suspend
the platelet concentrate into the plasma.
EXTRACT PRP: Attach a sterile 12mL syringe to the bottom port and tilt
to immerse the aspirating pipe, then aspirate the platelet rich plasma
through the open port of the aspirating pipe. Remove sterile syringe andapply a sterile cap.

51.

FIRST EXTRACTION & TRANSFER: Attach the sterile 60mL syringe to the top
port of EACH Device.
a.
LP-Protocol A - Aspirate the platelet plasma suspension (PPS)b.
c.

into the 60mL syringe. (Optionally, aspirate additional 0.5mL of
RBC for optimal platelet recovery.)
LR-Protocol B - Aspirate the platelet plasma suspension (PPS)
and approximately 1mL of RBC into the 60mL syringe.
Inject the platelet plasma suspension through bottom port of
EACH Device. Then SNUGGLY PLACE STERILE CLEARCAP ON THE BOTTOM PORT OF EACH DEVICE!!!

56.

SECOND SPIN: Place Concentrating Devices back into the centrifuge rotor bucket
directly opposite the counterbalance device. Close the lid.
a.
Sapphire Series Centrifuge: PUREPRP 60 SPIN 2.
b.
Platinum Series Centrifuge: PUREPRP SP SPIN 2.
c.
Executive Series Centrifuge:4.0 minutes and 4400 RPM.
d.
Press the start button. Once the centrifuge stops, remove EACH

57.

SECOND EXTRACTION: Remove the clear cap from the bottom port of EACH
device. Using a 60mL syringe, aspirate plasma from the bottom port, leaving 7mL
in EACH device.
RESUSPEND THE PRP: Gently swirl the Concentrating Device to re-suspend theplatelet concentrate into the plasma.
EXTRACT PRP: Attach a sterile 12mL syringe to the bottom port of EACH
DEVICE and tilt to immerse the aspirating pipe, then aspirate the platelet richplasma through the open port of the aspirating pipe. Remove sterile syringe andapply a sterile cap.

Device.

the Device.

50.

NOTE: Use standard sterile aseptic technique throughout the following
procedure. Always swab needle-less ports with alcohol before and after
accessing.
WHOLE BLOOD DRAW: Attach the sterile filter needle onto two sterile 60mL
syringes. Draw 8mL of Citrate Anticoagulant into each 60mL syringe. Remove
the filter needle from the syringes. Attach the butterfly needle onto 60mL syringe
and prime the needle with the anticoagulant. Slowly draw 52mL of whole blood
per syringe, from the patient filling each syringe to 60mL. Gently, but thoroughly
mix the blood and anticoagulant upon collection to prevent coagulation.

58.
59.

Caution: Federal Law (USA) restricts this device to sale by or on the order of aphysician.

Medical Device

Non-pyrogenic

EmCyte Corporation | 4331 Veronica S. Shoemaker Blvd., Suite 4 Fort Myers, FL 33916 www.emcyte.com | PL-42-82, Rev. 9

GS60-SP: IFU ILLUSTRATIONNOTICES: ALWAYS SWAB SELF-SEALING PORT WITH STERILE ALCOHOL PRIOR TO ACCESSING WITH A STERILE SYRINGE
PREPARATION PROTOCOLSTEP 1:

STEP 2:ATTACH
CLEAR CAP

Using the filtered needle, draw 8mL of Sodium Citrate Anticoagulant into 60mL
Syringe. Then collect 52mL whole blood filling syringe to 60mL.

Attach clear non vented cap to the bottom port.

CONCENTRATING PROTOCOLSTEP 3:

STEP 4:

VENT LID
CLOSED

STEP 5:

Sapphire Series Centrifuge:
PUREPRP 60 SPIN 1

VENT LID
OPEN

Close VENT LID and counterbalance
device with equal volume.

With VENT LID OPEN
Inject anticoagulated whole blood
through the top needle-less port.

Platinum Series Centrifuge:
PUREPRP SP SPIN 1

Executive Series Centrifuge
Set to 2 minutes and 4400
Place in the centrifuge rotor at opposite
ends.

STEP 6: LP-PROTOCOL A

STEP 6: LR-PROTOCOL B
Optional
0.5mL
RBC
ButtonLP-PROTOCOL A: Connect the 60mL syringe to the top port and aspirate theplatelet plasma suspension (PPS) into the 60mL syringe. (Optionally, aspirate
additional 0.5mL of RBC for optimal platelet recovery).

1mL
RBC

LR-PROTOCOL B: Connect the 60mL syringe to the top port and aspirate theplatelet plasma suspension (PPS) into the 60mL syringe. Aspirate additional 1mLof RBC.

EmCyte Corporation | 4331 Veronica S. Shoemaker Blvd., Suite 4 Fort Myers, FL 33916 www.emcyte.com | PL-42-82, Rev. 9

STEP 7:

STEP 8:STEP 9:STEP 10:

Leave
7mL

Place back in centrifuge
rotor.
Process at:

Sapphire Series Centrifuge:
PUREPRP 60 SPIN 2
Re-Capwith clear
cap

Plateletbuffycoat

Platinum Series Centrifuge:
PUREPRP SP SPIN 2
Executive Series Centrifuge
4 minutes and 4400
After centrifugation, the platelet
buffycoat will be separated at the bottomof the device.

Inject PPS solution into the device
through the bottom port. Then recap
with sterile clear cap.

STEP 11:

Connect the syringe to the bottom
needle-less port and aspirate plasma,leaving 7mL in the device.

STEP 12:

Gently swirl to resuspend the platelet
buffycoat into the plasma.

Connect the 12mL syringe to the bottom needle-less port and tilt to aspirate the PRP
through the open port of the Aspirating Pipe.

STEP 13:7mL PRP

EmCyte Corporation | 4331 Veronica S. Shoemaker Blvd., Suite 4 Fort Myers, FL 33916 www.emcyte.com | PL-42-82, Rev. 9

GS30-SP: IFU ILLUSTRATIONNOTICES: ALWAYS SWAB SELF-SEALING PORT WITH STERILE ALCOHOL PRIOR TO ACCESSING WITH A STERILE SYRINGE
PREPARATION PROTOCOLSTEP 1:

STEP 2:ATTACHCLEAR
NONVENTEDCAP

Attach clear non vented cap to the bottom port.
Using the filtered needle, draw 3mL of Sodium Citrate Anticoagulant into 30mL
syringe. Then collect 27mL whole blood filling syringe to 30mL.

CONCENTRATING PROTOCOLSTEP 3:

STEP 4:

VENT LID
CLOSED

STEP 5:

Sapphire Series Centrifuge:
PUREPRP 30 SPIN 1

VENT LID
OPEN

Platinum Series Centrifuge:
PUREPRP SP SPIN 1
Close VENT LID and counterbalance
device with equal volume

Executive Series Centrifuge
Set to 1 minutes and 4400

With VENT LID OPEN
Inject anticoagulated whole blood
through the top needle-less port.

Place in the centrifuge rotor at opposite
ends.

STEP 6: LP-PROTOCOL A

STEP 6: LR-PROTOCOL B
Optional
0.5mL
RBC
ButtonLP-PROTOCOL A: Connect the 30mL syringe to the top port and aspirate theplatelet plasma suspension (PPS) into the 30mL syringe. Aspirate additional 0.5mL
of RBC for optimal platelet recovery.

1mL
RBC

LR-PROTOCOL B: Connect the 30mL syringe to the top port and aspirate theplatelet plasma suspension (PPS) into the 30mL syringe. Aspirate additional 1mL of
RBC.

EmCyte Corporation | 4331 Veronica S. Shoemaker Blvd., Suite 4 Fort Myers, FL 33916 www.emcyte.com | PL-42-82, Rev. 9

STEP 7:

STEP 8:STEP 9:STEP 10:

Place back in centrifuge rotor.
Process at:

Sapphire Series Centrifuge:
PUREPRP 30 SPIN 2
Re-Capwithclear cap

Leave
3-4mL

Plateletbuffycoat

Platinum Series Centrifuge:
PUREPRP SP SPIN 2
Executive Series Centrifuge
3 minutes and 4400
After centrifugation, the platelet
buffycoat will be separated at the bottomof the device.

Inject PPS solution into the device
through the bottom port. Then recap
with sterile clear cap.
Connect the syringe to the bottom
needle-less port and aspirate plasma,leaving 3-4mL in the device.

STEP 11:

STEP 12:

STEP 13:

Gently swirl to resuspend the platelet
buffycoat into the plasma.
3-4mL PRP
Connect the 12mL syringe to the bottom needle-less port and tilt to aspirate the PRP
from the open port of the Aspirating Pipe.

EmCyte Corporation | 4331 Veronica S. Shoemaker Blvd., Fort Myers, FL 33916 www.emcyte.com | PL-42-82, Rev. 9

GS120-SP: IFU ILLUSTRATIONNOTICES: ALWAYS SWAB SELF-SEALING PORT WITH STERILE ALCOHOL PRIOR TO ACCESSING WITH A STERILE SYRINGE
PREPARATION PROTOCOLSTEP 1:

STEP 2:ATTACHCLEAR
NONVENTEDCAP

Using the filtered needle, draw 8mL of Sodium Citrate Anticoagulant into two(2) 60mL Syringes. Then collect 52mL whole blood filling EACH syringe to
60mL.

Attach clear non vented cap to the bottom port of EACH device.

CONCENTRATING PROTOCOLSTEP 3:

STEP 4:

VENT LID
CLOSED

STEP 5:

Sapphire Series Centrifuge:
PUREPRP 60 SPIN 1

VENT LID
OPEN

Platinum Series Centrifuge:
PUREPRP SP SPIN 1
Close VENT LID of EACH device

Executive Series Centrifuge
Set to 2 minutes and 4400

With VENT LID OPEN
Inject 60mL anticoagulated whole
blood through the top needle-less port
of EACH device.
Place devices in the centrifuge rotor at
opposite ends.

STEP 6: LP-PROTOCOL A

STEP 6: LR-PROTOCOL B
Optional
0.5mL
RBC
ButtonLP-PROTOCOL A: FOR EACH DEVICE, connect the 60mL syringe to the top
port and aspirate the platelet plasma suspension (PPS) into the 60mL syringe.
(Optionally, aspirate additional 0.5mL of RBC for optimal platelet recovery).

1mL
RBC

LR-PROTOCOL B: FOR EACH DEVICE, connect the 60mL syringe to the top
port and aspirate the platelet plasma suspension (PPS) into the 60mL syringe.
Aspirate additional 1mL of RBC for optimal platelet recovery).

EmCyte Corporation | 4331 Veronica S. Shoemaker Blvd., Suite 4 Fort Myers, FL 33916 www.emcyte.com | PL-42-82, Rev. 9

STEP 7:

STEP 8:STEP 9:STEP 10:

Place back in centrifuge rotor.
Process at:

Sapphire Series Centrifuge:
PUREPRP 60 SPIN 2
Re-Capwithclear cap

PlateletbuffycoatLeave
7mL inEACH
DevicePlatinum Series Centrifuge:
PUREPRP SP SPIN 2
Executive Series Centrifuge
4 minutes and 4400
After centrifugation, the platelet
buffycoat will be separated at the bottom
of EACH device.

FOR EACH DEVICE. Inject PPS
solution into the device through thebottom port. Then recap with sterile
clear cap.

Connect the syringe to the bottom
needle-less port OF EACH DEVICE andaspirate plasma, leaving 7mL in thedevice.

STEP 11:

STEP 12:

Gently swirl EACH DEVICE toresuspend the platelet buffycoat into theplasma.

Connect the 12mL syringe to the bottom needle-less port OF EACH DEVICE and tilt
to aspirate the PRP from the open port of the Aspirating Pipe.

STEP 13:14mL PRPEmCyte Corporation | 4331 Veronica S. Shoemaker Blvd., Suite 4 Fort Myers, FL 33916 www.emcyte.com | PL-42-82, Rev. 9