AbsoluteBMC™
Bone Marrow Concentrating System
GenesisCS Component Concentrating System
Date: May 2024
Instruction for Use
ATTENTION OPERATING SURGEONNOTE: DEVICE IS FOR SINGLE USE ONLY. Discard the entire disposable
system after one use, using an acceptable disposal method for products
potentially contaminated with blood.
DESCRIPTION
The AbsoluteBMC™ GenesisCS Component Concentrating System ismanufactured by EmCyte Corporation. The kit prepares platelet poor
plasma and platelet concentrate from a small sample of blood and a cellconcentrate from bone marrow at the point of care. The system containssyringes, a bone marrow needle accessory, and the concentrating device
accessories.

1.

MATERIALS
2.

The materials used are syringes, needles, tubing, connectors, andconcentrating devices. The materials consist of medical grade polymers,
elastomers and stainless steel that are suitable for use in medical devices.
All components in this system are packaged, labeled and sterilized asindicated by the manufacturer’s labeling. All components in this system
are latex-free.

INDICATIONS FOR USE STATEMENTS
3.

The GenesisCS Component Concentrating System is intended to be used
in a clinical laboratory or intraoperatively at the point of care for the safeand rapid preparation of platelet poor plasma and platelet concentratefrom a small sample of blood and for a preparation of a cell concentratefrom bone marrow. The safety and effectiveness of this device for in vivo
indications for use has not been established.
The safety and effectiveness of this device for in vivo indications for use,such as bone healing and hemostasis, have not been established.
The PRP and BMC prepared by this device has not been evaluated for any
clinical indications.
The PRP and BMC prepared by this device is NOT indicated for delivery
to the patient’s circulatory system.

4.
5.
6.

USER POPULATION
7.
8.
9.
10.
11.

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 trained on aseptic technique and understand blood
components. The surgeon is to be thoroughly familiar with theequipment and the surgical procedure prior to using this device.

21. The patient is to be made aware of the general risks associated with bonemarrow aspiration. These risks include, but are not limited to:hemorrhage, seroma formation, infection, and/or persistent pain at the siteof aspiration.
22. Reuse may be a potential biohazard
POSSIBLE ADVERSE EFFECTS
23. Damage to blood vessels, hematoma, delayed wound healing and/or
infection is associated with blood draw, bone marrow harvest and/or
surgical procedure.
24. Temporary or permanent nerve damage that may result in pain or
numbness is associated with blood draw, and/or surgical procedure.
25. Early or late postoperative infection is associated with surgical procedure.
26. Pain associated with site of bone marrow harvest.
STERILITY
27. The AbsoluteBMC™ GenesisCS Component 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.
INSTRUCTIONS FOR USE FOR 60mL SYSTEMPREPARATION PROTOCOLNOTE: Use standard sterile aseptic technique throughout the following
procedure. Always swab needle-less ports with alcohol before and afteraccessing.
28. BONE MARROW ASPIRATE DRAW:
Attach the sterile filter needle onto the 60mL VACLOK syringe. Draw
15mL of Heparin Anticoagulant (1000 units/mL) into the 60mL syringe.
Remove the filter needle from the syringe. Then prime the bone marrowaspirating cannula by injecting 5mL of heparin through it. Attach theheparin syringe to the OUT port of the bone marow filter. Inject Heparin
filling the filter to prime and then aspirate the heparin back into thesyringe. Then discard heparin leaving 5mL in the VACLOK syringe.
Slowly draw 55mL of bone marrow aspirate (BMA) from the patient,filling the syringe to 60mL. Follow the bone marrow needle
manufacturer’s package insert to obtain bone marrow aspirate. Gently, butthoroughly mix the BMA and heparin upon collection to prevent
coagulation.
29. FILTER: Connect a 60mL syringe to the OUT port of the bone marrowfilter. Connect the VACLOK bone marrow syringe to the IN port of thefilter. Inject the BMA through the filter into the 60mL syringe. Oncecompleted, clear the remaining bone marrow in the filter by aspirating it
into the 60mL syringe.
CONCENTRATING PROTOCOLDEVICE USE ENVIRONMENT
12. The device is intended to be used in in a health care setting such as asurgery room, clinic or outpatient care center.
WARNING AND PRECAUTIONS
13. Use proper safety precautions to guard against needle sticks.
14. Follow manufacturer instructions when using centrifuge. Use only
EmCyte provided general purpose centrifuge. Outcomes using
centrifuges from other manufacturers are unknown.
15. When using the bone marrow aspiration needle, follow manufacturer’s
instruction for use.
16. Do not use sterile components of this system if package is opened ordamaged.
17. Single use device. Do not reuse. Do not attempt to clean or re-sterilize thisproduct.
18. Do not use after expiration date.
19. Use prepared BMC, PPP or PRP within 4 hours after drawing blood orbone marrow aspirate according to current AABB guidelines.
20. BMC prepared from bone marrow may contain higher levels of plasma
free hemoglobin than PRP prepared from whole blood.

30. LOAD: Remove and discard the red vented cap from the needle-less portof the Concentrating Device. Slowly add the filtered and anticoagulated
BMA through the port of the Concentrating Device.
31. BALANCE: Make sure the counterbalance device contains the sameamount of volume as the Concentrating Device. Then place them directly
opposite to each other in the centrifuge rotor buckets.
32. CENTRIFUGATION:a.
Sapphire Series Centrifuge: Close the lid and set to
ABSOLUTEPRP/BMC.
b. Platinum Series Centrifuge: Close the lid and set to
ABSOLUTEPRP/BMC.
c.
Executive Series Centrifuge: Close the lid and set to 10
minutes and 4.4 x 1000 RPM (4400 RPM).
d. Press the start button. Once the centrifuge stops, remove theConcentrating Device.
33. BMC EXTRACTION: Attach the sterile 60mL syringe to the needleless port and aspirate the plasma until the bone marrow RBC interface
reaches the 7mL volume marker, then stop aspirating. Then attach the12mL syringe and aspirate 7mL of BMC. Remove sterile syringe andapply a sterile cap.

POSSIBLE RISKSEmCyte Corporation
4331 Veronica S. Shoemaker Blvd., Fort Myers, FL 33916 USA www.emcyte.com
PL-42-85, Rev 4

INSTRUCTIONS FOR USE FOR 120mL SYSTEM
INSTRUCTIONS FOR USE FOR 30mL SYSTEMPREPARATION PROTOCOLPREPARATION PROTOCOLNOTE: Use standard sterile aseptic technique throughout the following
procedure. Always swab needle-less ports with alcohol before and afteraccessing.
34. BONE MARROW ASPIRATE DRAW:
Attach the sterile filter needle onto the 30mL VACLOK syringe. Draw
15mL of Heparin Anticoagulant (1000 units/mL) into the 30mL syringe.
Remove the filter needle from the syringe. Then prime the bone marrowaspirating cannula by injecting 5mL of heparin through it. Attach theheparin syringe to the OUT port of the bone marow filter. Inject Heparin
filling the filter to prime and then aspirate the heparin back into thesyringe. Then discard heparin leaving 3mL in the VACLOK syringe.
Slowly draw 27mL of bone marrow aspirate (BMA) from the patient,filling the syringe to 30mL. Follow the bone marrow needle
manufacturer’s package insert to obtain bone marrow aspirate. Gently, but
thoroughly mix the BMA and heparin upon collection to prevent
coagulation.
35. FILTER: Connect a 30mL syringe to the OUT port of the bone marrowfilter. Connect the VACLOK bone marrow syringe to the IN port of thefilter. Inject the BMA through the filter into the 30mL syringe. Oncecompleted, clear the remaining bone marrow in the filter by aspirating it
into the 30mL syringe.
CONCENTRATING PROTOCOL
36. LOAD: Remove and discard the red vented cap from the needle-less portof the Concentrating Device. Slowly add the filtered and anticoagulated
BMA through the port of the Concentrating Device.
37. BALANCE: Make sure the counterbalance device contains the sameamount of volume as the Concentrating Device. Then place them directly
opposite to each other in the centrifuge rotor buckets.
38. CENTRIFUGATION:a.
Sapphire Series Centrifuge: Close the lid and set to
ABSOLUTEPRP/BMC.
b. Platinum Series Centrifuge: Close the lid and set to
ABSOLUTEPRP/BMC.
c.
Executive Series Centrifuge: Close the lid and set to 10
minutes and 4.4 x 1000 RPM (4400 RPM).
d. Press the start button. Once the centrifuge stops, remove theConcentrating Device.
39. BMC EXTRACTION: Attach the sterile 30mL syringe to the needleless port and aspirate the plasma until the bone marrow RBC interface
reaches the 3mL volume marker, then stop aspirating. Then attach the12mL syringe and aspirate 3-4mL of BMC. Remove sterile syringe andapply a sterile cap.

NOTE: Use standard sterile aseptic technique throughout the following
procedure. Always swab needle-less ports with alcohol before and afteraccessing.
40. BONE MARROW ASPIRATE DRAW:
Attach the sterile filter needles onto the 60mL VACLOK syringes. Draw
15mL of Heparin Anticoagulant (1000 units/mL) into each of the 60mL
syringes. Remove the filter needle from the syringe. Then prime the bonemarrow aspirating cannula by injecting 5mL of heparin through it. Attach
the heparin syringe to the OUT port of the bone marow filter. Inject 5mL
into the filter to prime and then aspirate the heparin back into the syringe.
Then discard heparin leaving 5mL in the VACLOK syringe. Then attach
the sterile filter needle onto the second VACLOK syringe and draw 5mLof Heparin Anticoagulant (1000 units/mL) into it. For each VACLOK
syringe, slowly draw 55mL of bone marrow aspirate (BMA) from thepatient, filling each syringe to 60mL. Follow the bone marrow needle
manufacturer’s package insert to obtain bone marrow aspirate. Gently, but
thoroughly mix the BMA and heparin upon collection to prevent
coagulation.
41. FILTER: For each VACLOK syringe do the following steps. Connect a60mL syringe to the OUT port of the bone marrow filter. Connect theVACLOK bone marrow syringe to the IN port of the filter. Inject theBMA through the filter into the 60mL syringe. Once completed, clear theremaining bone marrow in the filter by aspirating it into the 60mLsyringe.
CONCENTRATING PROTOCOL
42. LOAD: For each Concentrating Device do the following steps. Removeand discard the red vented cap from the needle-less port of theConcentrating Device. Slowly add the filtered and anticoagulated BMA
through the port of the Concentrating Device.
43. BALANCE: Make sure each Concentrating device contains the sameamount of volume. Then place them directly opposite to each other in thecentrifuge rotor buckets.
44. CENTRIFUGATION:a.
Sapphire Series Centrifuge: Close the lid and set toABSOLUTEPRP/BMC.
b. Platinum Series Centrifuge: Close the lid and set to
ABSOLUTEPRP/BMC.
c.
Executive Series Centrifuge: Close the lid and set to 10
minutes and 4.4 x 1000 RPM (4400 RPM).
d. Press the start button. Once the centrifuge stops, remove theConcentrating Device.
45. BMC EXTRACTION: For each device, attach the sterile 60mL syringe
to the needle-less port and aspirate the plasma until the bone marrow
RBC interface reaches the 7mL volume marker, then stop aspirating.
Then attach the 12mL syringe and aspirate 7mL of BMC. Collect a totalof 14mL of BMC. Remove sterile syringe and apply a sterile cap.
Caution: Federal Law (USA) restricts this device to sale by or on the order of aphysician.

Non-pyrogenicEmCyte Corporation
4331 Veronica S. Shoemaker Blvd., Fort Myers, FL 33916 USA www.emcyte.com
PL-42-85, Rev 4

Medical Device

GSBMA-30: IFU ILLUSTRATIONNOTICES: PLEASE DISCARD RED VENTED CAP FROM CONCENTRATING DEVICE BEFORE USE.
ALWAYS SWAB SELF-SEALING PORT WITH STERILE ALCOHOL PRIOR TO ACCESSING WITH A STERILE SYRINGE.
PREPARATION PROTOCOLSTEP 1:

STEP 2:

Attach the sterile filter needle onto
the VACLOK 30mL syringe. Thendraw 15mL of Heparin
Anticoagulant

STEP 3:

Then prime the bone marrowaspirating cannula by injecting 5mL ofheparin through it

STEP 4:

Then discard the residual heparinleaving 3mL in the VACLOK
syringe

Attach to the OUT port of the bonemarrow filter. Fill to prime andthen aspirate back into the syringe(1000 units/mL)

CONCENTRATING PROTOCOLSTEP 1:

STEP 2:

STEP 3:

Counterbalance with the same
volume as the Concentrating
Device.

FilterSlowly draw 27mL of bone marrowaspirate, filling the syringe to30mL. Mix the BMA and heparin
upon collection to prevent
coagulation.

StartSTEP 4:

EndConnect a 30mL syringe to the OUT
port of the bone marrow filter.
Connect the VACLOK bone marrowsyringe to the IN port of the filter.
Inject the BMA through the filter intothe 30mL syringe.

Inject anticoagulated & filtered
BMA into the Concentrating
DeviceThen place them directly opposite
to each other in the centrifuge rotor
buckets.

EmCyte Corporation
4331 Veronica S. Shoemaker Blvd., Fort Myers, FL 33916 USA www.emcyte.com
PL-42-85, Rev 4STEP 5:

STEP 6:

Sapphire Series
Centrifuge:
AbsolutePRP/BMC
Platinum Series
Centrifuge:
AbsolutePRP/BMC
Executive Series
Centrifuge:
10 minutes
4400 RPM

RBC interface reaches
3mL volume marker

Attach the 30mL syringe and aspirate the plasma until the bone marrow RBC interface reaches the 3mL volume
marker, then stop aspirating

STEP 7:

3-4mL BMC
(Plasma & BMC buffycoat)

Attach the 12mL syringe and aspirate 3-4mL BMC(Rotate the syringe to re-suspend the BMC buffycoat into the plasma)

EmCyte Corporation
4331 Veronica S. Shoemaker Blvd., Fort Myers, FL 33916 USA www.emcyte.com
PL-42-85, Rev 4GSBMA-60: IFU ILLUSTRATIONNOTICES: PLEASE DISCARD RED VENTED CAP FROM CONCENTRATING DEVICE BEFORE USE.
ALWAYS SWAB SELF-SEALING PORT WITH STERILE ALCOHOL PRIOR TO ACCESSING WITH A STERILE SYRINGE.
PREPARATION PROTOCOL:STEP 1:

STEP 2:

Attach the sterile filter needle onto
the VACLOK 60mL syringe.
Then draw 15mL of Heparin
Anticoagulant

STEP 3:

Then prime the bone marrowaspirating cannula by injecting 5mLof heparin through itAttach to the OUT port of thebone marrow filter. Fill to prime
and then aspirate back into thesyringe

STEP 4:

Then discard the residual heparinleaving 5mL in the VACLOK
syringe(1000 units/mL)

CONCENTRATING PROTOCOLSTEP 1:

STEP 2:

STEP 3:

STEP 4:FilterCounterbalance with the same
volume as the Concentrating
Device.

Slowly draw 55mL of bonemarrow aspirate, filling the syringe
to 60mL. Mix the BMA andheparin upon collection to prevent
coagulation.

Inject anticoagulated & filtered
BMA into the Concentrating
DeviceStartEnd

Connect a 60mL syringe to the OUT
port of the bone marrow filter.
Connect the VACLOK bone marrowsyringe to the IN port of the filter.
Inject the BMA through the filter
into the 60mL syringe.

Then place them directly opposite
to each other in the centrifuge rotor
buckets.

EmCyte Corporation
4331 Veronica S. Shoemaker Blvd., Fort Myers, FL 33916 USA www.emcyte.com
PL-42-85, Rev 4

STEP 5:

STEP 6:

Sapphire Series
Centrifuge:
AbsolutePRP/BMC
Platinum Series
Centrifuge:
AbsolutePRP/BMC
BMC RBC interface reaches
7mL volume marker

Executive SeriesCentrifuge:
10 minutes
4400 RPM

Attach the 60mL syringe and aspirate the plasma until the bone marrow RBC interface reaches the 7mL volumemarker, then stop aspirating

STEP 7:7mL BMC(Plasma & BMC buffycoat )Attach the 12mL syringe and aspirate 7mL BMC(Rotate the syringe to re-suspend the BMC buffycoat into the plasma)

EmCyte Corporation
4331 Veronica S. Shoemaker Blvd., Fort Myers, FL 33916 USA www.emcyte.com
PL-42-85, Rev 4

GSBMA-120: IFU ILLUSTRATIONNOTICES: PLEASE DISCARD RED VENTED CAP FROM CONCENTRATING DEVICE BEFORE USE.
ALWAYS SWAB SELF-SEALING PORT WITH STERILE ALCOHOL PRIOR TO ACCESSING WITH A STERILE SYRINGE.
PREPARATION PROTOCOL:STEP 1:

STEP 2:

STEP 3:

STEP 4:

Then discard the residual heparinleaving 5mL in each VACLOKsyringe
Attach the sterile filter needle onto
the VACLOK 60mL syringe. Thendraw 15mL of Heparin
Anticoagulant

Then prime the bone marrowaspirating cannula by injecting 5mLof heparin through it

Attach to the OUT port of thebone marrow filter. Fill to prime
and then aspirate back into thesyringe

Step 2:

Step 3:(1000 units/mL)

CONCENTRATING PROTOCOL
Step 1:

Step 4:FilterCounterbalance with the same
volume in each ConcentratingDevice.

Inject 60mL of anticoagulated &filtered BMA into each
Concentrating Device
Slowly draw 55mL of bone marrowaspirate, filling each syringe to60mL. Mix the BMA and heparin
upon collection to prevent
coagulation.

StartEndFor each BMA syringe filter theBMA in the direction indicated on thefilter.

Then place them directly opposite
to each other in the centrifuge
rotor buckets.

EmCyte Corporation
4331 Veronica S. Shoemaker Blvd., Fort Myers, FL 33916 USA www.emcyte.com
PL-42-85, Rev 4

STEP 5:

STEP 6:

Sapphire Series
Centrifuge:
AbsolutePRP/BMC
Platinum Series
Centrifuge:
AbsolutePRP/BMC
Executive Series
Centrifuge:
10 minutes
4400 RPM

BMC RBC interface reaches
7mL volume marker

Attach the 60mL syringe and aspirate the plasma until the bone marrow RBC interface reaches the 7mL volumemarker, then stop aspirating
REPEAT FOR EACH CONCENTRATING DEVICE:

7mL BMC

7mL BMC(Plasma & BMC buffycoat )(Plasma & BMC buffycoat )FOR EACH DEVICE
Attach the 12mL syringe and aspirate 7mL BMC(Rotate the syringe to re-suspend the BMC buffycoat into the plasma)
COLLECT A TOTAL OF 14mL BMC

EmCyte Corporation
4331 Veronica S. Shoemaker Blvd., Fort Myers, FL 33916 USA www.emcyte.com
PL-42-85, Rev 4