Port #2
Port #3
Tethered Cap on Port #2
Double Buoy
Protective Inner
Pieces/syringe Tip
Draw Tube
Port#1
Biomet Biologics
01-50-1439
56 E. Bell Drive
Date: 01/09
P.O. Box 587
Warsaw, Indiana 46581 USA
ClOtAlyst™ Kit WitH GPs™ iii sePArAtOr
AtteNtiON OPerAtiNG sUrGeON
NOte: FOr siNGle Use ONly. Discard the entire disposable kit after use
by an acceptable method for devices potentially contaminated with blood
products.
DesCriPtiON
The Clotalyst™ Kit with GPS™ III Separator(s) contains Clotalyst™ and GPS™
III Separator(s), Clotalyst™ Reagent, ACD-A and blood draw accessories. The
system produces autologous serum and autologous platelet-rich plasma (PRP).
Additional equipment used in the processing are the Clotalyst™ Heater and
Biomet Biologics™ centrifuge.
MAteriAls
Clotalyst™ separator
The Clotalyst™ Separator consists of medical grade polymers, silicone, acrylic,
polyester and borosilicate (glass beads) suitable for use in medical devices.
Clotalyst™ reagent (66% v/v ethyl alcohol, U.s.P./25mM Calcium Chloride,
U.s.P.)
Clotalyst™ Reagent is supplied and manufactured by ThermoGenesis Corp.,
Rancho Cordova, CA, for Biomet Biologics, Warsaw, IN. Please contact
ThermoGenesis Corp., Rancho Cordova, CA, at 1-800-783-8357 for further
information regarding the reagent.
the GPs™ iii separators and blood draw components
The materials used for syringes, needles, tubing and GPS™ III Separators
consist of medical grade polymers, elastomers and stainless steel suitable for
use in medical devices. Blood-draw components, when supplied in this kit, are
packaged, labeled and sterilized as indicated by the manufacturer’s labeling.
ACD-A (Anticoagulant Citrate Dextrose solution, solution A. U.s.P.)
ACD-A is an anticoagulant supplied by Citra Anticoagulants, Inc., Braintree,
MA, and manufactured by Cytosol Laboratories, Inc., Braintree, MA. For further
information regarding ACD-A Anticoagulant, please contact the supplier at
1-800-299-3411.
All Components in this Kit are latex-free
Please note: the ACD-A and Clotalyst™ Reagent included in this kit are only for
use with the Clotalyst™ Kit with GPS™ III Separators.
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
use requirements.
The Clotalyst™ Kit is designed for the preparation of autologous serum that is to
be mixed with the PRP and autograft or allograft for bone graft handling prior to
application to the orthopedic surgical site
CONtrAiNDiCAtiONs
1. Use as a dialyzer or for dialysis with a dialysate.
2. Direct connection to patient’s vascular system of circulating blood volume
.
WArNiNG AND PreCAUtiONs
1. Single use device. Do not reuse.
2. Use proper safety precautions to guard against needle sticks.
3. Do not use sterile components of this kit if package is opened or
damaged.
4. Store Clotalyst™ serum at 18-26o C (64.4-78.8o F) for up to 4 hours
prior to use. Discard remaining serum if not used within the provided time
frames.
5. The surgeon is to be thoroughly familiar with the equipment and the surgical
procedure prior to using this device.
6. The patient is to be made aware of the general risks associated with the
treatment and possible adverse effects.
7. The autologous serum exhibits thrombin activity and therefore must not be
injected into or otherwise allowed to enter the patient’s vascular system.
8. The safety and effectiveness of the device for bone healing and hemostasis
has not been established.
9. Follow manufacturers’ instructions when using a Biomet Biologics™
centrifuge (IEC centrifuge or the Drucker company centrifuge) and the
Clotalyst™ Heater. Outcomes utilizing centrifuges or heaters from other
manufactures are unknown.
POssiBle ADVerse eFFeCts FrOM BlOOD DrAW
1. Damage to blood vessels, hematoma, delayed wound healing and/or
infection.
2. Temporary or permanent nerve damage that may result in pain or
numbness.
3. Early or late postoperative infection.
sterility
The Clotalyst™ and GPS™ III Separators are terminally sterilized by exposure to
a minimum dose of 25 kGy gamma radiations. All other components supplied in
this system are sterilized by their respective suppliers using radiation or ethylene
oxide gas (ETO). Do not re-sterilize. Do not use after expiration date.
iNstrUCtiONs FOr Use
store serum at 18-26º C (64.4-78.8º F) for up to 4 hours prior to use.
Use standard aseptic technique throughout the following procedures.
PrOCeDUre ONe: Use of GPs™ iii separator (standard size) to prepare
platelet-rich plasma (PrP)(Figure 1)
1.
DrAW:
Draw 6ml ACD-A into 60ml syringe. Attach to 18-gauge apheresis
needle and prime with ACD-A. Slowly draw 54ml of the patient’s blood into
the 60ml syringe primed with ACD-A. Gently, but thoroughly, mix the whole
blood and ACD-A upon collection to prevent coagulation.
2.
lOAD: eNsUre BlOOD FrOM ONly ONe PAtieNt is PrOCesseD
Per sPiN, and that the GPs™ iii separator remains upright.
Unscrew
cap connected on center port #1. Remove and discard cap and green
packaging post. Slowly load blood filled 60ml syringe (6ml ACD-A mixed
with 54ml of the patient’s whole blood) into center port #1. Unscrew and
discard protective inner piece from white cap tethered to port #1. Screw
white cap onto port #1. Place GPS™ III Separator filled with anticoagulated
blood in a Biomet Biologics™ centrifuge.
3.
BAlANCe:
Fill blue GPS™ counterbalance tube (800-0508) with 35-
60ml of sterile saline/water (equal to amount of whole blood plus ACD-A
dispensed in the platelet concentrator). Place filled counterbalance directly
opposite from the GPS™ III Separator in the centrifuge.
4.
sPiN:
Close centrifuge lid. Set RPM to 3.2 (x1000) and the time to 15
minutes. Press the start button. Once spin is complete, open the centrifuge
and remove the GPS™ III Separator.
5.
eXtrACt PPP:
Unscrew and save yellow cap on port #2. Connect 30ml
syringe to port #2, invert GPS™ III Separator, and extract platelet-poor
plasma (PPP). Remove 30ml syringe from port #2, cap with a sterile syringe
cap and set aside. Replace yellow cap on port #2.
6.
sUsPeND PrP:
Holding GPS™ III Separator in the upright position,
unscrew red cap on port #3. Attach sterile 10ml syringe to port #3. Extract
2ml of PRP into the 10ml syringe. Leave the syringe attached. Shake
GPS™ III Separator gently for 30 seconds.
7.
eXtrACt PrP:
Immediately after suspending the platelets, extract the
remaining PRP into the attached 10ml syringe. Remove 10ml syringe form
port #3 and cap with a sterile syringe cap.
Figure 1
GPS™ III Separator
The information contained in this package insert was current on the date this brochure was printed. However, the package insert may have been revised after that date. To obtain a current package
insert, please contact Biomet at the contact information provided herein.
PROCEDURE ONE: Use of GPS™ III Mini Separator to prepare platelet-rich
plasma (PRP)(Figure 1)
1.
DRAW
: Draw 3ml ACD-A into 30ml syringe. Attach to 18-gauge apheresis
needle and prime with ACD-A. Slowly draw 27ml of the patient’s blood into
the 30ml syringe primed with ACD-A. Gently, but thoroughly, mix the whole
blood and ACD-A upon collection to prevent coagulation.
2.
LOAD: ENSURE BLOOD FROM ONLY ONE PATIENT IS PROCESSED
PER SPIN, and that the GPS™ III Mini Separator remains upright.
Unscrew cap connected on center port #1. Remove and discard cap and
green packaging post. Slowly load blood filled 30ml syringe (3ml ACD-A
mixed with 27ml of the patient’s whole blood) into center port #1. Unscrew
and discard protective inner piece from white cap tethered to port #1.
Screw white cap onto port #1. Place GPS™ III Mini Separator filled with
anticoagulated blood in a Biomet Biologics™ centrifuge.
3.
BALANCE
: Fill blue GPS™ counterbalance tube (800-0505) with 30ml of
sterile saline/water (equal to amount of whole blood plus ACD-A dispensed
in the GPS™ III Mini Separator). Place filled counterbalance directly
opposite from the GPS™ III Mini Separator in the centrifuge.
4.
SPIN
: Close centrifuge lid. Set RPM to 3.2 (x1000) and the time to 15
minutes. Press the start button. Once spin is complete, open the centrifuge
and remove the GPS™ III Mini Separator.
5.
EXTRACT PPP
: Unscrew and save yellow cap on port #2. Connect 30ml
syringe to port #2, invert GPS™ III Mini Separator, and extract platelet-poor
plasma (PPP). Remove 30ml syringe from port #2, cap with a sterile syringe
cap and set aside. Replace yellow cap on port #2.
6.
SUSPEND PRP
: Holding GPS™ III Mini Separator in the upright position,
unscrew red cap on port #3. Attach sterile 10ml syringe to port #3. Extract
1ml of PRP into the 10ml syringe. Leave the syringe attached. Shake
GPS™ III Mini Separator gently for 30 seconds.
7.
EXTRACT PRP
: Immediately after suspending the platelets, extract the
remaining PRP into the attached 10ml syringe. Remove 10ml syringe form
port #3 and cap with a sterile syringe cap.
PROCEDURE TWO: Use the Clotalyst™ Separator to prepare the autologous
serum (Figure 2)
1.
TURN ON
: The Clotalyst™ Heater to achieve the appropriate operating
temperature 25°C (77°F).
2.
DRAW
: Draw 1ml ACD-A into a sterile 10ml syringe. Attach to the 18-gauge
apheresis needle. Slowly draw 11ml of the patient’s blood into the 10ml
syringe primed with ACD-A. Gently, but thoroughly mix the whole blood
and ACD-A upon collection to prevent coagulation.
NOTE: The 10ml syringe provided has graduation markings to 12ml.
3.
LOAD Clotalyst™ REAGENT: Ensure the Clotalyst™ Separator remains
upright.
Unscrew and discard blue cap on port #2, attach Clotalyst™
Reagent syringe and completely transfer contents (4 ml) through port #2.
Remove and discard reagent syringe. Unscrew and discard protective inner
piece from white cap tethered to port #2. Screw white cap onto port #2.
NOTE: Dislodging duckbill valves attached to ports #2 and #3 of the
Clotalyst™ Separator during steps 3 and 4 can occur. This is NOT
detrimental to the procedure.
4.
LOAD BLOOD: ENSURE BLOOD FROM ONLY ONE PATIENT IS
PROCESSED
Unscrew and discard red cap on port #3. Attach and slowly
transfer contents of anticoagulated blood-filled syringe (1ml ACD-A mixed
with 11ml of patient’s whole blood) through port #3. Unscrew and discard
protective inner piece from white cap tethered to port #3. Screw white cap
onto port #3.
5.
MIX
: Without producing foam gently invert Clotalyst™ Separator 12 times
to thoroughly mix the anticoagulated blood with the Clotalyst™ reagent
and glass beads.
6.
INCUBATE
: Holding the Clotalyst™ Separator on its side ensures the glass
beads are distributed evenly. Place the Clotalyst™ Separator in the heater
and begin the incubation cycle (25 minutes at 25°C).
7.
SHAKE
: Remove Clotalyst™ Separator from the heater and shake
vigorously for 5 second, thus dislodging and braking up any coagulum
that may be present in the separator. Place the Clotalyst™ Separator in a
Biomet Biologics™ centrifuge.
8.
BALANCE
: Place the orange Clotalyst™ counterbalance (800-0760)
directly opposite from the Clotalyst™ Separator in the centrifuge.
9.
SPIN
: Close centrifuge lid. Set RPM to 3.2 (x 1,000) and the time to 5
minutes. Press the start button. Once the spin is completed, open the
centrifuge.
10.
EXTRACT SERUM
: Gently remove the Clotalyst™ Separator without
disturbing the stratified layers. Holding Clotalyst™ Separator upright
unscrew and remove the yellow cap on center port #1. Attach a sterile
10ml syringe to center port # 1. To maximize serum volume output gently
tilt Clotalyst™ Separator toward port #3 while slowly extracting 5-6ml
serum Remove the 10ml syringe from center port #1 and attach sterile
syringe cap
NOTE: If the extraction tube becomes plugged prior to achieving
5-6ml of output, the Clotalyst™ Separator can be placed back in the
centrifuge for one minute at 3200 RPMs to dislodge the clot, allowing
the remaining serum to be extracted.
11.
STORAGE
: Store serum at 18-26° C (64.4-78.8°F) for up to 4 hours prior to
use. Discard remaining serum if not used within the provided time frames.
Figure 2
Clotalyst™ Separator
Caution
: Federal law (USA) limits this device to sale, distribution, or use by or on
the order of a physician.
Comments regarding this device can be directed to Attn: Regulatory Dept.,
Biomet, Inc., P.O. Box 587, Warsaw, IN 46581 USA, Fax: 574-372-3968.
All trademarks herein are the property of Biomet, Inc., or its subsidiaries unless
otherwise indicated.
Manufacturer
Date of Manufacture
Do Not Reuse
Consult Accompanying Documents
Sterilized using Ethylene Oxide
Sterilized using Irradiation
Sterile
Sterilized using Aseptic Technique
Sterilized using Steam or Dry Heat
Expiry Date
WEEE Device
Catalogue Number
Lot Number
U
U
The information contained in this package insert was current on the date this brochure was printed. However, the package insert may have been revised after that date. To obtain a current package
insert, please contact Biomet at the contact information provided herein.
Port # 3
Port # 2
Glass Beads
Duckbill
Protective Inner
Pieces/syringe Tip
Port # 1
Filter
Tethered Cap
Extraction Tube
