BIOMET Clotalyst Handbuch - Seite 11

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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

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.

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.

Port # 1

Port # 2

Duckbill

Extraction Tube

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

U U

WEEE Device

Catalogue Number

Lot Number

Filter

Port # 3

Tethered Cap

Protective Inner

Pieces/syringe Tip

Glass Beads