BIOMET Clotalyst Podręcznik - Strona 10

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Biomet Biologics

56 E. Bell Drive

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.

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.

01-50-1439

8. The safety and effectiveness of the device for bone healing and hemostasis

Date: 01/09

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.

Port #2

Draw Tube

Double Buoy

Port#1

Figure 1

GPS™ III Separator

Port #3

Tethered Cap on Port #2

Protective Inner

Pieces/syringe Tip