PPT-I
Platelet Preparation System
INTENDED USE
Safe and rapid preparation of autologous platelet-rich plasma (PRP) from a small
sample of blood at the patient point of care. The PRP is mixed with autograft and/or
allograft bone prior to application to a bony defect for improving handling
characteristics.
6. Needle disposal container for used needle or needle/holder combination
7. 2-5ml or 10 ml Syringes
8. 2 Blunt needles or 1 sharp needle
9. Optional: filter sleeve
REQUIRED EQUIPMENT NOT PROVIDED FOR SPECIMEN PROCESSING
1. Centrifuge capable of generating 1200 G (RCF) (spun for 12 minutes) or 1500 G (RCF) (spun
for 10 minutes) at the tube bottom. A horizontal centrifuge head is preferred for barrier quality
with Gel Tubes.
.
PREPARATION FOR SPECIMEN COLLECTION
Be sure the following materials are readily accessible before performing venipuncture:
1. See required equipment above.
2. Tubes.
PRODUCT DESCRIPTION
Vacuum tube for Platelet Rich Plasma (PRP) preparation with gel and
anticoagulant.
LIMITATIONS OF SYSTEM
The quantity of blood draw varies with altitude, ambient temperature, barometric pressure, tube
age, venous pressure, and filling technique. Tubes with draw volume smaller than the apparent
dimensions indicated may be filled more slowly than tubes of the same size with greater draw
volume.
For those tubes subjected to centrifugation to generate plasma or serum for testing, standard
processing conditions do not completely sediment all cells, whether or not barrier gel is present.
NOTE: FOR SINGLE USE ONLY. Discard the entire platelet separation tube after a single
use by an acceptable disposable method for devices potentially contaminated with blood
products.
PRECAUTIONS
1. PRP should be applied to the same patient whom the blood was drawn from!!!
2. Storage of tubes containing blood at or below 0°C may result in tube breakage.
3. Storage of tubes above 40°C may damage the gel stability.
4. Do not remove conventional rubber stoppers by rolling with a thumb. Remove stoppers with
a twist and pull motion.
5. Do not use tubes if foreign matter is present.
6. All liquid preservatives and anticoagulants are clear. Do not use tubes after their expiration
date.
7. Do not re-sterilize and do not attempt to clean this product.
8. Do not use products if pouch is damaged.
9. Use prepared platelet concentrate material within 4 hours after drawing blood from patient.
CAUTION
1. Practice Universal Precautions. Process all procedures under controlled environment, use
gloves, gowns, eye protection, other personal protective equipment and engineering controls to
protect from blood splatter, blood leakage and potential exposure to blood-borne pathogens.
2. All glass has the potential for breakage. Examine all glass for potential damage in transit
before use and take precautionary measures during handling.
3. Handle all biologic samples and blood collection "sharps" (lancets, needles, luer adapters, and
blood collection sets) according to the policies and procedures of your facility. Obtain
appropriate medical attention in the event of any exposure to biologic samples (for example,
through a puncture injury) since they may transmit viral hepatitis, HIV (AIDS), or other
infectious diseases. Utilize any built-in used needle protector, if the blood collection device
provides one. Estar Technologies Ltd. does not recommend reshielding used needles.
4. Discard all blood collection "sharps" in biohazard containers approved for their disposal.
5. Transferring a sample from a syringe to a tube is not recommended. Additional manipulation
of sharps increases the potential for needlestick injury, in addition, depressing syringe plunger
during transfer can create a positive pressure, forcefully displacing the stopper and sample and
causing a potential blood exposure. Using a syringe for blood transfer may also cause over or
underfilling of tubes, resulting in an incorrect blood-to-additive ratio and potentially incorrect
analytic results. Tubes with draw volume smaller than the apparent indicated dimensions may
not be filled to their stated volume when filled from a syringe. The laboratory should be
consulted regarding the use of these samples.
6. Underfilling of tubes will result in an incorrect blood-to-additive ratio and may lead to
incorrect analytic results or poor product performance.
POSSIBLE ADVERSE EFFECTS
1.
Damage to blood vessels, hematoma, infection and/or irritation.
2.
Temporary or permanent nerve damage that may result in pain or numbness.
3.
As with any injection-based treatment, infection is a slight possibility.
STORAGE
Store tubes at 4-25°C (39-77°F), unless otherwise noted on the package label.
SPECIMEN COLLECTION AND HANDLING
Read this entire circular before performing venipuncture.
REQUIRED ACCESSORIES
1. Practice Universal Precautions. Use gloves, eye protection, coats or gowns, and other
appropriate apparel for protection from exposure to blood-borne pathogens or other potentially
infectious materials
2. Holder, Luer Adapter and PSV Set (our vacu10 or other available devices for venous blood
collection via vacuum)
3. Alcohol swab for cleansing site
4. Dry sterile gauze
5. Tourniquet
Version 15-US, 03.01.15
PREVENTION OF BACKFLOW
Since the evacuated blood collection tubes contain chemical additives, it is important to avoid
possible backflow from the tube, with the possibility of adverse patient reactions. To guard
against backflow, observe the following precautions:
1. Place patient's arm in a downward position.
2. Hold tube with the stopper uppermost.
3. Release tourniquet as soon as blood starts to flow into the tube.
4. Make sure tube additives do not touch stopper or end of the needle during venipuncture.
VENIPUNCTURE TECHNIQUE AND SPECIMEN COLLECTION
GENERAL INSTRUCTIONS
WEAR GLOVES DURING VENIPUNCTURE AND WHEN HANDLING BLOOD
COLLECTION TUBES TO MINIMIZE EXPOSURE HAZARD.
1. Select a PPT-I tube.
2. Gently tap tubes containing additives to dislodge any material that may be adhered to the
stopper.
3. Place tube into holder. Note: Do not puncture stopper.
4. Select site for venipuncture.
5. Apply tourniquet. Prepare venipuncture site with an appropriate antiseptic. DO NOT
PALPATE VENIPUNCTURE AREA AFTER CLEANSING.
6. Place patient's arm in a downward position.
7. Remove needle shield. Perform venipuncture WITH ARM DOWNWARD AND TUBE
STOPPER UPPERMOST.
8. Push tube onto needle, puncturing stopper diaphragm. Center tubes in holder when
penetrating the stopper to prevent sidewall penetration and resultant premature vacuum loss.
9. REMOVE TOURNIQUET AS SOON AS BLOOD APPEARS IN TUBE. DO NOT
ALLOW CONTENTS OF TUBE TO CONTACT THE STOPPER OR END OF THE
NEEDLE DURING PROCEDURE.
Note: Blood may occasionally leak from the needle sleeve. Practice Universal Precautions to
minimize exposure hazard.
If no blood flows into tube or if blood ceases to flow before an adequate specimen is collected,
the following steps are suggested to complete satisfactory collection:
a. Push the tube forward until tube stopper has been penetrated, if necessary, hold
in place to ensure complete vacuum draw.
b. Confirm correct position of needle cannula in vein.
c. If second tube does not draw, remove needle and discard. Repeat procedure
from Step 1.
10. Once the tube has been filled to its stated volume and blood flow ceases, remove the tube
from holder.
11. Remove needle from vein, applying pressure to puncture site with dry sterile swab until
bleeding stops.
12. Once clotting has occurred, apply bandage if desired.
13. After venipuncture, the top of the stopper may contain residual blood. Take proper
precautions when handling tubes to avoid contact with this blood. Any needle holder that
becomes contaminated with blood is considered hazardous and should be decontaminated with
bleach or disposed of.
14. Dispose of the used needle using an appropriate disposal device. DO NOT RESHIELD.
Reshielding of needles increases the risk of needlestick injury and blood exposure.
15. Turn the filled tube upside-down and return it to an upright position. That is one complete
inversion.
16. For proper additive performance, invert tube 5 times. Do not shake. Vigorous mixing may
cause foaming or hemolysis. In tubes with anticoagulants, inadequate mixing may result in
platelet clumping, clotting and/or incorrect test results.
CENTRIFUGATION
Caution: Do not centrifuge glass tubes at forces above 1550 RCF in a horizontal head (swinging
bucket) centrifuge as breakage may occur. Follow manufacturer instruction when using
centrifuge. Glass tubes may break if centrifuged above 1550 RCF in fixed angle centrifuge
heads.
Use of tubes with cracks or chips or excessive centrifugation speed may cause tube breakage,
with release of sample, droplets, and aerosols into the centrifuge bowl. Release of these
potentially hazardous materials can be avoided by using specially designed sealed containers in
which tubes are held during centrifugation. Centrifuge carriers and Inserts should be of the size
specific to the tubes used. Use of carriers too large or too small may result in breakage.
Ensure that tubes are properly seated in the centrifuge carrier. Incomplete seating could result
in separation of the stopper closure from the tube or extension of the tube above the carrier.
Tubes extending above the carrier could be caught on centrifuge head, resulting in breakage.
Balance tubes to minimize the chance of glass breakage.
Always allow centrifuge to come to a complete stop before attempting to remove tubes. When
centrifuge head has stopped, open the lid and examine for possible broken tubes. If breakage is
indicated, use mechanical device, such as forceps or hemostat to remove tubes. Caution: Do
not remove broken tubes by hand. See centrifuge instruction manual for disinfection
instructions.
RCF is related to centrifuge speed setting (rpm) using either of the following equations:
rpm 
RCFx10
1.12 xr
5
or approximately
rpm 
r
CENTRIFUGATION SPEED AND TIME
RCF(g)
TIME (min)
PPT-I Vacuum Tube – Model 614B
1200
PPT-I Vacuum Tube – Model 642VES
1496
Choose Speed and Time based on Centrifuge
RCF = Relative Centrifugal Force, g'
12
10
Authorized Representative in the
European Community
Caution, consult
accompanying documents
Keep away from sunlight
Keep dry
Temperature limitation
Fragile, Handle with care
Do not Use if Package is Damaged
CENTRIFUGE RADIUS I SPEED
SPEED
(rpm)
RADIUS
(cm)
SPEED
(rpm)
7
3750
17
2400
8
3500
18
2350
9
3300
19
2280
10
3150
20
2200
11
3000
21
2160
12
2900
22
2100
13
2750
23
2060
14
2650
24
2030
15
2550
25
2000
16
2500
26
1950
1. After centrifugation remove cap from tube.
2. Invert the PRP tube gently 6 to 7 times.
3. Removal of PPP phase. Place the tube in the rack. Attach the 10 cm blunt needle to 10 ml
syringe. Open the tube and place the cap upside down on a sterile surface (to maintain sterility).
Insert 10 cm needle until you reach the surface of plasma. Then carefully draw plasma from the
surface for about 50% to 80%, leaving 1.5 to 3.5 ml in the tube. You are now removing the PPP
phase. Do not insert the needle too deep from the surface of plasma. After drawing PPP into the
syringe, discard this PPP.
4. PRP harvesting: Using the same 10 ml syringe with 10 cm blunt needle, you will reach the
remaining plasma. You are now handling PRP. Suspend the PRP fraction by gently mixing it
through pumping up and down the fluid against the gel surface and around the tube wall to lift
platelet on the gel surface. Carefully repeat this process 3 to 4 times. Alternatively, close the
tube by re-placing the cap and invert it 10 times. This is a very important process to harvest as
many platelets as possible. The PRP is now ready for use.
5. Optional: place the tube in the rack. Take the sleeve filter, peel sterile cover to a half way
from filter side to expose bottom side of sleeve. Hold cap with sterile cover on and insert filter
into the tube until filter gently touches the gel surface. PRP now enters inside the sleeve
chamber. Insert a new 10 cm blunt needle into the sleeve chamber through MonoCap® hole to
collect the PRP. The PRP is now ready to use.
CAUTION: Federal law (USA) restricts this device to sell by or on the order of a physician.
It is the laboratory's ultimate responsibility to determine reference intervals for all analytes based
upon the tubes used for sample collection by that laboratory. The clinical laboratory should
establish/verify its reference ranges if changing specimen collection tube types and sizes, as this
could potentially affect analytic results from patient samples.
Catalog Number
FDA cleared 510(k) Class II medical device. Eclipse PRP is intended for the safe and rapid
preparation of autologous platelet-rich plasma (PRP) from a small sample of blood at the
patient point of care. The PRP is mixed with autograft or allograft bone prior to application to
an orthopedic surgical site. 510(k) number: BK110035
Estar Technologies Ltd., 15, Hamerkava St. Holon, Israel
5885111
Tel: +972-3-5596414/35/36, Fax: +972-3-5596424
E-mail: aaron@estar-medical.com
BALANCE
PRP SEPARATION
REF
Federal (USA) law restricts
this device to sale by or on the
order of a physician
The flow properties of the barrier material are temperature-related. Flow may be impeded if
chilled before or during centrifugation. Gel separation tubes should be centrifuged no later than
2 hours after collection.
Tubes should not be recentrifuged once barrier has formed. Barriers are more stable when tubes
are spun in centrifuges with horizontal (swinging bucket) heads than those with fixed angle
heads.
When processing odd number of PPT-I tubes place filled contra balance tube with the same
weight directly opposite from the platelet preparation tube in the centrifuge.
When processing even number of PPT-I tubes, place tubes directly opposite from each other in
the centrifuge.
Manufacturer
Do not re-sterilize
Latex Free
RADIUS
(cm)
Version 15-US, 03.01.15
Do not reuse
Use by
Recyclable package
The following table relates radius of centrifuge arm to required speed in order to obtain the
appropriate g-force.
Footnotes
PRP - Platelet Rich Plasma
PPP – Platelet Poor Plasma
Symbols & Mark Key
Method of Sterilization
Using Irradiation
10,000
where "r", expressed in cm, is the radial distance from the center of the centrifuge head to the
bottom of the tube. The following table gives recommended centrifuge speed and time.
PRODUCT
Batch Code
Manufactured for:
Eclipse Aesthetics, LLC
13988 Diplomat Dr., Suite 160
Dallas TX 75234
Tel: 800-759-6876
Fax: 866-558-0415
E-mail: info@eclipsemed.com
Version 15-US, 03.01.15