Reference Number
KIT
NEW
NEW S GENERAL GUIDELINES
Intended Use : Contraindications : Recommended Centrifugation Use:
The TriCell PRP Blood Separation Kit is designed to be used for the safe and The use of the TriCell PRP Blood Separation Kit may be contraindicated when The TriCell PRP Blood Separation Kit is intended for use with an appropriate
rapid preparation of autologous Platelet Rich Plasma (PRP) from a sample of there is clinical or laboratory evidence of septicemia, or for patients who have swing bucket centrifuge. Refer to the Centrifuge Operator's Manual for
blood at the patient's point of care especially the early stage of osteoarthritis taken aspirin or other medications that alter platelet function within 3 days additional information concerning operation and maintenance of the centrifuge,
knee and other orthopedic indications. prior to surgery, or patients with disorders associated with platelet dysfunction. along with additional warnings and precautions.
General Precautions:
1. The TriCell PRP Blood Separation Kit is sterile. Do not resterilize! 13. Attach a 21 gauge needle cannula to the blood-filled syringe and dispense contents (at 1ml per second) through
2. The TriCell PRP Blood Separation Kit is for single patient use only. Discard all unused components at the end of the Injection Port of the the TriCell PRP Blood Separation Kit at a 30˚ angle (Fig. 2a).
the procedure. WARNING: Inject blood at a 30˚ angle to ensure proper displacement of blood. Failure to use 21 G may result in leakage.
3. Do not reuse the TriCell PRP Blood Separation Kit! Reuse may lead to infection or illness/injury/death. 14. After the blood injection is complete, pull back the piston of the syringe to remove the remaining blood at the
4. The TriCell PRP Blood Separation Kit is a non-active and non-implantable device. tip of the needle. Otherwise, the blood remaining on the needle may spill out. And, make sure to close the Air
5. Inspect the TriCell PRP Blood Separation Kit prior to use and do not use if the package has been damaged or Vent Cap (Fig. 2c).
opened. 15. If RBC/Buffy Coat is too high in Plasma Chamber (Chamber #2) after 1st centrifugation, centrifuge again with
6. Always follow the aseptic technique when opening a sterile container. Wipe the TriCell PRP Blood Separation Kit 2700RPM, 2min (Fig. 3).
chamber access areas with an alcohol pad prior to entry. 16. Do not turn the RBC Chamber Cap (Chamber #1) to the left during this process as this may cause leakage (Fig. 4).
7. Aseptic technique, proper skin preparation, and continued protection of the venipuncture site are essential. 17. If the Lower Plasma Chamber (Chamber #2) + Upper Plasma Chamber (Chamber #3) is not locked tightly, blood may
8. Dispose of blood-contaminated disposables according to hospital policies and procedures for biological waste. become mixed (Fig. 5).
Use universal precautions. 18. W hen operating the PRP Chamber Cap (Chamber #5), do not turn it to the right. Doing so may cause leakage (Fig. 6).
9. Separated blood products should be used within 4 hours of collection. 19. After the 1st centrifugation, close the RBC Chamber (Chamber #1) and manually swirl it sufficiently. This can
10. After each step, maintain the TriCell PRP Blood Separation Kit in an upright position. Tilting the kit may disturb help activate cells sinking further in the chamber (Fig. 7).
the fluid layers and affecting process results. 20. If the Upper Plasma Chamber (Chamber #3) + PRP Chamber (Chamber #4) is not locked tightly, blood may become
11. Open and close the Air Vent Cap precisely (Fig. 2a, 2c, 4a, 5b). mixed (Fig. 9).
WARNING: Failure to close Air Vent Cap may result in biocontamination exposure. 21. When extracting PRP from the PRP Chamber (Chamber #4), extract with the PRP Chamber Cap (Chamber #5)
12. If the Air Vent Cap is not closed properly, it may cause leakage. facing upward. Working downwards may cause leakage (Fig. 10).
SYMBOLS
REF Catalog Number Manufacturer Date of Manufacture Temperature Limits Do Not Use if Package Is Damaged
LOT Batch Code EC REP EC Representative Use by STERILE R Sterilized using irradiation Keep dry, Keep away from sunlight
Do Not Reuse Consult Instructions for Use Do Not Resterilize QTY Quantity of devices
Instruction for Use
Process Steps
Structure
STEP. 01
KIT, NEW NEW S
30°
Anticoagulant 3ml 2ml
Blood 27ml 13ml
Total 30ml 15ml
Protective Foil
STEP. 01 STEP. 02 STEP. 03
a. P
refill syringe with a. Open Air Vent Cap. a. Load centrifuge with TriCell PRP Chamber Cap (Chamber #5)
anticoagulant (i.e. ACDA) and b. Inject blood at 30˚ angle (21G PRP and opposing balance kit
draw blood according to the needle). (equal weight). PRP Chamber (Chamber #4)
amount indicated on the table. c. Close Air Vent Cap. b. Close lid, run 3200RPM,
5MIN.
Air Vent Cap
Injection Port
hold
turn
hold
turn
turn
Upper Plasma Chamber (Chamber #3)
hold
Lower Plasma Chamber (Chamber #2)
STEP. 04 STEP. 05 STEP. 06
RBC Chamber (Chamber #1)
a. Open Air Vent Cap. a. Turn and tighten the Chamber Rotate Chamber #5 to set final
b. Rotate Chamber #1 to adjust #2 to lock off RBC. Plasma Product volume (1-4ml).
Buffy Coat to the desired b. Close Air Vent Cap. Basic setting = 4ml.
location.
hold
turn
STEP. 07 STEP. 08 STEP. 09 STEP. 10
a. G
ently swirl to mix Plasma a. Re-load centrifuge with Turn and tighten Chamber #4 to a. Invert TriCell PRP, place on a
with selected Buffy Coat. inverted TriCell PRP and lock off excess plasma. flat surface.
b. Invert TriCell PRP. balance kit. [Do not turn Chamber #5] b. Peel back Protective Foil.
b. Close lid, run 3300RPM, 3MIN. c. Harvest Plasma Product with
21G needle syringe.
WARNING : Failure to precisely perform steps 1-10 may result in undesired results, clots, leaks, vibration, internal pressure build-up, and/or bio-hazard exposure www.rev-med.co.kr
REV-MED Inc. | #301, #306, #604, 464, Dunchon-daero, Jungwon-gu, Sungnam-si, Gyeonggi-do, Republic of Korea | Zip: 13229 | Tel: +82 31. 741. 0996. | E-Mail: [email protected]
EC REP JaviTech e.K. | Sachsenhausener Straße 16, 65824 Schwalbach am Taunus, Germany RM-IFU-PRP-A (rev.1.7 2022-09-08)
