REIN No Additive Blood Collection Tubes
(PRF - 2 Tubes) IFU
REIN PRP Twin
(2 Tubes) IFU
REIN
NO ADDITIVE BLOOD COLLECTION TUBE MODEL
INSTRUCTIONS FOR USE
Reference No: OM-R1-1002
PRODUCT AND INTENDED USE
It enables the safe and rapid production of platelet-rich fibrin without the use of anticoagulants. Platelet-rich fibrin can be applied locally to both soft and hard tissues in clinical settings and is used to support tissue healing, facilitate the faster repair of damaged tissues, and stimulate tissues to accelerate natural healing processes.
PRODUCT CONTENTS
2 pieces 10 ml No Additive Blood Collection Tube with vacuum
PRODUCT PERFORMANCE AND CLINICAL INFORMATION
Platelet-rich fibrin therapy is an autologous treatment for the healing of bone and soft tissues, achieved by re-injecting platelet-rich tissue into the patient. The blood in the tube is processed using a centrifuge, and the platelet-rich fibrin layer is collected by the user. Due to its platelet content, it is rich in growth factors, and these growth factors support the rapid healing of damaged tissue. Clinical Evaluation Reports and Risk Analysis Reports confirm that the product is clinically effective and safe.
WARNINGS AND PRECAUTIONS
1. Be sure to store the products under the storage conditions specified by the manufacturer.
2. Do not use products that have been opened or damaged. If any product is dropped on the floor, do not use it and dispose of it as medical waste.
3. Do not use products past their expiration date.
4. This is a single-use device intended for each individual patient; do not reuse it.
5. The tubes have been sterilized first with gamma radiation and then with ethylene oxide (EO); they may be used in controlled environments. Do not perform a second sterilization process.
6. Intended for medical use only. Do not use for any other purpose.
7. Use of the products outside their indicated indications is contraindicated.
8. It should only be used by physicians with a medical license.
9. If you are taking anti-inflammatory or blood-thinning medications, consult your physician regarding medication use before and after PRF treatment.
10. Follow your physician’s recommendations regarding the day of treatment, as well as before and after.
11. The user must have detailed knowledge of the equipment and surgical procedure before using this device.
12. The patient must be informed about the risks and potential side effects associated with the treatment.
13. Follow the manufacturer’s instructions for the centrifugation process.
14. The centrifuge to be used must be calibrated. If a fixed-angle centrifuge is to be used, one with an angle of at least 45 degrees must be used.
15. Do not forget to place a balance tube in the rotor if an odd number of tubes are to be cenrifuged.
16. The tubes are vacuum-sealed; therefore, do not open the tube caps. Non-vacuum tubes must not be used.
17. Pay attention to the proper usage method based on the type of platelet-rich fibrin (PRF) you wish to obtain. Since there is no anticoagulant in the tube, coagulation begins immediately. Before injection, check the viscosity of the platelet concentrate to ensure it is in an injectable state.
18. Pay attention to the sample volume to account for the possibility of vacuum loss.
19. After the blood collection procedure, the tube is inserted with a short needle tip so that it does not come into contact with the blood, thereby releasing the vacuum, in case there is residual vacuum in the tubes.
20. Take appropriate safety precautions against needle stick injuries when using the needles provided with the product.
21. Do not dispose of this product in unsorted municipal waste.
DIRECTIONS FOR USE AND INDICATIONS
This product can be used in various medical applications, including dermatology, physical therapy, urology, gynecology, ophthalmology, various surgical specialties (orthopedics, plastic surgery, dentistry and maxillofacial surgery, and cardiovascular surgery), and hair transplantation procedures.
USAGE
1. Open the box and blister.
2. Perform the blood collection procedure using No Additive Blood Collection Tubes. These are vacuum tubes. The blood collection process will stop automatically once sufficient amount of blood has been collected.
3. Since No Additive Blood Collection Tubes do not contain any anticoagulant, place them in the centrifuge immediately after the blood collection procedure.
4. Centrifuge rotors must be compatible with 16x100 mm No Additive Blood Collection Tubes.
5. For injectable platelet-rich fibrin, centrifuge at 1000G for 4 minutes.
6. Insert a short needle into the tube cap so that the tip does not touch the plasma, and release the vacuum from the tube. Then, using a long needle and syringe, collect the injectable platelet-rich fibrin without aspirating red blood cells (RBCs). (Do not open the tube cap unless laminar flow conditions are maintained.)
Inject the platelet concentrate into the patient without delay.
PATIENT PROFILE
Platelet-rich fibrin is an autologous treatment technique that can be administered to patients approved by a physician and under the physician’s supervision. Because the treatment is autologous, it prevents the transmission of various infectious diseases and ensures a safe procedure.
USER PROFILE
The device should be used by a physician or physicians with sufficient experience in its use.
CONTRAINDICATIONS
PRF application is not recommended in the presence of any of the following conditions:
- Thrombotic Dysfunction Syndrome
- Critical Thrombocytopenia
- Hypofibrinogenemia
- Hemodynamic instability
- Autoimmune diseases
- Malignancy
- Sepsis
- Acute and chronic infections
- Chronic liver disease
- Anticoagulation Therapy (e.g., ASA therapy)
Note: This product should not be used during pregnancy or on newborns.
RISKS AND SIDE EFFECTS
According to risk assessment, management and analysis reports conducted during the product’s production phase, temporary pain, temporary bruising, or swelling may occur in the application area. Therefore, improper application by non-professionals or failure to adhere to sterility protocols may result in various injuries and/or infections.
SHELF LIFE
The expiration date printed on the product applies to its shelf life.
Explanation of Symbols on the Box Label
