MEDICAL TREATMENT SET FOR ACQUIRING PLATE-RICH FIBRIN
The use of a specialized DIVES MED i-PRF kit allows to obtain platelet-rich fibrin, i.e., an autologous tissue stimulator containing an increased number of platelets and mesenchymal stem cells. The i-PRF concentrate is obtained by taking blood directly from the patient and its subsequent centrifugation. The centrifugation process creates a three-dimensional spatial structure composed of platelets and fibrin fibres. The obtained i-PRF concentrate with exceptional regenerative and rejuvenating potential is reimplanted into the patient’s body. This triggers a series of auto-repair reactions, activation of fibroblasts for collagen synthesis, active angiogenesis, and stimulation of mesenchymal stem cells.
The main advantage of the therapy is its autologous safety, with no risk of allergies, intolerance, or rejection. Platelet rich fibrin DIVES MED i-PRF is relatively widely used in maxillofacial surgery, orthopaedics, as well as in sports and aesthetic medicine.
The kit includes 4 sterile, pyrogen-free, polycarbonate tubes with a capacity of 9 ml. The tubes enable a vacuum, completely closed blood collection system, which increases the safety of the procedure and prevents material contamination. Each of the tubes is
packed in a separate blister, which allows the set to be divided into independent procedures. Tubes are intended for
reimplantation procedures and are marked with a medical certificate of group II B in vivo. Additionally, the kit includes 2 disposable treatment instrument sets containing:
– butterfly needle with a tubing
– 21G 0.8x30mm system needle for vacuum blood collection
– i-PRF 20G / 0.9x70mm collection needle
– luer-lock syringe with a capacity of 1 ml
– luer-lock syringe with a capacity of 3 ml
– 2 injection needles 30G / 0.3x13mm
– 2 injection needles 30G / 0.3x4mm
HOW TO USE:
Stage 1: Collection of Whole Blood
Before starting blood sampling, disinfect the skin. Open the set of treatment instruments and the blister with the tube. Make a venous puncture with the included phlebotomy accessories, then connect the tube with the holder. The tube will start to fill with blood automatically, up to the volume of about 9ml. After filling, disconnect the tube and connect another if necessary. Place contaminated collection instruments in a medical waste container and dispose of according to procedures for handling blood-contaminated materials.
Stage 2: Centrifugation
Place the received test tubes evenly opposite in the centrifuge. Centrifuge for 3 minutes at 50 g centrifugal force (RCF). Set the rotational speed according to the recommendations of the centrifuge manufacturer.
Stage 3: Collection i-PRF
The action of centrifugal force will arrange the morphotic parts according to the gravitational weight and obtain 2 fractions. There will be red blood cells at the bottom of the tube and platelet-rich fibrin (i-PRF) on top. Use a 20G 0.9x70mm needle and draw fibrin directly into the syringe. From the separation of 1 test tube, you will get a total of about 0.5-0.7 ml of platelet-rich fibrin (i-PRF).
Stage 4: Injection
The resulting i-PRF concentrate is immediately injected into the tissues. Administration of i-PRF up to 3 minutes from the moment of collection ensures full biological activity of the solution. After this time, the fibrin solidifies and becomes useless and impossible to reimplant further.
Stage 5: Disposal
After use, dispose of all components of the procedure set in accordance with the guidelines for handling materials potentially contaminated with blood. Take care of unprotected needles and other contaminated treatment instruments.
DOSAGE AND INJECTION METHOD:
Injections into the articular space should be performed with medical imaging and the same precautions as for any other intra-articular injection. Immediately after the injection, the patient should refrain from any activities that weigh on the joints. Intensive physical activity should be limited within 48 hours after the procedure. To obtain optimal treatment effects, it is recommended to use 2 treatment tubes for 1 joint.
Perform intradermal injections using aseptic techniques and precautions. The obtained i-PRF concentrate should be implanted directly into the deep layers of the dermis with the use of needle mesotherapy using the nappage or micro-deposit technique, and in places requiring special regeneration using the retrograde linear technique. To obtain optimal treatment effects, it is recommended to use 2-4 treatment tubes per treatment area.
I-PRF injections may cause redness, swelling, pain or slight bruising at the treatment site. Usually, these changes are mild and disappear after a few days. To obtain optimal correction effects and safe convalescence:
– do not apply makeup for up to 12 hours
avoid solarium and excessive sun exposure for up to 2 weeks after the procedure
– do not expose the correction site to extreme low and high temperatures
– apply ointments that seal blood vessels to the places where bruising occurred
– immediately report any disturbing changes to the specialist performing the procedure
DIVES MED i-PRF may only be used by doctors and medical personnel with postgraduate training in the techniques of using autologous blood products. Before use, familiarize yourself with the intended use and method of use of the set. Before starting the procedure, it is absolutely necessary to conduct a medical interview, rule out contraindications, obtain informed consent to perform the procedure and inform the patient about the possible results and possible side effects. During the implantation of the product, the procedure and the injection site should be fully aseptic. Do not inject intravenously or use for other purposes. Set for single use. Do not re-use and do not re-sterilize. Do not use after the expiration date. Incorrect or inconsistent with the manufacturer’s recommendations may lead to complications and side effects.
POSSIBLE SIDE EFFECTS:
DIVES MED i-PRF injections may lead to slight damage to blood vessels and the formation of hematomas and bruises. Immediately after the injection, swelling and redness, as well as short-term skin discoloration, may occur in the treatment area.
The DIVES MED i-PRF kit contains 4 single-use treatment tubes. Dispose of all used surgical instruments in a container for medical waste. After use, dispose of all components of the set according to instructions for the handling of potentially blood-contaminated materials. Use caution against unprotected needles and other contaminated surgical instruments. Do not put used needles back into the needle cap.
The contents of the blisters have been sterilized by radiation.
SHELF LIFE AND STORAGE:
Store the elements of the kit at the temperature of 2oC-28oC.
Do not use after the expiry date and in the case when the sterile blister with the tube is damaged or has been incorrectly stored.
Use the content of the blister for a single application and do not re-sterilize.