System with separating gel is a specialized program for the acquisition and reimplantation of Platelet Rich Plasma.
DIVES MED PRP is a specialized system for the acquisition and reimplantation of Platelet Rich Plasma for the purpose of bio stimulating skin cells. The use of a specialized DIVES MED PRP kit allows for the production of platelet-rich plasma (PRP), i.e., an autologous blood derivative containing an increased number of platelets, diluted in a small volume of plasma. PRP concentrate is obtained by taking blood directly from the patient and its subsequent centrifugation. The centrifugation process separates individual blood cells according to their weight and separates the PLT fraction (platelets) and plasma. As a result, we obtain a highly concentrated PRP concentrate with remarkably regenerating and rejuvenating properties, which we reimplant 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. DIVES MED PRP platelet-rich plasma is relatively widely used in maxillofacial surgery, orthopaedics, as well as in sports and aesthetic medicine.
The kit includes 2 polycarbonate, sterile, vacuum tubes with a capacity of 8 ml, filled with an anticoagulant (sodium citrate) and a separating gel. Tubes allow a vacuum, completely closed blood collection system, which increases the safety of the procedure and prevents material contamination. The production of test tubes from medical polycarbonate results in the maximization of the level of platelets (PLT) in the PRP concentrate and an increase in the effectiveness of the therapy. Each of the tubes is packed in a separate blister, which allows the set to be divided into 2 independent treatments. 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 equipment sets containing:
– butterfly needle with a tubing
– system needle for vacuum blood collection 21G 0.8x30mm
– collection needle PRP 20G 0.9x70mm
– a luer-lock syringe with a capacity of 3 ml
– luer-lock syringe with a capacity of 5 ml
– 2 injection needles 30G 0.3x13mm
– 2 injection needles 32G 0.23x4mm
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 8 ml. After filling, disconnect the tube and, if necessary, attach another. The obtained test tubes are turned upside down several times in order to mix the blood with the anticoagulant solution. 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 tube in a centrifuge. On the opposite side, sweep a counterweight filled with water or another blood tube to balance the device. Centrifuge for 5 minutes at 1200 g centrifugal force (RCF). Set the rotational speed according to the recommendations of the manufacturers of the centrifuge.
Stage 3: PRP Collection
The centrifugal force will arrange the morphotic parts according to the gravitational weight and obtain 4 fractions. There will be red blood cells at the bottom of the tube, a separating gel above them, platelets (PLT) on top, and platelet poor plasma (PPP) on top. Turn the test tube upside down several times, which will allow the PLT plate concentrate to detach from the separating gel. Mixing the PLT phase with the PPP phase will result in platelet-rich plasma (PRP). Use a 20G 0.9x70mm needle and draw the resulting solution directly into the syringe. The contained separating gel is not intended for injection. From the separation of 1 tube, you will receive a total of about 4 ml of platelet-rich plasma (PRP).
Stage 4: Injection
The resulting PRP solution is immediately injected into the tissues. The administration of PRP within 30 minutes from the moment of collection ensures full biological activity of the solution. It is possible to use some or all of the obtained preparation.
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. Use caution from unprotected needles and other contaminated treatment instruments.
DOSAGE AND INJECTION METHOD:
Joint space injections should be performed with medical imaging and with 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 1 treatment tube per joint.
Perform intradermal injections using aseptic techniques and precautions. The obtained PRP 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 1-2 tubes per treatment area.
The external use of PRP plate concentrate is possible in conjunction with other aesthetic medicine procedures (e.g., microneedle mesotherapy, fractional laser). Apply the obtained product epidermally after damaging the skin.
Injections of PRP concentrate 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 sunbeds 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 place where the bruising occurred
– immediately report any disturbing changes to the specialist performing the procedure
DIVES MED PRP may only be used by physicians and medical personnel with specialized training in the techniques of using autologous blood products. Before use, familiarize yourself with the purpose and method of use of the set. Before starting the procedure, it is absolutely necessary to conduct a medical history, rule out contraindications, obtain informed consent to perform the procedure and inform the patient about 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. The contained separating gel is not intended for injection and should not be administered into tissues. Single-use test tube and instruments. 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 PRP injections may lead to slight damage to blood vessels and the formation of hematomas and bruises. Immediately after injection, the treatment area may experience swelling and redness, as well as a short-term secondary inflammatory reaction. Isolated allergic reactions have been reported in the case of unwanted injection of a separating gel.
The DIVES MED PRP kit contains 2 single-use treatment sets. Dispose of all used surgical instruments in a container for medical waste. After use, dispose of all parts of the set according to instructions for the handling of potentially blood-contaminated materials. Use caution from unguarded 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 at 2oC-28oC, away from sunlight and heat sources. Do not use the product after the expiry date and if the blister is damaged or has been incorrectly stored. Use the content of the blister and the treatment instruments for a single application and do not re-sterilize.