MEDICAL TREATMENT SET FOR OBTAINING AN AUTOLOGOUS FILLER
The use of the innovative DIVES MED Autologic Plasma Filler allows you to obtain the patient’s own blood, its separation into platelet-rich plasma (PRP), which after specialist thermal treatment is processed into a filling bio-gel. The effect of using the set is to obtain a highly concentrated Autologous Filler for reimplantation into the patient’s body. In addition to the filling effect, the plasma-derived growth factors contained in the filler intensively regenerate the skin, activate the synthesis of collagen and elastin and active angiogenesis. The treatment allows for natural and autologous smoothing of the skin, without changing the shape and features of the face. Its two-way, hybrid action allows you to achieve very fast rejuvenating effects that can last up to 3-6 months. The main advantage of the therapy is its autologous safety, with no risk of allergies, intolerance, or rejection.
The innovativeness of the obtained gel results from its highest safety profile, wide spectrum of application, minimal risk of complications and exceptionally easy and economical extraction procedure.
The kit includes 2 polycarbonate, sterile, vacuum tubes with a capacity of 9 ml, filled with the ACD anticoagulant solution (sodium citrate, citric acid, glucose), preventing premature clotting of the collected blood. Tubes enable a vacuum, completely closed blood collection system, which increases the safety of the procedure and prevents material contamination. The production of medical polycarbonate tubes maximizes the level of platelets (PLT) in the PRP concentrate and increases the effectiveness of the therapy.
Tubes are intended for reimplantation procedures and are marked with a medical certificate of group II B in vivo.
Additionally, the set includes a set of treatment instruments containing:
– butterfly needle with a tubing
– 21G 0.8x30mm system needle for vacuum blood collection
– PRP 20G 0.9x70mm blood collection needle
– luer-lock syringe with a capacity of 5 ml
– 2 luer-lock syringes with a capacity of 10 ml
– 6 luer-lock syringes with a capacity of 1 ml
– 6 injection needles 27G 0.4x13mm
– 2 injection needles 30G 0.3x13mm
– 2 injection needles 32G 0.23x4mm
– 25G 0.5x50mm cannula
– 6 luer-lock Combi Stopper plugs
– luer-lock connector
– three-way tap
HOW TO USE:
Step 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 test tube will begin to automatically fill with blood to the volume of about 9ml. After filling, disconnect the tube and repeat the step with the other tube. Turn the received test tubes upside down several times in order to mix the blood with the ACD 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 tubes opposite to the centrifuge. Centrifuge for 5 minutes at 1100g centrifugal force (RCF). Set the rotational speed according to the recommendations of the centrifuge manufacturer.
Step 3: Collection PPP and PRP
The centrifugal force will arrange the morphotic parts according to the gravitational weight and obtain 3 separate fractions. There will be red blood cells at the bottom of the test tube, platelets (PRP) above them, and platelet poor plasma (PPP) above them. Use a 20G 0.9x70mm needle and draw the top part of the plasma (PPP) directly into 1ml syringes. Collect no more than 3 ml of platelet poor plasma (PPP) from each test tube. Collect the platelet-rich plasma (PRP) into a separate 10ml syringe.
Stage 4: Thermal treatment
1ml syringes with PPP concentrate screw on the Combi Stopper cap and place in the bottle holder. Heat according to the manufacturer’s recommendations. During the thermal process, plasma proteins will coagulate to form an autologous bio-gel. The original density of the obtained gel depends on the used heating time and temperature. To proceed to the next step, cool the syringes to room temperature.
Step 5: Combining the obtained gel with platelet-rich plasma
Transfer the contents of 1 ml syringes using the 10 ml syringe adapter. Then connect the 10ml syringe with the obtained bio-gel to the 10ml syringe with the PRP-rich plasma obtained earlier using the three-way tap.
Mix the contents of both syringes until a uniform consistency is obtained. The obtained concentrate is the proper Autologous Filler.
Stage 6: Injection
Apply the obtained Autologous Filler into the tissues in accordance with the applicable implantation techniques. Before the injection, clean the treatment area with an antiseptic and let it dry. Use needles or cannulas with a diameter of 25G for the procedure. Appropriate sterile needles and a cannula are included in the package. Before the injection, it is recommended to perform aspiration to minimize the risk of injecting the preparation into the lumen of the blood vessel. Apply slowly using a technique appropriate to the treatment area.
Stage 7: Utilization
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.
– Pregnancy and lactation
– Active viral and bacterial infection
– Blood diseases
– Taking medications that impair blood clotting and NSAIDs
– Acute conditions in the course of autoimmune diseases
Autologous Filler 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 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 places where bruising occurred
– immediately report any disturbing changes to the specialist performing the procedure
DIVES MED Autologic Plasma Filler 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 purpose 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:
Autologous Filler 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. In extreme cases, implantation may lead to impaired circulation as a result of unintentional injection of the implant directly into a blood vessel or as a result of pressure on the vessels, and consequently a potential risk of ischemia or necrosis.
The DIVES MED Autologic Plasma Filler set contains a treatment set for single use. Discard 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 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 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 stored incorrectly. Use the content of the blister for a single application and do not re-sterilize.