DIVES MED - I-PRF Multifil Solution

DIVES MED i-PRF is a specialized system for obtaining and reimplanting Injectable Plasma Rich Fibrin for the purpose of biostimulation of skin cells.

The use of a specialized set dives MED i-PRF allows to obtain platelet-rich fibrin, i.e. an autologous tissue stimulator containing an increased number of platelets and mesenchymal stem cells. i-PRF concentrate is obtained by taking blood directly from the patient and its subsequent centrifugation. The spinning process results in the formation of a three-dimensional spatial structure, composed of platelets and fibrin fibers. The obtained i-PRF concentrate with exceptional regenerating and rejuvenating potential is re-implanted into the patient's body. This triggers a number 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, devoid of the risk of allergies, intolerance or rejection. Platelet-rich fibrin DIVES MED i-PRF is relatively widely used in maxillofacial surgery, orthopedics, as well as in sports and aesthetic medicine.

INDICATE:

• flaccid and damaged skin, requiring strong revitalization

• numerous wrinkles and progressive skin aging

• dry, gray and tired skin

• sensitive and allergic skin, requiring intensive reconstruction

• acne and post-traumatic scars

• stretch marks and sagging skin

COMPOSITION OF THE SET:

The set includes 4 sterile, apirogenic, polycarbonate test tubes with a capacity of 10ml. The test tubes enable a vacuum, fully enclosed blood collection system, which increases surgical safety and prevents contamination of the material. Each of the test tubes is packed in a separate blister, allowing you to divide the set into independent treatments. Making medical polycarbonate test tubes results in maximizing the level of platelets (PLT) in the PRP concentrate and increasing the effectiveness of the therapy. Test tubes are intended for reimplantation procedures and are marked with a group II B medical certificate.

In addition, the set includes 2 disposable sets of treatment instruments containing:

– butterfly needle with hose

– system needle for vacuum blood collection 21G 0.8x30mm

– holder holder

– i-PRF download needle 20G/ 0,9x70mm

– luer-lock syringe with a capacity of 1ml

– luer-lock syringe with a capacity of 3ml

– 2 injection needles 30G/0.3x13mm

– 2 injection needles 30G/0.3x4mm

DIRECTIONS FOR USE:

Step 1: 

Whole blood collection

Before starting the blood draw, disinfect the skin. Open a set of treatment instruments and a blister with a test tube. Make a venous puncture with the included accessories for phlebotomy, and then connect a test tube with a holder. The test tube will start to fill with blood on its own, up to a volume of about 9ml. After filling, disconnect the test tube and, if necessary, connect another one. Turn the resulting test tubes upside down several times to mix the blood with the ACD solution. Place contaminated collection instruments in a medical waste container and dispose of them in accordance with procedures for handling blood-contaminated materials.

Step 2: 

Spin

Place the resulting test tubes evenly, opposite in the centrifuge. Swing for 3 minutes with a centrifugal force (RCF) of 50g. Set the rotational speed according to the recommendations of the centrifuge manufacturer.

Step 3: 

Download i-PRF

The action of centrifugal force will result in the arrangement of morphotic parts according to gravitational weight and obtain 2 fractions. At the bottom of the test tube there will be red blood cells, and at the top there will be platelet-rich fibrin (i-PRF). Use a 20G 0.9x70mm needle and download fibrin directly into the syringe. From the separation of 1 test tube you will get a total of about 0.5-0.7ml of platelet-rich fibrin (i-PRF).

Step 4:

Injection

The resulting i-PRF concentrate is immediately administered into the tissues. Administration of i-PRF up to 3 minutes after collection ensures full biological activity of the solution. After this time, fibrin solidifies and becomes useless and impossible for further reimplantation.

Step 5: 

Disposal

After use, dispose of all elements of the treatment set as recommended for handling potentially contaminated materials. Be careful against unprotected needles and other contaminated treatment instruments.

DOSAGE AND METHOD OF INJECTION:

Intra-articular injections:

Injections into the articular space should be performed with medical imaging and the same precautions as for any other intraarticular injections. Immediately after the injection, the patient should refrain from activity that burdens the joints. Within 48 hours of the procedure, intensive physical activity should be limited. In order to obtain optimal treatment effects, it is recommended to use 2 treatment tubes per 1 joint.

Intradermal injections:

Intradermal injections should be performed in compliance with the principles of asepsis and precautions.

The obtained i-PRF concentrate should be implanted directly into the deep layers of the dermis using needle mesotherapy using the nappage or micro-deposit technique, and in places requiring special regeneration using the retrograde-linear technique. In order to obtain optimal treatment effects, it is recommended to use 2-4 treatment tubes per 1 treatment area.

Epidermal application:

The external use of PRP platelet concentrate is possible in combination with other aesthetic medicine procedures (e.g. microneedle mesotherapy, fractional laser). The resulting product should be applied epidermal after prior damage to the skin.

PERIOPERATIVE RECOMMENDATIONS:

i-PRF injections can cause redness, swelling, pain or slight bruising at the treatment site. Usually, these changes are mild and disappear after a few days. To achieve optimal correction effects and safe convalescence:

– do not apply makeup for up to 12 hours

– avoid solarium and excessive sun exposure up to 2 weeks after the treatment

– do not expose the correction site to extreme low and high temperatures

– apply ointments that seal blood vessels to places where bruising has occurred

– report any disturbing changes immediately to the specialist performing the procedure.

PRECAUTIONS:

DIVES Med. i-PRF can only be used by doctors and medical staff with postgraduate training in techniques for using autologous blood preparations. Before use, familiarize yourself with the purpose and method of using the kit. Before proceeding with the procedure, it is imperative to conduct a medical history, exclude 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, full aseptics of the procedure and injection site should be maintained. Do not inject intravenously or use as intended. Set for single use. Do not reuse or re-sterilize. Do not use after the expiration date. Incorrect or inconsistent with the manufacturer's recommendations use of the product can lead to complications and side effects.

POSSIBLE SIDE EFFECTS:

DIVES Med i-PRF injections can lead to slight damage to blood vessels and the formation of hematomas and bruises. Immediately after the injection, swelling and redness may occur in the treatment area, as well as short-term skin discoloration.

DISPOSAL:

Zestaw DIVES Med. i-PRF contains 4 treatment tubes for single use. Dispose of all used treatment instruments in a medical waste container. After use, dispose of all elements of the set in accordance with the recommendations for handling potentially contaminated materials. Be careful against unprotected needles and other contaminated treatment instruments. Do not place used needles back in the casing.

STERILISATION:

The contents of the blisters were sterilized with radiation radiation.

SHELF LIFE AND METHOD OF STORAGE:

Store the components of the set at a temperature of 2oC-28 oC.

Do not use after the expiry date and in the event that the sterile blister with the test tube is damaged or has been stored incorrectly.

Use the contents of the blister for a one-time application and do not re-sterilize.

CONTRAINDICATIONS:

• pregnancy and lactation

• active viral and bacterial infection

• blood diseases

• taking drugs that impair blood clotting and NSAIDs

• cancer

• acute conditions in the course of autoimmune diseases

The product can only be used  by professionals.

By making a purchase, you declare that you are a doctor or cosmetologist trained in aesthetic medicine.