USER MANUAL KIT DESCRIPTION:
Medical device for the preparation of autologous P.R.P. (Platelet-rich plasma).
This is a medical device for the preparation of Platelet-Rich Plasma (PRP) from collected patient blood, which includes:
Case No. 1: These are pre-labeled ACD tubes with colored cap containing ~1 ml of anticoagulant (ACD); each labeled tube, e.g., 9ml capacity, has a pre-calibrated vacuum for ~9ml blood draw.
There are one or two tubes in the case, in each of which there is a separating gel based on an inert polymer and an anticoagulant (named for ease of understanding, type 1 tube, which is necessary for the separation between platelet-enriched serum (injectable fluid enriched with growth factors) and the blood haem concentrate (clot) that is determined after centrifugation.
INTENDED USE: Acceleration of tissue healing.
DPRP PRP is a kit designed to separate and prepare plasma easily and efficiently with higher platelet concentration in an optimal amount. The DPRP PRP Regenerative Therapy Kit enables the preparation of platelet-rich plasma (PRP) by centrifugation of autologous blood.
Its use is indicated for the treatment of skin rejuvenation, acne/scars, and alopecia/hair loss conditions. Benefits of using PLASMOGEL PRP-GEL include induction of cell differentiation, formation of Extracellular Matrix, and recruitment of other cells to the site of injury.
The method based on this preparation is called “BUFFY COAT” with a glass tube, which differs from the “EMPTY TUBE” (simple vacuum blood collection tube), which does not obtain a concentrate but a serum; it cannot separate the blood with high precision and obtain a high concentration of PRP and does not allow only the intermediate layer (PRP) to be extracted. In addition, the plastic of the tubes contains micronized silicone, which can also generate platelet activation. All this results in a platelet-free serum after the centrifugation process that cannot be used for PRP.
In addition to centrifugation, PRP can also be obtained by:
VERTICAL CELLULAR PRECIPITATION: In case cell separation is to be carried out for obtaining P.R.P. by cell precipitation of the different specific weights (VERTICAL GRAVITATIONAL DECANATION), place the tube vertically on a tube rack and wait for cell separation by natural gravitational action from 2 to 3 hours. The medical device in question is not manufactured from plastic that contains micronized silicone.
Platelet-rich plasma (PRP), also referred to as autologous platelet gel (Autologous Platelet Gel), growth factor-rich plasma (PRGF) or platelet concentrate (PC), is essentially an increase in the concentration of autologous platelets suspended in a small amount of plasma after centrifugation of the patient’s own blood.
00068-Dermoaroma DPG PRP IFU.indd 1
The medical device should be used only by properly trained medical or nursing staff under medical responsibility.
COMPOSITION OF THE PLASMOGEL PRP-GEL KIT
The PRP kit contains all the necessary accessories for preparing platelet-rich plasma.
All accessories are disposable, sterile and comply with European Union regulations for a high standard of production control for safety. PRP tubes (sterile, pyrogen-free): 1 tube x 9 ml Each 9 ml PRP tube contains:
– Separator gel.
– Anticoagulant (Sodium Citrate 3-4%).
DESCRIPTION OF USE AND RISK CLASS
Medical devices for concentrate preparation and platelet gels belong to class IIA medical devices according to Rule 3 point 1.3 of Annex IX of Directive 2007/47/EC.