OM-L1-0006 INSTRUCTIONS FOR USE

LIPOCUBE

Sodium Citrate Sterile PRP (Platelet Rich Plasma) Blood Separation Kits

Reference No: OM-L1-0006

PRODUCT AND INTENDED USE

Blood Separation Kits are products used to separate the patient’s own blood components according to their density using a centrifuge device. Thanks to the anticoagulant (sodium citrate 3.13%) in the tube content, the blood sample taken allows to obtain better quality PRP without clotting. PRP can be applied locally to soft and hard tissues in the clinical direction, allowing stimulation of tissues with PRP and faster healing of damaged tissues.

Product Content:

6 pcs 10 ml sodium citrate (1 ml) vacuum tube

PRODUCT PERFORMANCE AND CLINICAL INFORMATION

PRP treatment is an autologous treatment in which platelet-rich plasma is re-injected into the patient to heal bone and soft tissues. In this process, the accepted method according to the literature is the use of anticoagulant (sodium citrate) to prevent the blood taken from the patient from clotting. Anticoagulation is the process of mixing sodium citrate with the blood taken from the patient. The blood in the tube is separated using a centrifuge and the PRP layer is removed by the user. Clinical Evaluation Reports and Risk Analysis Reports indicate that the product is clinically effective and safe.

WARNINGS and PRECAUTIONS

The kits are specific to each patient and are for single use only.
For medical applications. It is not used for other purposes.
It should only be used by medically licensed physicians.
Expired products should not be used.
Do not use opened or damaged products.
Calibration of the centrifuge device to be used must be done. If a fixed-angle centrifuge is to be used, a centrifuge with a minimum opening of 45 degrees is used.
PPP should be used immediately after PRP has been separated.
Consideration should be given to the amount of sample, in case of vacuum loss.
The patient should be informed about the risks and possible side effects of the treatment.
Patients taking anti-inflammatory drugs and blood thinners should or should not undergo PRP treatment with the recommendation of a physician. (About medication use before and after PRP treatment)
The doctor’s recommendations for the day, before and after the treatment should be taken into consideration.

USAGE AND INDICATIONS

PRP therapy can be used in various medical applications such as dermatology, physical therapy, urology, gynecology, ophthalmology, various surgical branches (orthopedics, plastics, dentistry and jaw, heart and vascular) and hair transplantation applications.

PATIENT PROFILE

PRP is an autologous treatment technique that can be applied to people approved by the physician and under physician control. The fact that the treatment is autologous prevents contagion by preventing various infectious diseases and provides a safe application.

USER PROFILE

It must be used by a physician or physicians with sufficient experience in the use of the device.

CONTRAINDICATIONS:

PRP application is not recommended in the presence of any of the following conditions:

Platelet Dysfunction Syndrome
Critical Thrombocytopenia
Hypofibrinogenemia
Hemodynamic instability
Autoimmune diseases
Malignancy
Sepsis
Acute chronic infections
Chronic Liver Pathology
Anticoagulation Therapy (ASA therapy, etc.)
Pregnancy
Newborns

RISKS AND SIDE EFFECTS

According to the risk assessment, management and analysis reports carried out during the product production phase, temporary pain in the application area, temporary bruising or edema may occur in skin applications. For this reason, various damages and/or infections may occur if it is applied incorrectly by non-specialized person or persons and sterility conditions are not followed.

SHELF LIFE:

The expiration date on the product is valid for the shelf life of the product.

Explanation of Symbols on Box Label

NO	SYMBOL	DESCRIPTION	NO	SYMBOL	DESCRIPTION
1		Date of manufacture	13		Do not use if package is damaged and consult instructions for use
2		Use-by date	14		Keep away from sunlight
3		Batch code	15		Keep dry
4		Catalogue number	16		Temperature limit
5		Importer	17		Biological risks
6		Distributor	18		Do not re-use
7		Model number	19		Consult instructions for use or consult electronic instructions for use
8		Country of manufacture	20		Caution
9		Sterilized using ethylene oxide	21		Medical device
10		Sterilized using irradiation	22		Unique device identifier (01) UDI-DI Code, (10) Lot Number, (11) Production Date, (17) Expiration Date
11		Single sterile barrier system	23		CE Symbol of the SZUTEST Notified Body
12		Do not resterilize