Sodium Citrate Sterile PRP (Platelet Rich Plasma) Blood Separation Kits
Reference No: OM-TM1-0001
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.
2 pcs 10 ml sodium citrate (1 ml) vacuum tube
1 x 5 ml luer lock injector
1 x 21 G 0.8*40 mm needle
1 x 18G 90 mm needle
1 piece 21G 0.8*38 mm needle
1 x Holder
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.
- Open the box.
- Open the sterile blister pack.
- Combine the holder and the blood collection needle.
- Apply the blood collection needle to the cleaned area where blood will be taken from the patient’s arm. (Venous)
- Place the PRP tube into the holder where the needle is attached. (Routine Phlebotomy)
- PRP Tube is vacuumed. When the tube receives enough blood, it stops on its own. (Do the same procedure for both tubes without removing the blood collection needle from the vein.)
- Centrifuge both tubes in the centrifuge device at 850 G for 8 minutes. Centrifuge godets must be compatible with tubes.
- Attach the 18G needle to the 5ml Luer-lok syringe.
- Collect PRP over the red blood (RBC) layer by inserting the 18G needle into the PRP tube. (Do not open the cap of the tubes unless Laminar Flow Conditions are met.)
- Carefully collect the 2ml PRP layer in a 5ml syringe.
- Apply the same protocol for the other PRP tube.
- There will be 4ml PRP in the syringe.
- Gently shake the syringe for 60 seconds to homogenize possible cell clumps in the plasma.
- Attach the needle to be applied to the 5ml Luer-Lock syringe.
- Apply to the patient by injection method.
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.
It must be used by a physician or physicians with sufficient experience in the use of the device.
PRP application is not recommended in the presence of any of the following conditions:
- Platelet Dysfunction Syndrome
- Critical Thrombocytopenia
- Hemodynamic instability
- Autoimmune diseases
- Acute chronic infections
- Chronic Liver Pathology
- Anticoagulation Therapy (ASA therapy, etc.)
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.
The expiration date on the product is valid for the shelf life of the product.
Explanation of Symbols on Box Label
|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|
|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|
Sterilized using ethylene oxide
Sterilized using irradiation
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|
Producer: KAIZEN INDUSTRY INDUSTRY AND FOREIGN TRADE LIMITED COMPANY
Bostanci District Gonen O.S.B. No. 3 Street No: 1 Gonen – BALIKESIR/TURKEY
Tel: +90 266 762 39 39 Email: email@example.com Website: http://www.kaizenendustri.com/
|Document No||Release Date||Revision No||Revision Date|