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Table of Contents:
- The Name or Trade Name of The Medical Device
- The Name and The Address of The Manufacturer
- Product Content List
- Intended Use of The Product
- Possible Contraindicative Situations
- Patient Profile
- The Performance of The Device Intended by The Manufacturer
- Possible Adverse Events
- User Profile
- Medical Devices To Be Used With The Device
- Storage, Shelf Life and Handling Information
- Precautions, Warnings, Measures to Be Taken and Limitations
- Symbols and Explanations
The Name or Trade Name of The Medical Device
The product is a sterile, single use medical device.
The Name and The Address of The Manufacturer
Product Content List
- 2 units of PRP Tube(s)
Intended Use of The Product
The device is designed to be used for the safe and rapid preparation of autologous platelet-rich-plasma (PRP) from a small sample of blood at the patient’s point of care. The PRP is prepared prior to application to a local area of soft tissue or hard tissue (including bone) site as deemed necessary by the clinical use requirements. And its intended use is for the application of PRP in order to achieve the stimulation of soft tissue and hard tissue (including bone) and acceleration of soft tissue and hard tissue (including bone) healing.
Possible Contraindicative Situations
- Platelet Dysfunction Syndrome
- Critical Thrombocytopaenia
- Hemodynamic instability
- Auto-immune diseases
- Acute Chronic infections
- Chronic Liver Pathology
- Anti-coagulation Therapy (ASA therapy etc.)
- Pregnancy (for cosmetic indications)
Platelet rich plasma is an autologous application technique and it is used on the same patient. Due to this information, platelet-rich plasma applications are inherently safe from infectious diseases such as HIV, Hepatitis, Creutzfeldt-Jakob disease.
As an autologous technique; however, Platelet-Rich Plasma can be used safe and effectively to all patients, there may have a need for further studies on pregnant and newborns.
The Performance of The Device Intended by The Manufacturer
PRP (Platelet Rich Plasma) is used for many years in the frame of regenerative medicine, which allows the cellular healing on bone and soft tissue recovery. Bone and soft tissue healing is occurred by the platelet concentration and re-injection locally to the related part of the body.
Concentration of platelets with buffy coat layer is very important for PRP treatments. Currently accepted technique for avoiding coagulation of the whole blood, referred to Sodium Citrate. The procedure uses anticoagulated blood, collected by routine phlebotomy. Buffered Citrate Solution blocks the coagulation by mixing gently the whole blood together with 3,20% concentrated 0,1M of Sodium Citrate. This preparation is then centrifuged to concentrate the PRP layer. Recommended G force for the concentration is 830 G. The blood separation system takes the advantage of centrifugational force effecting on the weight of the cells. The separation occurs during centrifugation when the denser blood components move due to a gravity force.
PRP TUBES shall not be mixed after the centrifugation. 2ml of layer is harvested carefully above the erythrocytes (Red Blood Cell layer). The result is a convenient system, collection of the whole blood and concentration of Platelet Rich Plasma. PRP Tubes are interior sterilized using irradiation. PRP TUBES reduces the risk of air contamination, eliminates the need of any other tubes or pipettes.
Possible Adverse Events
- Damage to blood vessels, hematoma / delayed wound healing and/or infection associated with blood draw.
- Temporary or permanent nerve damage that may result in pain or numbness.
- Early or late postoperative infection.
This product should be used by physicians or physician-directed allied health care professionals with adequate training in the use of the device.
Medical Devices to Be Used with The Device
- Blood Collection Needle / Phlebotomy Set / Butterfly Set
- Phlebotomy set / butterfly set / blood collection needle shall not be thinner than 21G.
- As stated in the How to use section, centrifuge should be set to 830G and 8 minutes.
- PRP TUBES have dimensions of 16X100 mm. Centrifuge bucket shall be selected accordingly.
- Place the tubes in the centrifuge so that they are of equal weight.
- Avoid using unbalanced centrifugal devices.
- Long Needle and Syringe
- Long needle shall be 88mm-90mm 18G-19G.
- Long needle used to collect PRP layer from the tube is not intended to be used for the injection procedure.
- Syringe used to collect the PRP layer shall have a a minimum capacity of 4ml and be a locked model.
Apply the following instructions to obtain Platelet Rich Plasma by using PRP TUBES:
- Open the box.
- Open the blister package.
- Apply the blood collection device to sanitized part of the patient’s arm. (Venous)
- Attach PRP TUBES to blood collection device. PRP TUBES is a vacuumed tube. The tube collects enough amount of blood and stops itself. Apply both tubes, without removing the needle from the vessel.
- Centrifuge both tubes in a centrifuging device at 830 G for 8 minutes. Buckets shall be compatible with 16 X 100 mm PRP TUBES.
- Attach a long needle to 5ml Luer-lok Syringe.
- Collect the PRP above the RBC layer by inserting a long needle into PRP TUBES without opening the lid unless performed under laminar flow conditions.
- Carefully collect 2ml of PRP Layer.
- Apply the same protocol for the second tube of PRP TUBES.
- Apply the injection method to the patient.
Storage, Product Life and Handling Information
- Do not expose to direct sunlight.
- Do not use if the inner blister package is damaged or opened.
- Shelf life (Product Lifecycle) is the expiration date on the label.
Precautions, Warnings, Measures to Be Taken and Limitations
- Use proper safety precautions to guard against needle sticks.
- Follow manufacturer’s instructions when using centrifuge.
- Do not use if the inner blister package is damaged or opened.
- Do not open the lids of the tubes.
- Single use device, do not reuse.
- The user should be thoroughly familiar with the equipment and the surgical procedure prior to using this device.
- The patient should be made aware of general risks associated with treatment and possible adverse effects.
- Do not dispose of this product in the unsorted municipal waste stream.
- Long Needle is not intended to be used on patients. It is intended to be used only to collect PRP layer from PRP TUBES.
Symbols and Explanations
European Medical Devices Directive 93/42/EEC of 14 June 1993
Notified Body: Szutest (2195)
Indicates manufacturer declaration that the product complies with the essential requirements of the relevant European health, safety and environmental protection legislation.
Indicates the medical device manufacturer, as defined in EU Directive 93/42/EEC.
Indicates the manufacturer's catalog number so that the medical device can be identified NOTE: Synonyms for "catalogue number" are "reference number" and "reorder number"
Indicates the manufacturer's batch code so that the batch or lot can be identified
Use by date
Indicates the date after which the medical device is not to be used.
Sterilized Using Irradiation
Indicates a medical device that has been sterilized using irradiation.
Do Not Re-sterilize
Indicates a medical device that is not to be re-sterilized.
Do Not Use if Package is Damaged
Keep Away from Sunlight
Indicates a medical device that needs to be protected from moisture.
Indicates the temperature limits to which the medical device can be safely exposed.
Do Not Reuse
Indicates a medical device that is intended for one use, or for use on a single patient during a single procedure.
Consult Instructions for Use
Indicates the need for the user to consult the instructions for use.
Electronic Instruction Manual
Indicates on product packaging that relevant information for use of the product is available in electronic form in addition to, printed paper form.
Indicates the need for the user to consult the instructions for use for important cautionary information such as warnings and precautions that cannot, for a variety of reasons, be presented on the medical device itself.
TF03.02 IFU.R04 | Release Date: 18/08/2016 | Revision Date: 15/04/2020