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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
- 1 unit of PRX Tube
Intended Use of The Product
PRX TUBES is designed to be used for the safe and rapid preparation of autologous platelet-rich plasma/ injectable platelet-rich fibrin from a small sample of blood without the addition of anticoagulant at the patient’s point of care. The platelet-rich plasma/ injectable platelet-rich fibrin 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 autologous platelet concentrates 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)
Non-anticoagulated platelet-rich plasma is an autologous application technique and it is used on the same patient. Due to this information, these applications are inherently safe from infectious diseases such as HIV, Hepatitis, Creutzfeldt-Jakob disease.
As an autologous technique; non-anticoagulated platelet-rich plasma can be used safely and effectively on all patients, there may have a need for further studies on pregnant and newborns.
The Performance of The Device Intended by The Manufacturer
Platelet concentrations have been used for many years in the frame of regenerative medicine, which allows the cellular healing on bone and soft tissue recovery.
Non-anticoagulated platelet-rich plasma is considered a second-generation platelet concentration. PRX TUBES is a vacuumed blood collection tube without the addition of anticoagulants. The main variable in optimizing the platelet concentrate is the following centrifuge protocol patented by T-Biyoteknoloji. The time gap between the blood collection and its transfer to centrifuge should be kept to a minimum.
When PRX TUBES is used to obtain platelet concentration the method of preparation of non-anticoagulated platelet-rich plasma yields to a platelet concentration which is also known as injectable platelet-rich fibrin.
The procedure uses blood collected by routine phlebotomy into a vacuumed blood collection tube.
The result is a convenient system, collection of the whole blood and concentration of platelet-rich plasma. PRX TUBES is interior sterilized using irradiation as well as terminally EO sterilized. PRX TUBES reduces the risk of contamination.
The autologous platelet-rich plasma that was obtained without the addition of anticoagulants should be processed and injected back to the patient shortly after. T-Biyoteknoloji recommends the user to check the viscosity of the non-anticoagulated plasma concentration before injection. As the concentration is obtained without anticoagulants, the concentration may clot and become into a gel form, therefore, be non-injectable.
Possible Adverse Events
- Damage to blood vessels, hematoma / delayed wound healing and/or infection associated with a 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.
- Swing out rotor centrifuge is recommended to be used.
- As stated in the How to use section, centrifuge should be set to 1500G and 4 minutes.
- PRX TUBES has a dimension of 16X100 mm. Centrifuge bucket shall be selected accordingly.
- Place another tube (blank) of the same weight as PRX tube in the centrifuge to balance.
- Avoid using unbalanced centrifugal devices.
- Long Needle and Syringe
- Long needle shall be 88mm-90mm 18G-19G.
- Long needle used to collect platelet concentration from the tube, is not intended to be used for the injection procedure.
- Syringe used to collect the platelet concentration shall have a a minimum capacity of 5ml and be a locked model.
Apply the following instructions to obtain non-anticoagulated platelet rich plasma by using PRX TUBES:
- Open the box and package.
- Apply the blood collection device to sanitized part of the patient’s arm (venous).
- Attach PRX TUBES to blood collection needle. PRX TUBES is a vacuumed tube. The tube collects enough amount of blood and stops itself.
- Centrifuge PRX tube(s) immediately in a centrifuging device at 1500 G for 4 minutes. Centrifuge buckets shall be compatible with 16 X 100 mm tubes.
- Attach a long needle to 5ml Luer-lok Syringe.
- Collect the PRP/ injectable PRF above the RBC layer by inserting a long needle into PRX TUBES without opening the lid unless performed under laminar flow conditions.
- Carefully collect 4ml of concentrated plasma layer.
- Inject the platelet concentrate to the patient as soon as possible.
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.
- PRX TUBES is a single tube, use a blank tube to balance centrifuge.
- Do not use if the inner blister package is damaged or opened.
- PRX TUBES are terminally sterilized with ethylene oxide (EO), can be used in controlled environments.
- Do not open the lids of the tubes.
- This device does not contain an anticoagulant. Check for the viscosity of the platelet concentration to ensure it is in an injectable state before injection.
- A 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 the 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 the PRP /injectable PRF layer from PRX TUBES.
Symbols and Explanations
European Medical Devices Directive 93/42/EEC of 14 June 1993
Notified Body: Notice (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.
Sterilized Using Ethylene Oxide
Indicates a medical device that has been sterilized using ethylene oxide.
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.
TF04.01 IFU.R02 | Release Date: 21/10/2019 | Revision Date: 23/07/2020