T2001 - INSTRUCTIONS FOR USE

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
Procedure
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

PRX TUBES
The product is a sterile, single use medical device.

The Name and The Address of The Manufacturer

T-Biyoteknoloji Laboratuvar Estetik Medikal Kozmetik San. Tic. Ltd. Şti.
Tahtalı Mah. Değirmen Yolu (460) Sk. No:10 Nilüfer / Bursa /Turkey
Phone: +90 224 246 8522
E-mail: info@tlab.com.tr
Manufacturer ID No (SRN): TR-MF-000016403

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
Hypofibrinogenaemia
Hemodynamic instability
Auto-immune diseases
Malignancy
Sepsis
Acute Chronic infections
Chronic Liver Pathology
Anti-coagulation Therapy (ASA therapy )
Pregnancy (for cosmetic indications)
Newborns

Patient Profile

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 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.

The result is a convenient system, collection of the whole blood and concentration of platelet-rich plasma. PRX TUBE is interior sterilized using irradiation. PRX TUBE reduces the risk of contamination.

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.

User Profile

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.
Centrifuge
- Swing out rotor centrifuge is recommended to be used.
- As stated in the Procedure section, centrifuge should be set to 1500 G 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 minimum capacity of 5 ml and be a locked model.

Procedure

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 Centrifuge buckets shall be compatible with 16 X 100 mm tubes.
Attach a long needle to 5 ml Luer-lok
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
Carefully collect 4ml of concentrated plasma layer.
Inject the platelet concentrate to the patient as soon as possible.

Storage, Shelf 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.
Temperature limit: 5-30°C

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 It is intended to be used only to collect the PRP /injectable PRF layer from PRX TUBES.