N500 – INSTRUCTIONS FOR USE

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
• The Performance of The Device Intended by The Manufacturer
• Clinical Safety Information
• Residual Risk Information and Side Effect Information
• User Profile
• Procedure
• Storage, Shelf Life and Handling Information
• Precautions, Warnings, Measures to Be Taken and Limitations
• Possible Adverse Events
• Indications, Patient Profile and Possible Contraindicative Situations
• Symbols and Explanations

Name or Trade Name of The Medical Device

PRP SYRINGE
The product is a sterile, single use medical device.

Name and the Address of the Manufacturer

T-Biyoteknoloji Laboratuvar Estetik Medikal Kozmetik San. Tic. Ltd. Sti.
Tahtali Mh. Degirmen Yolu (460) Sk. No:10 16280 Nilufer / Bursa / Turkey
Phone: +90 224 246 8522
E-mail: info@ifuport.com

Product Content List

• 1 unit of 10ml PRP SYRINGE
• 1 unit of Luer-cap
• 1 unit of Luer-adaptor

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.

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 is very important for PRP treatments. Blood withdrawn from the patient is centrifuged to concentrate the PRP layer. Recommended G force for the concentration is 1500 G for 4 minutes. The blood separation system takes the advantage of centrifugation force effecting on the weight of the cells. The separation occurs during centrifugation when the denser blood components move due to a gravity force.

The PRP SYRINGE shall not be mixed after the centrifugation. 3-4ml of layer is discarded carefully to another syringe until the erythrocytes (Red Blood Cell layer).

The result is a convenient syringe system, collection of the whole blood and concentration of Platelet Rich Plasma. PRP SYRINGE reduces the risk of air contamination, eliminates the need of any other tubes or pipettes.

Clinical Safety Information

The safety and efficacy of this device has been proven by Risk Analysis Report and Clinical Evaluation Report, attached to the Technical Construction File of PRP SYRINGE.

Residual Risk and Side Effects Information

According to the risk assessment, risk management, risk report procedures of this device, it shows no residual risks. With respect to the requirements of Essential Requirements 6, the risk management report showed that there were no serious side effects and the performance of the product was verified by the clinical evaluation report.

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.

Procedure

Apply the following instructions to obtain Platelet Rich Plasma by using PRP SYRINGE.

• Open the box.
• Open the Sterile Blister Packaging.
• Attach a hypodermic needle or butterfly needle to PRP SYRINGE.
• Prepare the patient’s arm in order to draw blood (sanitize the skin).
• Apply the needle to sanitized part of the patient’s arm (venous).
• Prepare balancing weight for centrifugation balance.
• Start drawing the blood until 10ml indicated on the PRP SYRINGE (Phlebotomy).
• De-attach the needle from PRP SYRINGE and use the cap provided in the packaging to close PRP SYRINGE.
• De-attach the plunger as indicated on the body. And immediately move onto the centrifuge process.
• Attach the PRP SYRINGE into the buckets of a swing rotor centrifuging unit as the lid of PRP SYRINGE is on top.
• Adjust the parameters of centrifuging unit as 1500G for 4 minutes. And start the centrifuging process.
• After centrifugation, take the PRP SYRINGE inside from the bucket and do not shake or do not flip PRP SYRINGE upside down.
• Attach the plunger to the piston as indicated on the body.
• Open the lid of PRP SYRINGE. And attach the Luer-connector to the PRP SYRINGE while holding the PRP SYRINGE vertically.
• Attach the Luer-connector to another Luer-tip syringe.
• And press the plunger of PRP SYRINGE in order to transfer the prepared PRP layer from the PRP SYRINGE until reaching up to Red Blood Cell Layer.
• Do not transfer RBC Layer.
• PRP is ready to be injected.

Storage, Shelf Life and Handling Information

• PRP SYRINGE has been sterilized with Ethylene Oxide.
• Do not expose to direct sunlight.
• Store in a cool, dry place.
• Do not use if the inner sterile blister package is damaged or opened.
• Product shelf life is 5 years. Use by Date is indicated on the product label.
• Store at temperatures between 5°C and 30°C.

Precautions, Warnings, Measures to be Taken and Limitations

• Use proper safety precautions to guard against needle sticks.
• Follow manufacturer instructions when using centrifuge.
• Do not use sterile component of this kit if package is opened or damaged.
• 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.
• The safety and effectiveness of PRP treatment have not been established in children and pregnant women.
• Do not dispose of this product in the unsorted municipal waste stream.

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.
• Inflammatory reaction.

Indications, Patient Profile and Possible Contraindicative Situations

- Indications and Patient Profile Patient Profile

Platelet rich plasma is an autologous application technique therefore patient applications are inherently safe from infectious diseases such as HIV, Hepatitis, Creutzfeldt-Jakob disease.

PRP SYRINGE can be used safe and effectively on all patients. The safety and effectiveness of PRP treatment have not been established in children and pregnant women.

• Users of the device as a treatment of alopecia areata
• Users of the device as a treatment of Optic Disk Pit Maculopathy
• Users of the device as a treatment of joint pains (mostly knees with OA)
• Users of the device as a treatment of rotator cuff injuries
• Users of the device as a treatment of tennis elbow sufferings
• Users of the device as a treatment of Chronic Plantar Fasciitis
• Users of the device as a treatment of Scaphoid Fracture
• Users of the device as a treatment of Chronic Patellar Tendinopathy
• Users of the device as a treatment of Osgood–Schlatter Disease

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 etc.)
• Pregnancy (for cosmetic indications)
• Newborns

Symbols and Explanations (Product Label & IFU)

TF02.IFU.R12  |   Release Date: 25/06/2018  |   Revision Date: 18/08/2023