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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
- The Performance of The Device Intended by The Manufacturer
- Clinical Safety Information
- Residual Risk Information and Side Effect Information
- User Profile
- 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
The product is a sterile, single use medical device.
Name and the Address of the Manufacturer
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 Blood withdrawn from the patient is centrifuged to concentrate the PRP layer.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.
This product should be used by physicians or physician-directed allied health care professionals with adequate training in the use of the device.
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, Product 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.
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 fine& deep wrinkles
- Users of the device as a treatment of soft tissue stimulation
- Users of the device as a treatment of correction of hypertrophic & atrophic scar corrections
- Users of the device as a treatment of face & neck revitalization
- 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
- And several orthopedics similar failures.
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)
Symbols and Explanations (Product Label & IFU)
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 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
Indicates a medical device that should not be used if the package has been damaged or opened.
Federal law restricts the device to sale by on the order of a doctor
Keep Away from Sunlight
Indicates a medical device that needs protection from light sources.
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 Instructions for Use
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.
TF02.IFU.R08 | Release Date: 08/10/2018 | Revision Date: 13/09/2019