T1000 - 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
Intended Patient Population
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
Patient Profile and Possible Contraindicative Situations
Symbols and Explanations

The Name or Trade Name of the Medical Device

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

The Name and the Address of the Manufacturer

T-Biyoteknoloji Laboratuvar Estetik Medikal Kozmetik San. Tic. Ltd. Şti.
Tahtalı Mh. Değirmen Yolu (460) Sk. No:10 16280 Nilüfer / Bursa / Turkey

Manufacturer ID No (SRN): TR-MF-000016403
Phone: +90 224 246 8522
E-mail: info@tlab.com.tr

Product Content List

2 units of PRP Tube(s)
1 unit of Re-suspension Tube
1 unit of Long Needle
1 unit of Holder
1 unit of 1ml Injector
1 unit of 5ml Injector
1 unit of 30G needle
1 unit of 21G needle
1 unit of Blood Collection Needle

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.

Intended patient population:

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

This application can be used safely and effectively on all patients but 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 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

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.

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. The prepared material is then centrifuged to obtain PRP. The recommended G Force for concentration is given in the "Procedure" section according to the centrifuge rotor. 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 Tube shall not be mixed after the centrifugation. According to the centrifuge rotor used and the desired protocol, PRP is harvested carefully above the erythrocytes (Red Blood Cell layer). The collected PRP is moved to Re-suspension tube for re-suspension process.

The result is a convenient tube system, collection of the whole blood and concentration of Platelet Rich Plasma. PRP Tubes included in PRP KIT are interior sterilized using irradiation. PRP KIT 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 File of PRP Kit.

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 KIT:

Open the box.
Open the sterile blister package.
Attach Blood Collection Needle to Holder.
Apply the Blood Collection Needle to sanitized part of the patient’s arm. (Venous)
Attach PRP Tube inside the holder to Blood Collection Needle. (Routine Phlebotomy)
PRP Tube is a vacuumed tube. The tube collects enough amount of blood and stops itself. (Apply both tubes, without removing the Blood Collection Needle from the vessel.)
Spin both tubes in a centrifuge according to the below-mentioned table. (The physician must choose the procedure).

	Fixed Rotor Centrifuge	Swing Rotor Centrifuge
Pure PRP Protocol	500 RCF & 3 Minutes	1150 RCF & 4 Minutes
Amber PRP Protocol	500 RCF & 6 Minutes	1150 RCF & 8 Minutes
500 RCF=2000 RPM, 1150 RCF=2900 RPM
AMBER PRP: LR-PRP (Leukocyte Rich PRP) PURE PRP: LP-PRP (Leukocyte Poor PRP)

Buckets shall be compatible for PRP Tubes (16 X 100 mm tube size).
Attach Long Needle to 5ml Luer-lok Syringe.
Collect the PRP by sticking the Long needle into the PRP Tube above the RBC Layer (Do not open the Lid of the tube unless it is not performed under Laminar Flow Conditions)
After the Pure PRP Protocol, collect all plasma above the erythrocyte layer.
After the Amber PRP Protocol, collect the buffy coat along with 2ml plasma above the erythrocyte layer.
Collect carefully PRP Layer.

Carry PRP to the Re-suspension Tube.
Apply again the same protocol for the other PRP Tube.
Carry again PRP to the Re-suspension tube.
Gently shake the Re-suspension tube for 30 seconds to homogenize the settlement of the possible clumped cells in the plasma milieu. (Re-suspension process)
Attach the application needle (Green Needle - 21G) to 1ml Luer-Lok syringe.
Collect the re-suspended PRP inside from the Re-Suspension Tube.
Change application needle (green needle - 21G) to injection needle (yellow needle - 30G)
Apply the injection method to the patient.

Storage, Shelf Life and Handling Information

Do not expose to direct sunlight.
Do not use if the inner sterile blister package is damaged or opened.
Shelf life (Product Lifecycle) is the expiration date on the 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.
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 human. It is just intended to be used to collect PRP Layer inside from the PRP Tube(s).

Patient Profile and Possible Contraindicative Situations

Patient Profile

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.

Possible Contraindicative Situations