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Table of Contents:
- The Name of The Medical Device
- The Name and The Address of The Manufacturer
- Product Content List
- Intended Use of The Product
- Indication for Use
- Possible Contraindicative Situations
- The Performance of The Device Intended by The Manufacturer
- Clinical Safety Information
- Patient Profile
- Residual Risk and Side Effect Information
- 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
Fat Processor 2400, Fat Processor 1200, Fat Processor 600 and Fat Processor 41 are sterile single use devices.
The Name and The Address of The Manufacturer
Product Content List
The content of the packaging is one of the following:
- Fat Processor 2400
- Fat Processor 1200
- Fat Processor 600
- Fat Processor 41
Intended Use of The Product
FAT PROCESSOR is designed to be used for the safe and rapid emulsification and homogenizing of harvested adipose tissue into desired consistency or viscosity as deemed necessary by the clinical use requirements of fat graft.
Indication for Use
Indications for the use of FAT PROCESSOR include intradermal injection for the correction of fine wrinkles, intra and subdermal injection for the correction of sun damage and intra and subdermal injection for the correction of skin discoloration.
Possible Contraindicative Situations
Do not use the device, if it does not meet the requirement(s) for use in the intended surgical procedure(s).
Performance of the Device Intended by the Manufacturer
FAT PROCESSOR is a closed filtration system used for the emulsification of fat tissue. The device includes two components either a stainless-steel blade-filter or a polyamide filter and a single-use polycarbonate processor. The processor has two female-to-female luer-lok to connect to two syringes of same size for the transfer of tissue. User shall manually transfer the tissue back and forth between syringes. User shall use the blade-filter in order from largest to smallest size until desired consistency and viscosity is achieved.
Adipose tissue has many natural reparative characteristics that help to support a healing environment and to rejuvenate the tissues throughout the body. Adipose tissue provides cushioning and support of normal tissues in the body by the action of growth factors up-regulating collagen and elastin production.
Clinical Safety Information
The safety and efficacy of this device have been proven by the Risk Analysis Report and Clinical Evaluation Report.
Fat grafting is an autologous application 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. The safety and effectiveness of fat treatment have not been established in children and pregnant women.
Residual Risk and Side Effects Information
According to the risk assessment, risk management, risk report procedures of this device, residual risks are at an acceptable level, therefore the benefits gained from using the device are greater than its risks. With respect to the requirements of Essential Requirements, 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.
Possible Adverse Events
- Bruising and swelling
- Fat Necrosis
- Embolization due to injection of fat into veins or muscles
- Temporary or permanent nerve damage that may result in pain or numbness.
- Early or late postoperative infection.
This product should be used by qualified surgeons or surgeon-directed allied health care professionals with adequate training in the use of the device.
Medical Devices to Be Used with The Device
The user shall choose the syringe volume to be used based on the application and volume of fat to emulsify. FAT PROCESSOR is compatible with luer-lock syringes sized 1ml, 5ml, 10ml, 20ml, 50ml & 60ml. T-Biyoteknoloji recommends 10ml and 20ml syringes to be used with the processor for the ease of back and forward movements and avoiding loss of tissue in the processor. The user shall use two of the same size syringes for the process.
Fat Processor 2400, Fat Processor 1200, Fat Processor 600 and Fat Processor 41 are ready-to-use devices with the blade-filters embedded in.
- Open the box.
- Open the sterile blister packaging.
- Attach the desired size syringe holding the fat graft to the processor via luer connectors in the direction indicated by the arrow. Attach an empty syringe of the same size on the other luer connector.
- Manually force the fat graft back and forth between syringes until desired consistency and viscosity is reached.
- At the end of the process, ensure that the fat graft remains in the syringe that is on the outlet direction of the arrow marking on the processor.
- Use blade-filter 2400, 1200, 600 and 41 in order to further emulsify the fat graft.
- Transfer the fat graft into new syringe for further processes or injection.
Storage, Product Life and Handling Information
- FAT PROCESSOR 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.
- 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
- FAT PROCESSOR is ready-to-use sterile devices, do not reuse them.
- Do not use the sterile components if the package is opened or damaged.
- Patient selection, patient safety precautions and appropriate anesthesia methods are required prior to the use of the device(s).
- 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.
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.
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
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.
TF05 IFU.R02 | Release Date: 21/01/2019 | Revision Date: 28/01/2020