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The Name or Trade Name of The Medical Device
The product is a Microlyzer Cartridge, non-sterile, re-usable medical device.
The Name and The Address of The Manufacturer
Intended Use of the Device
Microlyzer 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. Indications for the use of Microlyzer 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).
Precautions, Warnings, Measures to be Taken and Limitations
- Devices are supplied non-sterile and require cleaning and sterilization prior to use.
- Blade-Filter is a single use device, do not reuse.
- Cartridge is a reusable device, therefore requires cleaning and sterilization before use.
- Before, during and after use, always inspect the devices and syringes to ensure properly mated surfaces and fitness of use.
- The healthcare facility should ensure that the combination of cleaning and sterilization used to actually results in devices that are safe for use in surgery.
- Patient selection, patient safety precautions and appropriate anesthesia methods are required prior to 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 general risks associated with treatment and possible adverse effects.
- Do not dispose of this product in the unsorted municipal waste stream.
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.
Performance of the Device Intended by the Manufacturer
Microlyzer Cartridge is a closed filtration system used for the emulsification of adipose tissue. Cartridge has two female-to-female luer-lok to connect to two syringes for the transfer of tissue. Cartridge is compatible and shall be used with Microlyzer Blade-Filter with different sizes, 2400 micron, 1200 micron and 600 micron. User shall manually transfer the tissue back and forth between syringes. User shall use the blade-filters in order from largest to smallest size until desired consistency and viscocity 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.
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.
Device can be used for superficial fat replacement to restore thinning skin to a more youthful condition and to enhance the skin quality. Autologous fat grafting can be used for the following clinical applications:
- Tissue Augmentation
- Breast Augmentation & Reconstruction
- Gluteal Augmentation
- Fibrosis and Scar Treatment
- Scar Contractures
- Radiation Damage
- Dupuytren and Other Hand Contractures
- Scleroderma/Systemic Sclerosis
- Facial Contour
- Clean and sterilize all devices prior to use.
- Place Microlyzer Blade-Filter 2400 into Microlyzer Cartridge and screw the cartridge to close.
- Attach the desired size syringe holding the fat graft to cartridge by luer adaptor in the direction indicated by the arrow. Attach an empty syringe of the same size on the other luer adaptor.
- 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 cartridge.
- Use Microlyzer Blade-Filter 1200 and Microlyzer Blade-Filter 600 to further emulsify the fat graft.
- Transfer the fat graft into new syringe for further processes.
Cleaning and Sterilization Procedures
This document is intended to give general guidance for cleaning and sterilization of supplied non-sterile, reusable device.
Equipment, operators, cleaning agents and procedures all have a contribution to the efficacy of device processing, and the health care facility should ensure that the combination actually in use results in devices which are safe for use. Alternative methods of processing may be equally suitable. In the event of conflicting National cleaning and sterilization requirements, these should prevail over T-Biyoteknoloji recommendations. The information provided as guidelines only, T-Biyoteknoloji relies on the Surgeon or Facility to decide on the best cleaning techniques and/or sterilization methods available for cleaning and sterilization.
Staff should use suitable protective clothing and equipment at all times. In particular, take note of the instructions provided by the cleaning agent manufacturer for correct handling and use of the cleaning agent(s).
This document pertains to reusable devices only and these instructions are not intended for devices labeled “For Single-Use Only.” T-Biyoteknoloji single-use devices must not be reused or reprocessed. Please refer to the device label and the package insert to identify the instruments as “For Single-Use Only” or “Reusable.”
Pre-Cleaning & Decontamination
Unscrew the cartridge, remove blade-filter and separate as medical waste. Remove excess debris with a brush. Instruments should be cleaned within 30 minutes of use to minimize the potential for drying prior to cleaning. Prepare to presoak the device in a basin large enough to accommodate the device using an enzymatic cleaner according to the cleaning agent instructions.
Place devices in a solution as per enzyme solution manufacturer instructions using lukewarm (22-43°C) tap water. Completely submerge all instruments in the enzyme solution and soak for at least 15 minutes.
Cleaning & Sterilization
Rinse cartridge free of debris and organic materials under warm (not hot) running tap water (22-43°C) in a basin large enough to accommodate the rinse. Clean the inside of the cartridge and luer adaptors.
If needed, using a syringe, completely flush each luer adaptor at least 3 times with lukewarm (22-43°C) tap water mixed with the enzymatic cleaning agent as described by the manufacturer of the cleaning agent. Make sure there are no blockages and rinsing freely flows through. Visually inspect cartridge and syringe connections to make sure it is non-greasy and unclogged.
Prepare an ultrasonic bath with an enzymatic cleaning solution or a solution of ultra-filtered, RO, DI, distilled and/or demineralized water and neutral pH (7) enzymatic detergent effective in removing organic material. Sonicate for 15 to 20 minutes at 45-55kHz. Change solutions frequently, or as often as the cleaning solution manufacturer recommends.
Following ultrasonic process, rinse twice with ultra-filtered, RO, DI, distilled and/or demineralized water.
Visually inspect for remaining contaminants and dryness. Prior to autoclaving, all internal and external compartments of cartridge should be dry and completely clean. If contaminants remain, repeat the cleaning process. Once cleaned and inspected, the dry cartridge should be packaged for autoclave. Steam sterilization (moist heat) is recommended. Healthcare facilities should validate the process that they use, employing the actual equipment and operators that routinely process the devices. Once purchased, Microlyzer Cartridge arrive in non-sterile pouches, labeled to identify each device and should be cleaned and sterilized before initial use.
Symbols and Explanations
European Medical Devices Directive 93/42/AT 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.
Reusable devices are supplied non-sterile and require cleaning and sterilization prior to use.
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.
MCR1 IFU.R00 | Release Date: 26/04/2019 | Revision Date: -