The application of Aquacore® hydrophilic gel is to be performed by certified medical staff only, holding all appropriate qualification according to the above mentioned indications.
FORBIDDEN TO USE AND STORAGE product if sterile container was open more than 2 hours ago.
FORBIDDEN to use product from one container for more than one patient.
- Doctor should inform the patient about expected results, possible adverse events/effects or complications before any invasive medical procedure.
- A written informed consent for body contouring procedures should be obtained in accordance with local regulations (each medical institution uses its own version of the informed consent) before any medical procedure relevant to gel implantation\body contouring.
- Every medical facility that performs the procedure, must keep hardcopies of informed consent signed by patients as a sign of patient’s understanding and acceptance of expected results and consequences of the procedure.
- Before treatment procedure it is necessary to take patient’s photo
- Before procedure a patient has to be examined for general health conditions: blood analysis, AIDs, Hbs Ag, Anti HVC, RW test, ECG, coagulogram, urine test
- Prior to the procedure all patients must be examined with ultrasound or mammography to make sure that mammary gland has no pathological changes.
- Before starting the procedure preliminary marking of the treatment area should be performed.
- All treatment procedures and manipulations are to be performed in strict aseptic and antiseptic conditions. Proper disinfection of the treatment area must be performed prior to injection.
- To prepare product for use, open the secondary package and pull the sterile PVC container with a sterile instrument out the secondary pack. Check the integrity of the container with gel, check Luer-lock integrity. To open the PVC container with gel break the protective plastic sealing tip. After that, it is necessary to unscrew the plug on Luer-lock and push protective plastic sealing tip deep into PVC container with a sterile needle or cannula. Connect a disposable syringe to the Luer-lock gate and fill the syringe with the gel. It is necessary to repeat the procedure to fill all syringes needed. Avoid creation of air pockets inside syringe tube during the filling procedure. After a syringe is already filled it should be connected with appropriate cannula by the Luer- Lock combi-stopper. It is important to use an appropriate cannula which can be properly assembled to the syringe. Press and turn a cannula clockwise into the syringe Luer-lock until it is tight. Make sure that the cannula is tightly fixed to the bottom of the Luer-lock. Before injecting, the air should be removed from the syringe up to the point where a droplet is visible at the tip of the needle. The equipment is ready to be used.
- The body contouring procedures with Aquacore® hydrophilic gel usually are performed under local anesthesia by injecting e.g. 0.5% lidocaine at the injection point and into the area where contouring procedure is performed.
- The injection technique may vary with regard to the place of injection and the administered quantity of Aquacore® hydrophilic gel. A correct injection technique is important for the satisfactory final result of the treatment.
If product injection is planned to be performed with cannula, use the needle to prepare injection opening for cannula insertion. For safe using of Aquacore® hydrophilic gel it is important to use a sterile needle/cannula of the appropriate diameter depending on a type of a performed procedure. For corrections of minor skin irregularities thin needles G-27-30 are recommended. In case of any postoperative soft tissue deformities it is necessary to use G-24-27 needles. Thin 2-2,5 mm blunt cannula of 80-120 mm of length should be taken for breast augmentation and the 2.0-2.5 mm cannula of 100-150 mm of length should be used for buttock contouring.
- During the breast augmentation, gel should be injected strictly into the retromammary plane between the mammary gland and chest muscule. After insertion of cannula the gel injection is performed from the center of retromammary space to periphery in an inversive, fan-shaped manner. Inject the hydrogel changing the cannula direction. The injected hydrogel must not cause excessive pressure on the tissue. Try to avoid injection of gel superficially especially on breast periphery. Carefully estimate the volume of Aquacore® hydrophilic gel to be injected and avoid overcorrection.
- For buttocks contouring with Aquacore® hydrophilic gel the gel should be injected subfascially between buttock deep fascia and gluteus muscle. After insertion of cannula, gel injection is made from the center of the treated area to the periphery in an inversive Inject the hydrogel by changing the cannula direction making in a fan-shaped manner. Try to avoid injection of gel superficially or avoid overcorrection
- Do not apply extensive pressure to the syringe at any time. If such resistance is encountered the needle/cannula should be partially withdrawn and repositioned or fully withdrawn and checked for obstructions.
- Special caution should be exercised when treating areas in close proximity to vulnerable structures such as nerves, vessels, ligaments or muscles.
- Inject the hydrogel while pulling the cannula slowly outwards. Carefully consider the volume of gel to be injected depending on the area of injection. Perform gel injection in small portions and spread them around the area to be augmented and not inject gel in one whole portion. Injected hydrogel must not cause excessive pressure on the tissue. Avoid overcorrection. When the desired volume of hydrogel has been administered, release the pressure on the plunger before removing the cannula. If an injection had caused lumps at the treatment area remove any excess material from the injection channel before finishing procedure.
- To prevent gel leakage through the skin puncture opening to outside, soft tissues at the injection site should be pressed by a finger.
- If needed, perform a gentle massage after injection to achieve an even distribution of the hydrogel.
- The injection opening should be closed with a sterile dressing.
- If it is necessary to perform additional injections of Aquacore® hydrophilic gel, they must be performed with 2-3 months’ interval.
THE PRODUCT SHOULD BE USED WITHIN 2 HOURS AFTER OPENING OF THE PACKAGE. The syringes and container must be discarded immediately after the treatment session ends and must not be reused due to risk for contamination of the unused material and the associated risks, including infections.
Disposal should be performed in accordance with accepted medical practice and applicable national, local or institutional guidelines.
the detailed photographic documentation must be the part of medical documentation in accordance with local legislation.