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Description

This product is a sterilized product with gel-type, no toxicity by building bridge hyaluronic acid which is extracted from microorganisms.

This bridged hyaluronic acid is provided embedding in a disposable syringe, and must be injected into 1 patient only, and should not be dispensed and injected into 2 persons. The packaging quantity or capacity of the product is specified on outside the packaging box.

This product is a disposable sterile medical device, autoclaving (121 ° C, 18 minutes) and should not be reused.

Intended use

Temporary improvement for the facial wrinkles of adult through physical recovery by injecting bridging hyaluronic acid, including lidocaine (Beads Max™ 1ml), into the skin

Ingredients

Hyaluronic Acid 20mg/ml

Lidocaine Hydrochloride 3mg/ml

Area of use

Breast and buttock augmentation

Injection are

Deep dermis, subcutaneous tissue shallow

Preparation in advance of use

1. Do not open the vial before use to prevent contamination.
2. Determine the area of application and the amount of use.
3. When opening a vial, prevent contamination from a falling or contact with other items.
4. It should be used by professional medical personnel who are well acquainted with the method of use.

Methods of storage and management after use

Open vial must be used immediately to avoid contamination. After use, it should be discarded properly as the medical waste regardless of the amount of remaining product.

Instruction for use & manipulation sequence

1. Check the packaging status and the content of the product.
2. Acquaint enough yourself with the manual.
3. Use sterilized and packaged product.
4. Remove the packaging carefully and take out the syringe.
5. Open the packaging and check the injected capacity in the syringe, and check if any distortion, crack, or damage of the appearance.
6. In order to prevent contamination, select needle syringe which isfit to the position to be injected and open the cap of the syringe, and connectthe needle of syringe.
7. This product must be injected into the dermis.
8. Dispose after the use of amount inside the syringe due to the selection of user.
9. For 1ml face filler product, Ultra-thin wall 25G 13mm injectionneedle (with 0.4mm if internal diameter) is recommended in case of the product that does not enclosed a needle.
10. During administration, it is recommended that the bevel of the end of needle should face upward, the shape of the needle can be seen from underneath the skin as the depth of the injection. meanwhile the silhouette of needle under the skin cannot be seen clearly and once the syringe is in place, slowly inject Beads Max™ while insert the needle into the skin as next, withdraw the needle at the same angle as insertion, do not push the plunger during the needle is withdrawn from the skin, to prevent Beads Max™ leaking from the needle point. To achieve the desired result, the injection should be into the deep dermis. If the injection is too deep or inner layer of the muscle, the hyaluronic acid will be degrades rapidly, causing the duration time to be shortened. If the injection is too light may result in bluish discoloration of the skin or bulging.
11. For 10ml body filler product, it is recommended to use 16~18G Cannula (Semi-permanent cannula). Insert cannula into the fat layer, then using a controlled shake and turning motion to breaks up the fat tissues and allowing the fat layer to make space before injection.*For breast augmentation, injection should be done at the top part of breast. Do not inject from the bottom part of the breast, otherwise ptosis or sagging may occur.

The most ideal mechanical properties of fillers can be categorized into the following three:

1. Strong viscosity and cohesiveness
2. Optimum gel hardness (gel hardness can be controlled delicately)
3. Excellent in easy molding

The brand possesses all these three ideal mechanical properties with strong viscosity (cohesiveness) and migration resistance; effective gel hardness that allows  delicate control of G (gel hardness) range that results in an excellent mold ability. Moreover, our product applies the unique technology of creating a semi-solid state gel of Hyaluronic Acid.

Brand applies innovative Hyaluronic Acid technology to increase longevity (long-lasting) effect, safety and increase removability (safe & removable) to produce the most ideal product.

MCL technology

Companies of conventional fillers that claim to have created a long-lasting HA filler tell us that they have achieved in raising the cross-linking rate. However, most products have only raised concentration and particle size due to limitations in the cross-linking technology. This does not contribute to longevity of the product. Moreover, products that merely increase concentration results in a product that is not easily moldable.

Brand applies the patented 3 staged microbead processing technology that allows to increase the viscosity and produce a long-lasting filler. By controlling the cross-linking rate to adjust the viscosity, we are able to produce a wide range of high quality fillers depending on its use.

Patent 3 Staged Microbeads Hyaluronic Acid Cross-linked Technology

Picture of viscosity test  (after 4 minutes)

Running a viscosity test with competing products we can see that after 4 minutes most of the competing product has migrated outside the circle whereas BeadsMax™ shows intact shape.

Increased concentration

Products that have raised concentration to 50mg/ml does not provide easy moldability (most fillers have a concentration of 20mg/ml). These products have not improved their cross-linking technology and therefore uses conventional cross-linking technology that does not contribute to a long-lasting effect.

Increased particle size

Due to limitations in the conventional cross-linking technology, that competing products cannot achieve microbead formations. The low cross-linking rate technology applied by conventional products does not contribute to long-lasting effect (3-12 months).

Brand has overcome the problems faced by increasing the cross-linking rate, to create a safe and removable product. Issues faced when increasing the cross-linking rate of Hyaluronic Acid and the strengths of our product is as follows.

Safety

Generally we can see how the raw material (Hyaluronic Acid) is easily chemically modified on high cross-linking rates. However BeadsMax™, as seen in the refractive index test, shows a wavelength pattern that is exactly like its raw material, showing that the final product has maintained 100% its HA without any modifications. In other words, the product can be safely absorbed by the human body without any harm, and both the raw material and the final product are 100% HA.

High hydrophilic capacity

Brand shows excellent hydrophilic capacity, which means that compared to the same amount of competing products, our product shows higher volumizing effect. Moreover high hydrophilic capacity means easy molding.

Removable

You don’t have to worry about unsatisfactory results after injection. BeadsMax™ is strong against natural hyaluronidase inside the body, but can be completely removed by injecting hyaluronidase. Then the filler left in the soft tissue can be completely removed. It is easily removed.

For 10ml body filler product, it is recommended to use 16~18G Cannula (Semi-permanent cannula). Insert cannula into the fat layer, then using a controlled shake and turning motion to breaks up the fat tissues and allowing the fat layer to make space before injection.

For breast augmentation, injection should be done at the top part of breast. Do not inject from the bottom part of the breast, otherwise ptosis or sagging may occur.

General Precautions

1. This product is a sterilization product, it must be kept as sterilization status not to be contaminated during the treatment period.
2. Before the procedure, the physician should explain to the patient for the operation indication, banned items, and potential side effects of this product.
3. Check if any of the sterilization condition is damaged, before use.