China HDHFM003-2D 2IN1 HIFU F+V-HS Manufacturer and Supplier

HDHFM003-2D 2IN1 HIFU F+V-HS

Short Description:

High Intensity Focused Ultrasound (HIFU) directly delivers heat energy to skin and subcutaneous tissue that can stimulate and renew the skin’s collagen and thus consequently improving the texture and reducing sagging of the skin.

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HIFU Technology

High Intensity Focused Ultrasound (HIFU) directly delivers heat energy to skin and subcutaneous tissue that can stimulate and renew the skin's collagen and thus consequently improving the texture and reducing sagging of the skin. It literally achieves the results of a facelift or a body lifts without any invasive surgery or injections, moreover, an added bonus of this procedure is that there is no down time.and also, it works equally well for people of all skin colours, in contrast to that of lasers and the intense pulse lights.

It's heating directly to deeper tissue, in oder to lift the skin.It is performed in the office e with only ultrasound gel applied to the skin. An ultrasound screen image allows the physician to visualize the level of treatment before energy is applied to the targeted tissue. The treatment takes from 45 to 90 minutes depending on the area(s) treated.

Introduction to Manual

1.1. Purpose

This Instructions for Use manual provides a description of System components, its controls and displays, instructions for its operation, and other equipment information important to be user.

Warning: Do NOT operate the Ulthera System before reading this manual thoroughly. In addition to this manual, additional clinical training may be available by Company or your local distributor. For more information on training available please contact your local representative.

1.2. Conventions

Note: Notes designate information of special interest.

Caution: Cautions alert the user to precautionary steps necessary to properly operate the system. Failure to observe these cautions may void the warranty.

All procedures are broken down by numbered steps. Steps must be completed in the sequence they are presented.

Bulleted lists indicate general information about a particular function or procedure. They do not imply a sequential procedure.

Control names are spelled as they are on the system, and they appear in Bold text.

Medical Safety

2.1. Indications for Use

The Ulthera System is indicated for use as a non-invasive dermatological aesthetic treatment to:
● lift the eye brow
● lift lax submental (beneath the chin) and neck tissue

2.2. Contraindications

The Ulthera System is contraindicated for use in patients with:
● Open wounds or lesions on the face and/or neck
● Severe or cystic acne on the face and/or neck

2.3. Precautions

When not in use by trained personnel, the Ulthera System User Access Key should be removed from the system to help prevent unauthorized use. Keep the Ulthera System User Access Key in a designated place accessible only to authorized and trained personnel.

The Ulthera System has not been evaluated for use over various materials. Therefore, treatment is not recommended directly over those areas with any of the following:
● Mechanical implants
● Dermal filters
● Implanted electrical devices in the face and/or neck
● Metal stents in the face and/or neck area

Treatment energy is not recommended for use directly on an existing keloid.

The Ulthera System has not been evaluated for use in patients on an anticoagulant treatment plan.

It is recommended that the following areas should be avoided during treatment:
● Thyroid gland, Thyroid cartilage and trachea
● Major vessels

The Ulthera System has not been evaluated for use in the following patient populations:
● Pregnant or breast feeding women
● Children
● Those with the following disease states

○ A hemorrhagic disorder or homeostatic dysfunction
○ An active systemic or local skin disease that may alter
wound healing
○ Herpes Simplex
○ Autoimmune Disease
○ Diabetes
○ Epilepsy
○ Bell’s Palsy

2.4. Patient Safety

Warning: Ulthera should not be used on a patient’s eyes or in a location or technique where ultrasound energy can reach the eye.
Warning: Use this system only if you are trained and qualified to do so.
Warning: If any problems occur during system operation, take immediate action(s): lift the transducer off the patient’s skin, press the See pushbutton on handle to discontinue treatment in progress, and/or press the red emergency Stop button to completely half system operation.

2.5. Potential Side Effects

Side effects reported in the clinical evaluation of the Ulthera System were mild and transient in nature. These were limited to:
● Erythema(redness): The treated area may exhibit erythema immediately following treatment. This typically resolves within a few hours of treatment.
● Edema(swelling): The treated area may exhibit mild edema following treatment. This typically resolves within a few days of treatment.
● Pain: Momentary discomfort may be experienced during the procedure while energy is being deposited. Post procedure discomfort or tenderness to the touch is also possible.
● Bruising: Mild bruising, which is caused by damage to soft tissue blood vessels, may occur occasionally and typically resolves within a few days of treatment.
● Nerve Effects:

○ Transient local muscle weakness may result after treatment due to inflammation of motor nerve.
○ Transient numbness may result after treatment due to inflammation of a sensory nerve.
○ Transient pain, paresthesia and/or tingling may be experienced.

No permanent injuries to facial nerves have been reported.
● Scarring: The possibility for scar formation (which may respond to medical care) may exist if incorrect treatment technique is used.

2.6. Complaints and Adverse Events

No serious adverse events were observed during the clinical study evaluation of the Ulthera System. Ulthera follow MDR (Medical Device Reporting) rules for handing complaints and adverse events. Should an adverse event be suspected or reported, contact Ulthera, Inc. at the number on the cover page of this document; for those outside the U.S., contact your local Ulthera representative.

Energy Transmission Technology

DS-1.5mm used to transmit high-energy focused ultrasound to the epidermis tissue, the ultrasound to penetrate the skin to a depth of 1.5mm,is responsible for activating the skin epidermis in thinner tissue. such as eye zone.

DS-3.0mm for transmitting high frequency focused ultrasound energy into the dermis layer of the skin tissue, the ultrasound to penetrate the skin to a depth of 3.0mm, is responsible for activating the skin?s dermal layer of collagen, effectively enhance the effect of the consolidation of the outline, but also improve large pores and reduce the appearance of wrinkles. targeted to chin, chest.

DS-4.5mm used to transmit high- energy focused ultrasound to the skin, subcutaneous tissue, the ultrasound to penetrate the skin to a depth of 4.5mm, direct subcutaneous SMAS layer, targeted to thicker skin, such as cheeks, neck, etc.
principle:

Ultrasound focusing uses its unique high-energy focused ultrasound to reach the SMAS layer, enhances the SMAS fascia suspension, and comprehensively solves the problem of face and body sagging. It precisely focused the ultrasonic energy at different depths of the fascia layer and collagen layer, which make fascia layer muscle growth, achieving the best effect of shaping, lifting and firming; and make collagen recombined and regenerated, achieving skin elasticity, whitening, wrinkle removal, and fine pores. At the same time, because the energy is swept across the epidermis, there is no need to worry about the injury of the epidermis. The skin can be quickly lifted, tightened, and wrinkles can be smoothed quickly!

Portable ultrasound hifu body slimming machine 3cartridgers 5 cartridges

Vaginal tightening hifu head:
4.5mm heads produce the energy directly to the SMAS , make it thermal coagulation , make the SMAS tighten and lifting, let the muscles improved the muscle structure from deep to shallow, make better to help the muscle layer restor elasticity and tighten.
3.0mm heads produce energy up to submucosal tissue accelerate cell activity and make the collegen regrowth and restructuring, increase mucous elasticity and meke vaginal muscle tighten.

HIFU Advantages

1. It has different working heads for different operational areas:

--- 3.0mm is for the face dermis layer.
--- 4.5mm is for the face SMAS layer
--- 6.0mm/ 8mm/10mm/13mm/16mm for body fat layer.

2. Instead of the traditional surgical face lift with a non-invasive technique.

3. Tighten sagging skin, improve sagging and other signs of aging.

4. With a special transmitter, transmission from the skin surface conduction of high-energy focused ultrasound to the SMAS layer.

5. Non-invasive, no time to rest after treatment, ultrasound without injections, no trace wrinkle skin rejuvenation.

6. Fit any age, both men and women.

7. It's totally non-invasive and safe.

8. The effect will be shown after operation, the best effect will be seen after two months. It can be lasted for 2-3 years.9. No anesthesia or epidermal anesthesia, no pain, treatment more comfortable.

Skin Tightening Principle

HIFU machine is an advanced new high-intensity focused ultrasound technology designed instrument, change the traditional face lift wrinkle cosmetic suigery, non-surginal wrinkle technology, the Hifu machine will release high concentrated focus sonic energy can penetrate in the deep SMAS fascia skin tissue and coagulation of high heat in the proper position, the deep dermis to stimulate the skin to produce more collagen and thus to tighten so the skin becomes former. hifu can directly delivers heat energy to skin and subcutaneous tissue that can stimulate and renew the skin's collagen and thus consequently improving the texture and reducing sagging of the skin. It literally achieves the results of a facelift or a body lifts without any invasive surgery or injections, moreover, an added bonus of this procedure is that there is no downtime.

This technique can be applied to the face as well as the whole body, and also, it works equally well for people of all skin colours, in contrast to that of lasers and the intense pulse lights.

Fat Removal

Apply high intensity focused ultrasound, generate focused energy and go deeoer into the cellulite to break cellulite. it is an invasive, impressive and long- last effective tratement to reduce fat, especially for abdomen and thigh.

High intensity focused ultrasound target at fat of 13mm(depth of penetration), heating up the fat tissue, combine with high energy and good penetration to resolve the fat, during the treatment, the triglyceride and fatty acid excrete by the process of metabolism, and the vessal and nurve will not be damaged.