FRAXX System JUL 2022 EN

4 MHz HIGH FREQUENCY TECHNOLOGY

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ISO13485 CERTIFIED

QUALITY - P R E C I S I O N SAFE T Y - E X P E R I E N C E www.loktal.com

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Touch Screen

4 MHz High

Wide

Deep

Weight

Line Voltage

Output power

Operating Frequency

133 mm

243 mm

305 mm

5,2 kg

115/230V - 50/60 Hz

100 Watts

4 MHz ±10%

The Fraxx System, is a complete multi-use platform, with an amazing High Frequency ESU, Wavetronic 6000 Touch, that produce biophysical effects similar from laser technology, is untraumatic and gentle method, precise for cutting and coagulation of tissues, through electromagnetic energy in the Megahertz Range (MHz).

The lateral heat developed around cutted tissues, with Megahertz Range is significantly lower instead of Kilohertz range (KHz).

Adjacent tissues do not present thermal damage undergo and incision result in quality pieces for histological examination, as an “Cold Scalpel”.

Megahertz range High Frequency technology, provides an excellent quality incision with minimum bleeding,fast healing, minimum discomfort with maximum aesthetic results and small post op downtime.

Megahertz Range Low thermal damage on tissue

Kilohertz Range High thermal damage on tissue

LABIOPLASTY

ADVANTAGES

•Best cost effectiveness •Maximum of the High Frequency 4MHz •Best efficiency, compared to old ESU on the Kilohertz range •Wide range of surgical electrodes for multiple specialties •The FRAXX System, with the Wavevac Dual smoke evacuator, integrates a complete, compact and versatile solution for several applicability Before

After

TREATMENTS

• Sagging Skin • Wrinkles • Eyes Dark Circles • Skin Spots • Acne Scar • Hypertrophy Scar • Facial Rejuvenation • Body Rejuvenation • Stretch mark • And much more High

Wide

Deep

Weight

Line Voltage

Output power

133 mm

243 mm

305 mm

2,6 kg

115/230V - 50/60 Hz

100 Watts

FRAXX

Fraxx System with an exclusive SmartShot control, uses fractional random shots from RF Radio Frequency technology that distribute precise micro sub ablative energy, with minimal Epidermis thermal effect and significant dermal deep impact, produced by dual layer thermal effect technology DDP. With this unique random energy distribution feature called SmartShot, FRAXX System provides a perfect effect, known as thermal relaxing time, that keeps the adjacent tissues to the vaporized microdots, complete intact and healthy to forming new collagen.

The effect promotes the dermis regeneration into papillary with reticular layer interface, through fibroblast stimulation with subsequential collagen synthesis and elastics fibers formation, just as well as epidermal regeneration by migrating keratinocytes •Resurfacing and Tightening effect: Skin resurface occurs by skin’s collagen in contraction and renew.

•No large crusts: Unlike dermal abrasion and deep peelings, the micro fractional radio frequency produces micro crusts that leaves the treated area, on five to seven days after treatment.

•Minimum Downtime: Recovery is quickly, allowing patients return to normal daily activities almost immediately ADVANTAGES

•Personalized treatments, with Four different treatment programs: LOW Mode, MEDIUM Mode, FREE Mode and the amazing new SIC Mode – Skin Impedance Control, working for different depth level penetration according to the skin type and individual treatment requirements. Carefully selected energy level provides the precisely amount of RF energy in the exact layers at each skin area touched by the micro fractioned tip.

•Low complication risk, minimum downtime and rare side effects for some high phototypes that present chance of Hyperpigmentation, compared to laser treatments.

•Modern Design: The touch screen control, provides easy and friendly interface for all user level.

FRAXX FRACTIONAL TIP FOR VULVAR AND FULL BODY TREATMENT

Skin

INDICATIONS •Vulvar Atrophy •Dryness •Urethral Caruncle •Vestibule Problems (fissures and pain) •Problems in the Vestibule (cracks and pain) •Regenerative Treatment of the Vulva •Vulvar Sagging •Lichen Sclerosis •Among others

VAGINAL ATROPHY NEW TREATMENT

THE UP TO DATE ON MICROFRACTIONED ELECTROMAGNETIC ENERGY

INDICATIONS

•Geniturinary Syndrome of Menopause •Vaginal and Vestibular Atrophy •Vaginal Dryness •Dyspareunia •Urinary Incontinence selected cases •Vaginal Regenerative Treatment •Vagina Sagging •Among others

SAFETY AND PRECISION THE UNIQUE SYSTEM IN THE WORLD, WHERE YOU CAN SEE THE PROCEDURE !

Vaginal Cupola

WAVEVAC DUAL

Smoke Evacuator DMA (Dual Mode Activation) Automatic and /or Manual High

Wide

•Exclusive DMA System (Dual Mode Activation); 133 mm 243 mm provides a remote or manual activation system •Double filtration system H.E.P.A. and charcoal with 99,99% efficiency and maximum protection against HPV virus •Nylon coated speculum with suction duct.

•Maximum protection for medical team •Wide surgical field visibility BIPOLAR FORCEPS

SPECULUM Autoclavable vaginal speculum with nylon insulation and suction duct Sizes: •Small •Medium •Large

Deep 325 mm

Weight

Line Voltage

4,0 kg

115/.230V - 50/60 Hz

•High frequency bipolar coagulator “Non Stick” for micro and macro coagulation •It works with any bipolar forceps, also with laparoscopy forceps •Can be used in wet surgical field •Several bipolar forceps available Visit website for all options

Reusable Silicone Bipolar Cord

COATED MICRO NEEDLES HAND PIECE

Directions: Epilation, Trichiasis, Telangiesctasia, Epilation of hair follicles, Aesthetics removal of superficial spider veins

Two Autoclavable HandPieces Options: footswitch and fingerswitch control

WAVEVAC DUAL SET PATIENT RETURN ELETRODE •Reusable insulated (nylon coated) neutral plate with 03 meters cable lenght •Electric shock or burns protection •Monitoring of failure or lack of neutral plate, with audio-visual alarms

High Frequency System with Automatic Smoke Evacuator Activation

WATERPROOF FOOTSWITCH CUT/COAG Waterproof protection - IPX7

LLETZ ELECTRODES 120MM LENGHT

ACCESSORIES

needle Ø 0,3mm x 10mm ACEL0153* Micro Swetz

ACEL0154

Micro needle Ø 0,5mm x 15mm Glandular holes cauterization.

ACEL0155

Ball Ø 3mm.

Hemostasis and coagulation

ACEL0156*

Ball Ø 5mm.

Hemostasis and coagulation

Ø 5mm.

ACEL0157* Loop Endometrial biopsy, vagina and vulva

ACEL0158

Square loop 10mm x 4mm.

Vulvar lesion excision

ELECTRODES Wide variety of electrode models, reusable and single use, for the most medical specialties and several surgical procedures. Bendable insulated shaft and easy adjustable, are manufactured with surgical tungsten wire, ensuring highest quality and durability. Nonstick Surgical Blades (knifes), Needles, Loops and Balls electrodes features PTFE coating, enabling surgeon use low power, preventing hypertrofic scars and unwanted side effects.

Bendable

20mm x 10mm.

ACEL0159* Loop Large excision and conization

*Standardized electrodes (equipment)

15mm x 10mm.

ACEL0160* Loop Large excision and conization

Tungsten Filament Surgical Grade

10mm x 10mm.

ACEL0161* Loop Large excision and conization

Non Stick Ball

loop 10mm x 10mm.

ACEL0162* Square Cervical canal excision

loop 10mm x 15mm.

ACEL0163* Square Cervical canal excision

ACEL0164

Loop 15mm x 15mm.

Large excision and conization

ACEL0165

Loop 25mm x 10mm.

Large excision and conization

ACEL0166

Loop 25mm x 15mm.

Large excision and conization

Ceramic Cutting Limiter

Regular Ball

Insulated Shaft

LOKTAL ELECTRODES TECHNOLOGY

ACEL0167

Loop 30mm x 10mm.

Large excision and conization

ACEL0168

Loop 30mm x 15mm.

Large excision and conization

ACEL0169

Loop 20mm x 4mm.

Large excision and conization

ACEL0170

Loop 15mm x 4mm.

Large excision and conization

ACEL0171

Loop 10mm x 4mm.

Large excision and conization

“WAVECART” TROLLEY

LLETZ

Developed for safe move and storage of the system and its acessories.

DERMATOLOGY · PLASTIC SURGERY · OPHTHALMOLOGY ELECTRODES

Eletrosurgical

ACEL0132 Electrode

ACEL0136

Micro Ball Ø 1mm 45° angle.

Eletrosurgical Electrode

LACRIMAL DUCT CLEARANCE ELECTRODE

Eletrosurgical Electrode Knife Curva

Eletrosurgical Electrode Loop

ACEL0133 Ball Ø 1mm .

ACEL0140* Ø 5mm, Straight.for Biopsy and Lesion of Exeresis.

ACEL0134

Eletrosurgical Electrode Ball Ø 2mm 45° angle

Eletrosurgical Electrode Loop,

ACEL0142* Ø 7mm, Straight for Biopsy

LIMA MULTINEEDLE ELECTRODES

Eletrosurgical Electrode Loop,

ACEL0143 Ø 12mm, Straight. for Biopsy

Loktal reserves the right to change technical specifications without prior notice. Merely illustrative images. *Standardized electrodes (equipment)

® ACEL1460 Electrode Multi Needle LIMA 8

Needle Length 1 mm.

and Lesion of Exeresis.

Electrode Ball ACEL0139* Eletrosurgical Ø 3mm, Straight. for Coagulation e Vaporization.

Eletrosurgical ElectrodeLoop Triangular,

Multi Needle LIMA 8® ACEL1456 Electrode Needle Length 2 mm.

ACEL0144* 9mm x 9mm x 9mm, Straight. for Biopsy and Lesion of Exeresis. (Shaving)

ACEL0137

Flexible electrode for tear duct.

and Lesion of Exeresis.

Electrode ACEL0135* Eletrosurgical Ball Ø 2mm.

ACEL0138

ACEL1507

Eletrosurgical Electrode

ACEL0019D Micro needle Telangiectasia, Epilation and Coagulation of Micro Vessels.

Eletrosurgical Electrode Ball Ø 5mm.

ACEL0145

Eletrosurgical Electrode Knife Straight Short.

Eletrosurgical Electrode Square loop10mm x 10mm, Straight. for Biopsy and Lesion of Exeresis.

NEEDLE ELECTRODES

Universal Eletrosurgical

ACEL0141* Electrode for Cut,

FRACIONATED ELECTRODE

Body use

Adjustable Depth (replaces the blade).

Skin

ACEL0236 and ACEL0237

Eletrosurgical Electrode Curved Micro Incision, 45°angle.

50mm and 75mm Length.

ACEL0806

Eletrosurgical Electrode Blunt Needle, 45°angle, 50mm, Length.

BIPOLAR FORCEPS LOKTAL

ACEL0805 and 0807

ACPI0005

The n°1 choice among the sucessful surgeons

Eletrosurgical Electrode Short Needle, 50mm and 75mm Length.

Hemostatic Forceps Bipolar Micro Tip 45° angle Autoclavable, 10 cm.

ACEL0238 and ACEL0239

ACPI0006 - 12cm

Eletrosurgical Electrode Precision Micro Incision Straight.

50 mm and 75mm Length.

See all models available

ACPI0009 - 16cm.

Point your cellphone

F O R C E P S W I T H E XC LUS IV E AUTOCL AVAB LE INS UL ATION AN D AU TO C L AVABL E BIPO L AR CABL E.

ACEL0238

Eletrosurgical Electrode with Micro Incision 50mm Length.

FRAXX SYSTEM MICROFRACIONATED 4MHZ ENERGY ON 3 OPERATING MODES THRU, TOUCH SCREEN TECHNOLOGY 1) SURGICAL MODE

2) PULSED MODE

•Microprocessed High Frequency Cell Volatilization ESU; •Two Bipolar options: Macro and Micro Precision Bipolar; •Electromagnetic duty cycle 4.0 MHz; •Touch Screen Panel •Output power: 100W; •Output power accuracy: 1watt for each operating mode;

PULSED FUNCTION

SEVEN OPERATION MODES: •PURE CUT - 90W •BLEND 1 - 80W (90% cut and 10% coag) •BLEND 2 - 70W (70% cut and 30% coag); •BLEND 3 - 50W (50% cut and 50% coag); •FULGURATION - 30W (spray coag); •PURE COAG - 100W •BIPOLAR - 50W (coag);

•Independent power memory setting for each function; •Double footswitch pedal CUT/COAG waterproof (IPX7); •Two Autoclavable Handpieces: Footswitch control or Fingerswitch control; •Smoke evacuator Remote control activation; •Audio-visual signaling with double tone activation - CUT (high) / COAG (low); •PCM Technology: Monitoring of the contact quality of the Neutral Plate with automatic stop of the Equipment in case of contact failure or lack of connection (continuity) of the Neutral Plate; •Audio-visual alarm in case of failure or lack of neutral plate; •Two Neutral Plate options: Reusable Nylon coated, adhesive single use non-split;

•Pulsed Frequency Control for Thermal Relax Time TRT management software; SINGLE PULSE FUNCTION

•Single Shot Time Control Management Software SST , milisseconds; 3) FRAXX MODE

•FRAXX MODE: An algorithm of three Management Softwares; For the ideal thermal effect, through the power equalization, DDP Dual Deep Power, which controls the time and intensity of the energy applied in the different layers of the Epidermis and Dermis. SIC, Skin Impedance Control that analyzes each type of tissue in microseconds.

In addition to the Smart Shot random distribution control, which prevents adjacent dots from heating up simultaneously, inhibiting the lateral thermal effect, protecting the tissue around the microdots, to create new collagen and cell regeneration.

4) TREATMENT PROGRAMS •LOW ENERGY: For gentle treatments that

require soft energy •MEDIUM ENERGY: For smooth treatments that require moderate energy; •FREE MODE: For treatments that require a customized control of the electromagnetic energy applied to the tissue.

•SIC - SKIN IMPEDANCE CONTROL: The innovative technology of self-analysis of skin impedance, which allows a high-precision application with quality and surprising results.

WAVEVAC

OPTIONAL ACCESSORIES:

•Smoke evacuator, "Wavevac Dual", complete with exclusive automatic activation system, which allows the operator to activate the "Wavevac Dual" through the Wavetronic 6000 Touch controls.

•Time Delay Off suction remains for six seconds more, for total cleaning of vaginal cavity; •Nylon coated reusable speculum with suction duct; •H.E.P.A. charcoal double filtration system •Plastic and silicone reducing hose

•Autoclavable fingerswitch handpiece, 3 (three) meters silicone cable; •Wave Cart trolley; •Two Autoclavable forceps cable options: Monopolar or Bipolar with 3 (three) meters;

STANDARD ACCESSORIES (INCLUDED)

•Autoclavable Handpiece with 3 (three) meters Silicone Cable Lenght; •Double footswitch CUT/COAG •Reusable nylon coated Patient Return Plate; •Non disposable Patient Return Plate cable, with 3 (three) meters and standard connector clip for all Plate options; •Electric Power Cord; •FRAXX Handpiece (Non Disposable) •Electrode for Vulva and Full Body Skin (Disposable); •Linly Electrode for Vaginal Cavity (Disposable); •Vaginal Cupola Electrode (Optional); •Wide range of eletrode available; •Digital Owner´s Manual.

STANDARDS

•Electric shock Protection (Class I); •Splash protection (IPX1); •Double fuse protection •Voltage supply, 115/230 V. 50/60Hz automatic; CERTIFIED BY STANDARDS:

•NBR IEC 60601-1 •NBR IEC 60601-1-2 •NBR IEC 60601-1-6 •NBR IEC 60601-1-9 •NBR IEC RDC - 16 ANVISA •NBR ISO 9001 •IEC 60601-2-2 APPROVED BY:

•CE- Certified by the European Community •ISO 13485 •BPF- Good Manufacturing Practices •Brazilian Health ANVISA - 10362619001

Visit our website: www.loktal.com

(+55 11) 3723-2890

(+55 11) 95315-0139

comex@loktal.com

Av. Trona Constanzo, 156 • Caxingui • CEP 05516-020 • São Paulo • SP • Brasil