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SmartXide2 V2LR

SmartXide2  V2LR

SmartXide2 V2LR

Product catalog summary
Introduction
The document introduces the SmartXide2 V2LR system, a CO2 laser technology developed by DEKA for vulvo-vaginal laser reshaping, known as MonaLisa Touch™. This technology provides a non-pharmacological treatment for age-related vulvo-vaginal issues, particularly in postmenopausal women, addressing vaginal atrophy and laxity.

Specifications and Technology
The SmartXide2 V2LR system features a radiofrequency CO2 laser with Pulse Shape Design (PSD®) technology, offering various pulse shapes such as S-pulse, D-pulse, H-pulse, and U-pulse. The D-Pulse is specifically designed for treating vaginal mucosa, enhancing collagen biosynthesis and restoring the extracellular matrix.

Procedures and Applications
This system is utilized for treating post-menopausal atrophy, vaginal laxity, urinary incontinence, and vulvo-vaginal morphological changes. The procedures are minimally invasive, performed using DEKA's HiScan V2LR scanning system, ensuring precise and safe laser energy application.

Clinical Outcomes and Studies
Clinical studies demonstrate that MonaLisa Touch™ treatment effectively restores vaginal mucosa to a pre-menopausal state, alleviating symptoms of vaginal atrophy and urinary incontinence. Histological studies confirm tissue regeneration, with increased collagen production and improved epithelial structure.

Benefits and Advantages
The treatment is safe, minimally invasive, painless, and effective, significantly improving women's quality of life by addressing functional and cosmetic concerns without drug therapy side effects.

Conclusion
The SmartXide2 V2LR system offers a revolutionary approach to female genital health, providing a versatile tool for medical and cosmetic applications. MonaLisa Touch™ is highlighted as an effective solution for rejuvenating the vaginal environment and enhancing women's well-being.
Overview
The document provides technical details and specifications for V2LR applications, focusing on female genital functional and cosmetic laser surgery, particularly treating vaginal mucosa atrophy, laxity, and related urinary incontinence.

Technical Specifications
The HiScan V2LR Scanner System features a maximum scanning area of 8 x 8 mm, dwell time from 100 to 2000 µs, and DOT spacing from 0 to 2000 µm. It supports various scanning shapes and methods, with emission modes SP, DP, and HP.

Laser Specifications
The SmartXide2 configurations for V2LR models (C40, C60, C80) include a CO2 RF - PSD® laser type with a wavelength of 10.6 µm. The emission beam is TEM00, with power ranges specified for CW, SP, DP, HP, and UP modes.

Safety and Compliance
The laser is classified as a Class 4 laser product, adhering to IEC 60825-1 standards, emphasizing the avoidance of exposure to direct or scattered radiation.

Control and Accessories
The system includes a wide LCD color touch screen control panel and a range of surgical handpieces. It features an internal database with about 150 factory-stored protocols, upgradable via USB.

Company Information
DEKA M.E.L.A. s.r.l., a leader in medical laser technology, manufactures these devices in compliance with Directive 93/42/EC and ISO standards, operating globally with a strong emphasis on quality and innovation.
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Catalog excerpts

SmartXide2  V2LR-1

V2LR (Vulvo-Vaginal Laser Reshaping) SMARTXIDE2 Treatment of Atrophy and Laxity of the Vaginal Mucosa and Urinary Incontinence to Them Related Female Genital Functional and Cosmetic Laser Surgery MonaLisa Touch™ The New Era of Vaginal Rejuvenation DEKA Intelligent Technologies: Experts from the Start

 Open the catalog to page 1
SmartXide2  V2LR-2

A REVOLUTIONARY NEW APPROACH TO FEMALE SEXUALITY Like all the other organs in our bodies, the female genitals are not immune to the effects of time, especially during menopause. The genital tract is particularly affected by declining oestrogen production. Almost 50% of postmenopausal women complain about the typical symptoms of genital atrophy interfering heavily with their sexual experience and quality of life. Increasingly, relatively young and socially active women turn to specialists for treating this condition. DEKA has developed a breakthrough procedure for treating age-related vulvovaginal...

 Open the catalog to page 2
SmartXide2  V2LR-3

V2LR (Vulvo-Vaginal Laser Reshaping) SMARTXIDE2 V2LR V2LR CONFIGURATION OF SMARTXIDE2: A MINIMALLY INVASIVE TECHNOLOGY THAT ENHANCES QUALITY OF LIFE The SmartXide2 system, with V2LR configuration, offers the latest breakthrough laser treatment for vulvo-vaginal problems (MonaLisa TouchTM) and cosmetic/functional female genital surgery. Safe and minimally invasive, these procedures are the new alternative to: • pharmacological therapy for post-menopause atrophy of genital mucosa, using the MonaLisa TouchTM treatment; surgical treatment of vaginal laxity; annoying or invasive treatments of urinary...

 Open the catalog to page 3
SmartXide2  V2LR-4

VAGINAL ATROPHY: CHANGES THAT AFFECT QUALITY OF LIFE Menopause, whether natural or induced, determines a range of changes, involving virtually all organs and systems of a woman’s body. The end of oestrogen production by the ovaries is linked to the onset of disorders resulting from the vulvo-vaginal atrophy such as dryness, dyspareunia, vaginal irritation with itching and burning. Vaginal environment at different ages and physiological conditions. Electron microscope image of the inside of a fibroblast in the vaginal mucosa stimulated with SmartXide2 V2LR laser. The Rough Endoplasmic Reticulum...

 Open the catalog to page 4
SmartXide2  V2LR-5

DEKA developed the SmartXide2 V2LR system for the MonaLisa TouchTM treatment, capable of supplying energy with a specific pulse, derived from dermatological experience, but taking into account the peculiarities of vaginal mucosa: this dedicated pulse shape is called D-Pulse or DEKA-Pulse. Thermal Effect Pulse Duration D-PULSE: THE PERFECT PULSE FOR V2LR an initial part with constant, high energy peak power, for rapid superficial removal of the epithelial component of atrophic mucosa characterized by low water content; D-Pulse: the pulse specifically developed by DEKA for V2LR. a second variable...

 Open the catalog to page 5
SmartXide2  V2LR-6

MONALISA TOUCH TM: TOTAL TISSUE REGENERATION The new full-angle probe emitting the laser energy in a 360 degree angle in one time. Faster and less invasive treatments are now possible even for the more severe atrophies. With the introduction of fractional CO2 laser technology, DEKA V2LR procedure has given a new boost to the development of vaginal mucosa treatments. Thanks to the effective action of the D-Pulse, MonaLisa TouchTM improves and replaces also the most common techniques for treating vaginal relaxation. The term wide vagina usually refers to a condition where the diameter of the vagina...

 Open the catalog to page 6
SmartXide2  V2LR-7

The graphs represent the percentage of reduction for the main symptoms of vaginal atrophy and urinary incontinence after 3 MonaLisa TouchTM sessions. The study was carried out at the Department of Gynaecology of the San Raffaele Hospital on patients with symptoms of uro-genital atrophy. [Courtesy of S. Salvatore, M.D. - IRCCS San Raffaele Hospital. Milan, Italy] MONALISA TOUCH TM: HISTOLOGICAL STUDY Histological preparation of a section of the vaginal mucosa stained with haematoxylin and eosin (H&E). (A): Vaginal mucosa in the basal condition. It is possible to see a thinner epithelium. (B):...

 Open the catalog to page 7
SmartXide2  V2LR-8

TECHNICAL DATA SMARTXIDE2 - Suggested Configurations in V2LR C40 Laser Type Emission Beam Emission Modes Emission Time Delay Emission Time Beam Delivery 7 Mirrors articulated arm with counterweight. Aiming Beam Laser diode @ 635 nm - 4 mW - Adjustable intensity from 2% to 100% - Aiming light OFF or Diode Off While Lasing (DOWL). About 150 factory stored protocols, upgradable by USB. Possibility of storing unlimited number of custom user’s protocols. Internal Database Control Panel Wide LCD Colour Touch Screen (10.4”) HiScan V2LR Scanner System. Wide range of surgical handpieces. Electrical Requirements...

 Open the catalog to page 8

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*Prices are pre-tax. They exclude delivery charges and customs duties and do not include additional charges for installation or activation options. Prices are indicative only and may vary by country, with changes to the cost of raw materials and exchange rates.