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General| Handpieces | FormaV, FractoraV, Aviva |
|---|---|
| RF Frequency | 1 MHz |
| FDA Cleared | Yes |
| Applications | Vaginal rejuvenation, treatment of vaginal laxity, stress urinary incontinence |
| FormaV | Designed for vaginal rejuvenation and tightening |
| FractoraV | Designed for fractional RF treatment of vaginal mucosa |
| Aviva | Minimally invasive radiofrequency handpiece for labiaplasty and vaginal tightening |
| Treatment Areas | Vaginal canal, labia |
| Energy Source | Radiofrequency |
| Treatment Duration | Approximately 30 minutes per session |
| Number of Treatments | 3 treatments |
| Downtime | Minimal |
Manual and equipment are for qualified medical professionals. Safety requirements must be read.
Describes Votiva System with FormaV and FRACTORA Handpieces for aesthetic applications.
Emphasizes well-trained staff, patient history, and informing patients about the protocol.
Outlines requirements for authorized, trained personnel and no user-serviceable parts.
Consolidates cautions, electrical, mechanical, and fire safety measures for the system.
Details safety features and guidelines for the safe use of system accessories.
Lists warnings about physician use, handpieces, power connection, and cleaning.
Details substances contributing to fire hazards and RF energy as an ignition source.
Warns about potential adverse influence on other electronic equipment and shock risk.
Describes the main system certification and identification label with model, SN, and power details.
Identifies the label present on the footswitch of the system.
Details the certification and identification label for the Plus90 (FormaV) handpiece.
Describes the certification and identification label for the FRACTORA handpiece.
Lists classifications for electric shock protection, liquid ingress, and suitability for flammable substances.
Specifies power supply, receptacles, grounding, and fuse replacement for system installation.
Details optimal room temperature, humidity, and non-corrosive atmosphere for operation.
Lists the components included with the Votiva System.
Provides step-by-step instructions for unpacking the Votiva system.
Outlines installation tasks, safe moving procedures, and disposal advice.
Describes the power cord inlet, fuse holder, software plug, and foot switch connector.
Details the location and function of the operator control panel and touch screen.
Illustrates handpiece connectors and explains power switch and LCD screen functions.
Explains the initial splash screen and the login screen for device access.
Describes the menu screen for handpiece selection and the utilities screen for system settings.
Details the FormaV treatment screen for adjusting energy, cut-off, and pulse mode.
Explains the FRACTORA treatment screen for tip type, energy, pulse mode, and counter reset.
Details the FractoraV treatment screen for tip type, energy, pulse mode, and counter reset.
Explains pulse mode options and the three system modes: Standby, Ready, and Active.
Describes sound signals for RF delivery and cut-off temperature control for safety.
Details the components of the FormaV Handpiece: tip, handle, cable, and connector.
Describes the components of the FRACTORA Handpiece and its usage.
Explains the different pin array sizes for FRACTORA tips and their usage.
Provides a step-by-step guide to start and prepare the Votiva system for operation.
Explains the correct procedure for shutting down the Votiva system.
Lists the intended therapeutic uses of the Votiva System with FormaV Handpiece.
Details conditions that prevent the use of the Votiva System with FormaV Handpiece.
Lists additional contraindications related to immune system, skin conditions, and medications.
Lists potential side effects experienced during or after FormaV treatment.
Provides validated procedures for cleaning the Handpiece with 70% alcohol.
Outlines essential recommendations for patients before FormaV treatment.
Provides guidelines for setting energy levels, gel application, and treatment parameters.
Details temperature cut-off, power level, positioning, and treatment execution.
Suggests the typical number and frequency of FormaV treatment sessions.
Advises patients on post-treatment care, including cooling, cleaning, and avoiding certain activities.
Explains how FRACTORA delivers RF energy for skin resurfacing and heating.
Lists dermatological procedures requiring ablation and resurfacing using FRACTORA.
Details contraindications for FRACTORA, including implants, cancer history, and pregnancy.
Lists additional contraindications for FRACTORA, including skin conditions and prior treatments.
Lists potential adverse effects of FRACTORA treatment such as pain, redness, and scarring.
Outlines steps for attendants, patient assessment, and advice on sun exposure and skin preparation.
Provides instructions for cleaning FRACTORA tips with 70% alcohol.
Details the steam autoclave sterilization process for disposable handpieces.
Explains the importance and process of performing test spots before treatment.
Guides on anesthesia, skin preparation, energy levels, and tip usage for FRACTORA.
Suggests treatment session frequency, duration, and follow-up for FRACTORA.
Advises on post-treatment care, including cooling, creams, sunscreen, and managing potential effects.
Covers frequency and procedures for maintenance: before/after treatment, weekly, and yearly.
Lists common faults like system not turning on, software issues, and handpiece connection errors.
Details input power, operating/storage parameters, dimensions, weight, and RF specs.
Presents graphical data on output power versus impedance for different modes.
Explains compliance with IEC 60601-1-2 and measures to avoid interference.
Declares compliance with RF emissions standards and guidance for electromagnetic environment.
Details immunity tests (ESD, EFT, Surge) and compliance levels for electromagnetic environment.
Provides guidance on conducted and radiated RF immunity and recommended separation distances.
Lists recommended separation distances for RF communications equipment based on transmitter power.
Summarizes test results for emissions, immunity, and compliance with IEC standards.
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