Votiva Operator Manual DO607094B 5
Section 1 – Introduction
Before You Start
The manual and the equipment it describes are for use only by qualified medical
professionals trained in the particular technique to be performed.
Federal (USA) law restricts sale of this device by or on the order of a physician.
Read this manual to become familiar with all safety requirements and operating
procedures before attempting to operate the System.
System Overview
The InModeRF Platform with FRACTORA and FormaV (Plus90) Handpieces is
marketed as the Votiva System which employs Radio-frequency (RF) technologies for
various aesthetic applications.
The Votiva System with FormaV Handpiece is a genital device for therapeutic use, an
electrically operated device intended and labeled for therapeutic use in the treatment of
sexual disfunction or as an adjunct to Kegel’s exercise (tightening of the muscles of the
pelvic floor to increase muscle tone). It is also intended for treatment of selected medical
conditions such as relief of minor muscle aches and pain, relief of muscle spasm,
temporary improvement of local blood circulation.
The Votiva System with FRACTORA Handpiece is used in dermatologic procedures
requiring ablation and resurfacing of the skin. It is also intended for use in dermatologic
and general surgical procedures for electrocoagulation and hemostasis. At higher energy
levels greater than 62 energy levels, use of the applicator is limited to Skin Types I-IV.
The System provides individual adjustment of RF power to achieve maximum efficiency,
safety and comfort for each patient. The System provides enhanced safety while
minimizing possible side effects by monitoring RF parameters.
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