InMode VOTIVA User manual

Operator Manual

Votiva Operator Manual DO607094B 2
Votiva System
Operator Manual
DO607094B
Copyright © InModeMD Ltd,
Date: October, 2017
All rights reserved. Contents of this publication may not be reproduced in any form
without the written permission of InMode MD Ltd.
MInMode MD Ltd
Tabor House, Industrial Park South
Yokneam 2069201, POB 44, Israel
For information call: [phone]

Votiva Operator Manual DO607094B 3
Table of Contents
SECTION 1 –INTRODUCTION ................................................................................................................5
BEFORE YOU START................................................................................................................................... 5
SYSTEM OVERVIEW.................................................................................................................................... 5
CONVENTIONS USED IN THE MANUAL........................................................................................................ 6
EXPLANATION OF THE SYMBOLS USED ON THE SYSTEM............................................................................. 7
SECTION 2 –SAFETY ................................................................................................................................8
THE PATIENT.............................................................................................................................................. 8
TREATING ATTENDANT .............................................................................................................................. 8
CAUTIONS................................................................................................................................................... 9
ELECTRICAL AND MECHANICAL SAFETY.................................................................................................... 9
FIRE HAZARDS ........................................................................................................................................... 9
SAFETY FEATURES OF THE SYSTEM............................................................................................................ 9
SAFE USE OF THE ACTIVE ACCESSORIES ...................................................................................................10
WARNINGS ................................................................................................................................................11
DEVICE LABELS.........................................................................................................................................12
HANDPIECE LABELS...................................................................................................................................13
EQUIPMENT CLASSIFICATION ....................................................................................................................14
SECTION 3 - SYSTEM INSTALLATION...............................................................................................15
ELECTRICAL REQUIREMENTS ....................................................................................................................15
ENVIRONMENTAL REQUIREMENTS ............................................................................................................15
EQUIPMENT LIST .......................................................................................................................................15
UNPACKING...............................................................................................................................................16
INSTALLATION...........................................................................................................................................17
MOVING THE SYSTEM................................................................................................................................17
DISPOSAL OF SYSTEM................................................................................................................................17
SECTION 4 - DESCRIPTION OF DEVICE............................................................................................18
REAR PANEL..............................................................................................................................................18
FRONT PANEL AND OPERATOR CONTROL PANEL ......................................................................................18
SOFTWARE SCREENS .................................................................................................................................20
SOUND INDICATOR ....................................................................................................................................26
CUT-OFF TEMPERATURE CONTROL...........................................................................................................26
HANDPIECES..............................................................................................................................................26
SECTION 5 - SYSTEM OPERATION .....................................................................................................29
DEVICE START-UP.....................................................................................................................................29
SYSTEM SHUTDOWN..................................................................................................................................29

Votiva Operator Manual DO607094B 4
SECTION 6 - FORMAV TREATMENT INFORMATION....................................................................30
INDICATIONS FOR USE...............................................................................................................................30
CONTRAINDICATIONS ................................................................................................................................30
POSSIBLE ADVERSE EFFECTS ....................................................................................................................32
HANDPIECE CLEANING INSTRUCTION PRIOR TO USE.................................................................................32
PRE-TREATMENT RECOMMENDATIONS .....................................................................................................33
TREATMENT RECOMMENDATIONS.............................................................................................................33
TREATMENT SCHEDULE.............................................................................................................................35
POST-TREATMENT RECOMMENDATIONS ...................................................................................................35
SECTION 7 –FRACTORA/FRACTORAV TREATMENT INFORMATION.......................................36
FRACTIONAL SKIN RESURFACING............................................................................................................36
INDICATIONS FOR USE..............................................................................................................................36
CONTRAINDICATIONS................................................................................................................................36
POSSIBLE ADVERSE EFFECTS .................................................................................................................37
PRE-TREATMENT RECOMMENDATIONS ...................................................................................................38
TIP CLEANING INSTRUCTIONS PRIOR TO USE .........................................................................................39
TEST SPOTS .............................................................................................................................................39
TREATMENT RECOMMENDATIONS............................................................................................................40
TREATMENT SCHEDULE............................................................................................................................41
POST-TREATMENT RECOMMENDATIONS .................................................................................................42
SECTION 8 –SYSTEM MAINTENANCE ..............................................................................................43
MAINTENANCE &FREQUENCY .................................................................................................................43
BEFORE AND AFTER EACH TREATMENT....................................................................................................43
ONCE A WEEK ..........................................................................................................................................43
ONCE A YEAR............................................................................................................................................43
SECTION 9 –TROUBLESHOOTING.....................................................................................................44
DESCRIPTION OF FAULTS...........................................................................................................................44
SECTION 10 - SYSTEM SPECIFICATIONS..........................................................................................45
OUTPUT POWER CURVES...........................................................................................................................46
EMC SAFETY ............................................................................................................................................47
TABLE FROM IEC60601-1-2, /5.2.2.1 C&F............................................................................................51

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.

Votiva Operator Manual DO607094B 6
Conventions Used in the Manual
The following conventions in the form of notes and warnings are used in this manual:
Provides general information that is important to keep in mind.
WARNING! This information is extremely important!
ATTENTION! Consult Accompanying Document.

Votiva Operator Manual DO607094B 7
Explanation of the Symbols used on the System
Symbol
Description
CSA marking (212603 CSA master contract number)
Do not discard in trash. Electronic equipment should be
disposed of in an appropriate manner.
Fuse
Type BF Equipment
Type B Equipment.
HF Isolated Patient Circuit
This equipment intentionally supplies non-ionizing RF
energy
Follow instructions for use
Federal (US) law restricts this device to sale by the order
of a physician licensed by the law of the state in which he
practiced to use or order the use of the device

Votiva Operator Manual DO607094B 8
Section 2 – Safety
This chapter describes safety issues regarding the use and maintenance of the System,
with a special emphasis on electrical safety.
The System is designed for safe and reliable treatment when used in accordance with
proper operation and maintenance procedures. Only trained, qualified practitioners can
use the System. The operator and all other personnel operating or maintaining the System
should be familiar with the safety information provided in this Section.
The primary consideration should be to maximize safety for both treating attendant and
patient.
•Read this chapter to be familiar with all its safety requirements
and operating procedures prior to System operation.
•RF energy can cause injury if used improperly.
•High voltage is present inside the System.
•Always be aware of the possible dangers and take proper
safeguards as described in the manual.
The Patient
Well-trained staff is key for assuring patient safety. A patient history should be completed
prior to scheduling treatment. Patients should be fully informed of the treatment protocol,
the likely results and any risks associated with the treatment.
Patients should not be in contact with any metal or other alternate pathway to the ground,
while system in use.
Metal jewelry and metal accessories that are within the activation range of the Handpiece
should be removed to avoid accidental RF conduction.
Treating Attendant
Only authorized individuals with appropriate training and knowledge should operate,
assist in the operation of, or provide maintenance to the System.
Personnel should not operate the System until they have been fully educated in its use.
Make sure that all treatment personnel are familiar with the System controls and know
how to shut down the System instantly.
There are no user-serviceable parts in the system, and all service and repair must be
performed only by the factory or authorized field service technicians.

Votiva Operator Manual DO607094B 9
Cautions
The following cautions should be heeded for safe System use:
•Do not touch the System’s inner parts.
•Service is supplied by company-authorized personal only.
•To avoid damage, do not allow the Handpiece to come in contact with hard
materials.
Electrical and Mechanical Safety
•Keep all covers and panels of the System closed. Removing the covers creates a
safety hazard.
•Keep hands away from the applicator during the System start-up.
•Perform maintenance procedures when the System is shut down and disconnected
from the power.
•The System is grounded through the grounding conductor in the power cable. This
protective grounding is essential for safe operation.
•Provide as much distance as possible between the system and other electronic
equipment as the activated RF generator may cause interference between them.
•Move the System slowly and carefully. The System weighs approximately 20kg
(44lb.) and may cause injury if proper care is not used when moving it.
Fire Hazards
•Materials conducting RF energy may cause temperature rise of the absorbing
material. Do not use the System in the presence of explosive or flammable
materials conductive to RF.
•Do not use flammable substances when preparing the skin for treatment. Be
especially careful with the use of oxygen.
•If alcohol is used for cleaning and disinfecting, it must be allowed to dry
thoroughly before the System is used.
Safety Features of the System
The System incorporates the following safety features. All personnel operating the
System should be familiar with these features:
•System has unique password to avoid device operation by non-authorized
personnel.

Votiva Operator Manual DO607094B 10
•The power electronics cannot be activated unless the applicator and footswitch has
been connected to the System.
•An audible tone indicates energy activation.
•During activation, the System performs a self-test of the hardware.
•Hardware is tested every 10msec to ensure proper operation of electrical circuit.
•System starts at a low power setting.
•Skin surface temperature monitoring.
Safe Use of the Active Accessories
•Examine the connection of the Handpiece through the connectors to the System
before using. Ensure that the accessory functions as intended. Improper
connection may result in arcs and sparks, accessory malfunction, or unintended
treatment effects.
•Do not wrap the Handpiece cords around metal objects. It may induce current that
could lead to electrical shocks, fire or injury to the patient or personnel.
•Ensure that electrodes are in full contact with the skin. Bad coupling of both
electrodes with the skin results in a specific warning sound, a message on the
screen, and disabling of RF.
•Do not connect a wet accessory to the System.
•Do not immerse the applicator under water at any time.

Votiva Operator Manual DO607094B 11
Warnings
This equipment is for use only by trained, licensed physicians.
Only handpieces manufactured or approved by InMode MD Ltd. should be used with
System.
Connect the power cord to a properly polarized and grounded power source with the
frequency and voltage characteristics that match those listed on the back of the unit.
Connect the power cord to a properly grounded receptacle. Do not use power plug
adapters.
Always turn off and unplug the System before cleaning.
The PATIENT should not come into contact with metal parts which are earthed or
which have an appreciable capacitance to earth. The use of antistatic sheeting is
recommended for this purpose. Treatment bed or chair should not be electric!
Failure of the equipment could result in an unintended increase of output power.
Use the lowest output setting necessary to achieve the desired treatment effect. The
higher RF energy is applied, the greater the possibility of unintended thermal damage of
skin.
The cables of the handpiece should be positioned in such a way that contact with the
PATIENT or other leads is avoided.
Fire / Explosion Hazard - The following substances will contribute to increased fire and
explosion hazards in the operating room:
• Flammable substances (such as alcohol based skin prepping agents and tinctures)
• Naturally occurring flammable gases which may accumulate in body cavities such
as the bowel
• Oxygen enriched atmospheres
• Oxidizing agents (such as nitrous oxide [N2O] atmospheres).
• Endogenous gases.
The RF energy and heating associated with the System can provide an ignition source.
Observe fire precautions at all times. When using System in the same room with any of
these substances or gases, prevent their accumulation or pooling within the area where
System procedures are performed.
The operation of the System may adversely influence the operation of other electronic
EQUIPMENT.
To avoid the RISK of electric shock, this equipment must only be connected to a
SUPPLY MAINS with protective earth

Votiva Operator Manual DO607094B 12
Device Labels
As required by national and international regulatory agencies, appropriate warning and
information labels have been attached in specific locations on the instrument as identified
below:
Figure 2.1 System certification and identification label
Figure 2.2 Footswitch label

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Handpiece labels
The Handpieces certification and identification labels are attached to connectors on the
Handpieces. It states that the product conforms to the performance standards, and
indicates the manufacturer’s name, date of manufacturing, model and serial number of the
Handpiece.
The following labels are located on the Handpieces:
Manufacturer identification labeling is placed on the hand pieces.
Figure 2.3 The Plus90 (FormaV) Handpiece label
Figure 2.4 The FRACTORA Handpiece label

Votiva Operator Manual DO607094B 14
Equipment Classification
The following is a list of the different equipment used and their classifications:
•Electric shock protection: Class I, Defibrillation-proof Type BF
•Protection against ingress of liquids: Ordinary equipment
•Not suitable for use in presence of flammable substance
•Power receptacle must include protective earth, and must be checked before
connecting the system.
The Votiva system with the Handpieces is classified as class II device by CDRH.

Votiva Operator Manual DO607094B 15
Section 3 - System Installation
Electrical Requirements
•The System will require a separate line supply of single phase (100Vac; 15A) or
(115Vac; 15A) or (230Vac; 15A) or (240Vac; 15A) 50-60Hz. Zmax = 0.03Ω.
•Power receptacles must be within 15 feet of the System site.
•The System should not share a power line with other equipment.
•Power receptacle must include protective earth, and must be checked before
connecting the system
•For continued protection against fire, replace the fuse only with
one of the same type and rating.
•Proper grounding is essential for safe operation.
Environmental Requirements
•Corrosive materials can damage electronic parts; therefore, the System should
operate in a non-corrosive atmosphere.
•For optimal operation of the System, maintain room temperature between
20º-27ºC (68º-79ºF) and relative humidity of less than 80%.
Equipment List
The System includes the following:
•System platform
•Handpieces
•Handpieces cradles
•Footswitch
•Operator manual
•Power cord

Votiva Operator Manual DO607094B 16
Unpacking
In order to unpack the device:
1. Remove the paper strip and open the box
2. Remove accessories and foams around the device.
3. Take device out of the box using top and bottom handles.

Votiva Operator Manual DO607094B 17
Installation
To install the System, perform the following tasks:
•Check the System and all its components for damage.
•Connect Cradle to the System.
•Connect Handpiece to the connector.
•Place Handpiece into the cradle.
•Connect Footswitch to the footswitch connector.
•Connect the Power Cord to the System inlet.
•Plug the System Power Cord into an appropriate electrical outlet.
Moving the System
To move the System:
•Turn the System off.
•Disconnect the Power Cord.
•Disconnect the Handpieces.
•Disconnect the Footswitch.
•Release the wheel brakes.
•Slowly push or pull the System using the handle.
•When moving to another facility, lift the System to the vehicle and lay it carefully
on its side.
•Never lift, pull or push the System using the operating panel.
•Always use handles when moving or lifting the System.
•Upon unpacking check the System for mechanical damage (e.g.,
cracks in the cable insulation).
Disposal of System
To comply with European Commission Directive 2002/96/EC on Waste Electrical and
Electronic Equipment (WEEE) and other country and state regulations, please DO NOT
dispose of this equipment in any location other than designated locations.

Votiva Operator Manual DO607094B 18
Section 4 - Description of Device
Rear Panel
Power cord inlet
100-240V~, 12A, 50-60Hz.
Fuse holder
Rating is T 15A, 250V SB. Replace fuse if it is needed only with fuses having
exactly the same rating.
Software flash memory plug
Software plug is a flash memory with the machine software. The software plug
should be screwed to the connectors.
Foot switch connector
Foot switch is connected to the inlet. Foot switch activates RF energy if the
system is in Ready mode. Place the foot switch on the floor near the treatment
area.
RF
Handpiece
Connector
Located on the upper right side of the front panel.
.
Front Panel and Operator Control Panel
The Operator Control Panel is located on the upper side of the System. The Operator
Control Panel consists of an LCD touch screen.
!!


Votiva Operator Manual DO607094B 19
Figure 4.1 Handpiece connectors on front panel
Power On-Off switch
Power switch turns power electronics On and Off
LCD screen
LCD screen shows information about system mode and
treatment parameters.
The panel allows changing treatment parameters and
system mode.
Power electronics is not activated if Handpiece is not connected to its connector on the
front panel.

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Software Screens
The Splash screen appears after the On-Off switch is turned on.
Figure 4.2 Splash Screen
*The version number will be displayed according to the software version.
After entering the individual code in the Login Screen, non-authorized use of the device
is prevented.
Figure 4.3 Login Screen