InMode MD CONTOURA User manual

Operator Manual
CONTOURA SYSTEM
DO607093A

CONTOURA Operator Manual 2
CONTOURA System
Operator Manual
DO607093A
Copyright © InMode MD Ltd,
Date: August, 2016
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
POB 44, Yokneam 2069201, Israel
For information call: [phone]

CONTOURA Operator Manual 3
Table of Contents
SECTION 1 –INTRODUCTION ................................................................................................................5
BEFORE YOU START................................................................................................................................... 5
SYSTEM OVERVIEW.................................................................................................................................... 5
CONVENTIONS USED IN THE MANUAL........................................................................................................ 5
EXPLANATION OF THE SYMBOLS USED ON THE SYSTEM............................................................................. 6
SECTION 2 –SAFETY ................................................................................................................................7
THE PATIENT.............................................................................................................................................. 7
TREATING ATTENDANT .............................................................................................................................. 7
CAUTIONS................................................................................................................................................... 8
ELECTRICAL AND MECHANICAL SAFETY.................................................................................................... 8
FIRE HAZARDS ........................................................................................................................................... 8
SAFETY OPERATIONAL USE OF THE SYSTEM .............................................................................................. 8
SAFE USE OF THE ACTIVE ACCESSORY....................................................................................................... 9
WARNINGS ................................................................................................................................................10
DEVICE LABELS.........................................................................................................................................11
HANDPIECE LABELS...................................................................................................................................11
..................................................................................................................................................................13
..................................................................................................................................................................13
..................................................................................................................................................................13
EQUIPMENT CLASSIFICATION ....................................................................................................................14
SECTION 3 - SYSTEM INSTALLATION...............................................................................................15
ELECTRICAL REQUIREMENTS ....................................................................................................................15
ENVIRONMENTAL REQUIREMENTS ............................................................................................................15
EQUIPMENT LIST .......................................................................................................................................15
UNPACKAGING ..........................................................................................................................................16
INSTALLATION...........................................................................................................................................16
MOVING THE SYSTEM................................................................................................................................16
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 ....................................................................................................................................25
CUT-OFF TEMPERATURE CONTROL...........................................................................................................25
HANDPIECE................................................................................................................................................26
SECTION 5 - SYSTEM OPERATION .....................................................................................................29
DEVICE START-UP.....................................................................................................................................29

CONTOURA Operator Manual 4
SYSTEM SHUTDOWN..................................................................................................................................29
SECTION 6 - TREATMENT INFORMATION BODYFX/MINIFX.....................................................30
INDICATIONS FOR USE...............................................................................................................................30
CONTRAINDICATIONS................................................................................................................................30
POSSIBLE ADVERSE EFFECTS ....................................................................................................................31
HANDPIECE CLEANING INSTRUCTION PRIOR TO USE.................................................................................31
PRE-TREATMENT RECOMMENDATIONS .....................................................................................................32
TREATMENT RECOMMENDATIONS.............................................................................................................33
TREATMENT SCHEDULE.............................................................................................................................34
POST-TREATMENT RECOMMENDATIONS ...................................................................................................34
SECTION 7 - TREATMENT INFORMATION FORMA-PLUS...........................................................36
INDICATIONS FOR USE...............................................................................................................................36
CONTRAINDICATIONS ................................................................................................................................36
POSSIBLE ADVERSE EFFECTS ....................................................................................................................37
HANDPIECE CLEANING INSTRUCTION PRIOR TO USE.................................................................................37
PRE-TREATMENT RECOMMENDATIONS .....................................................................................................38
TREATMENT RECOMMENDATIONS.............................................................................................................39
TREATMENT SCHEDULE.............................................................................................................................40
POST-TREATMENT RECOMMENDATIONS ...................................................................................................41
SECTION 8–SYSTEM MAINTENANCE ...............................................................................................42
MAINTENANCE &FREQUENCY .................................................................................................................42
BEFORE AND AFTER EACH TREATMENT....................................................................................................42
ONCE A WEEK ..........................................................................................................................................42
ONCE A YEAR............................................................................................................................................42
SECTION 8 –TROUBLESHOOTING.....................................................................................................43
DESCRIPTION OF FAULTS WITH ALL HANDPIECES.....................................................................................43
SECTION 13 - SYSTEM SPECIFICATIONS..........................................................................................44
RF OUTPUT POWER CURVES .....................................................................................................................45
EMC SAFETY FOR THE RF DEVICE............................................................................................................45

CONTOURA Operator Manual 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 to 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 CONTOURA System based on InmodeRF platform is a medical aesthetic device
combining mechanical vacuum skin massaging and non-thermal RF energy for the
treatment of selected medical conditions such as relief of minor muscle aches and pain,
relief of muscle spasm, temporary improvement of local blood circulation, and temporary
reduction in the appearance of cellulite.
The System provides individual adjustment of vacuum pulse parameters and non-thermal
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.
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.

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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
HF Isolated Patient Circuit
This equipment intentionally supplies non-ionizing RF
energy
Follow operating instructions
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.

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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 a key for assuring patient safety. A patient history should be
completed prior to scheduling. 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 is 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 laser 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.

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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 personnel 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 32kg
and may cause injury if proper care is not used when moving it.
Fire Hazards
Materials conducting RF energy cause temperature rise of the absorbing material.
Do not use the System in the presence of explosive or flammable materials
conductive to RF.
Keep drapes and towels moist to prevent them from igniting and burning as a
result of misuse. Use non-flammable prepping solutions.
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 Operational Use 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.

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The power electronics cannot be activated unless the applicator 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.
Vacuum level monitoring. RF is disabled when vacuum is below the
predetermined level.
Skin temperature monitoring.
Safe Use of the Active Accessory
Examine the connection of Handpiece and 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 personal.
Ensure that electrodes are in full contact with the skin.
Bad coupling of both electrodes with the skin result 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.

CONTOURA Operator Manual 10
Warnings
This equipment is for use only by trained, licensed physicians.
Only Handpieces manufactured or approved by InMode MD Ltd. should be used with
CONTOURA 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 CONTOURA 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 CONTOURA in the same room with
any of these substances or gases, prevent their accumulation or pooling within the
area where CONTOURA procedures are performed.
The operation of the CONTOURA 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.

CONTOURA Operator Manual 11
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.
The following device labels are located on CONTOURA device console:
Figure 2.1 System certification and identification label
Figure 2.2 Footswitch label
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

CONTOURA Operator Manual 12
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 BodyFX Handpiece label

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Figure 2.4 The MiniFX Handpiece label
Figure 2.5 The FORMA-PLUS Handpiece label

CONTOURA Operator Manual 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 System with the BodyFX/MiniFX/FORMA PLUS Handpieces is classified as class II
device by FDA.

CONTOURA Operator Manual 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
BodyFX Handpiece
MiniFX Handpiece
FORMA PLUS Handpiece
Handpieces cradles
Foot switch
Operator manual
Power cord

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

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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.

CONTOURA Operator Manual 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 non-thermal 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 front top side of the rear panel and connects to the Handpiece.
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 screen and four buttons.
!!


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Figure 4.1 Handpiece connectors on front panel
Power On-Off switch
Power switch turns power electronics On and Off
Emergency Stop Button
Stops the power instantly in emergency conditions
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 no Handpiece is connected to its connector on the
front or the rear panel. The system recognizes the connected handpiece and enables
opening the relevant screen.

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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.
Non-authorized use of the device is prevented by entering the individual code on the
Login screen.
Figure 4.3 Login Screen
Software is loaded from the plug and self-test of the System module is performed. After
the end of the self-test, the Menu Screen appears.