InMode InMode System with BodyFX Handpiece User manual

Operator Manual
InMode™ SYSTEM With
BodyFX™ Handpiece
DO602777B

InMode BodyFX Operator Manual 2

InMode BodyFX Operator Manual 3
InMode™ System with BodyFX™ Handpiece
Operator Manual
DO602777B
Copyright © InMODE MD Ltd,
Date: December, 2013
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]

InMode BodyFX Operator Manual 4
Table of Contents
SECTION 1 –INTRODUCTION.....................................................................................................................6
BEFORE YOU START.......................................................................................................................................... 6
SYSTEM OVERVIEW .......................................................................................................................................... 6
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 OPERATIONAL USE OF THE SYSTEM......................................................................................................... 10
ACTIVE ACCESSORY ........................................................................................................................................ 10
WARNINGS................................................................................................................................................... 11
DEVICE LABELS .............................................................................................................................................. 12
HANDPIECE LABELS......................................................................................................................................... 14
EQUIPMENT CLASSIFICATION............................................................................................................................ 14
SECTION 3 - SYSTEM INSTALLATION........................................................................................................15
ELECTRICAL REQUIREMENTS............................................................................................................................. 15
ENVIRONMENTAL REQUIREMENTS..................................................................................................................... 15
EQUIPMENT LIST ........................................................................................................................................... 15
UNPACKAGING .............................................................................................................................................. 16
INSTALLATION ............................................................................................................................................... 17
FIGURE 3.1 CRADLE CONNECTIONS TO THE DEVICE................................................................................... 17
MOVING THE SYSTEM..................................................................................................................................... 17
DISPOSAL OF SYSTEM ..................................................................................................................................... 18
SECTION 4 - DESCRIPTION OF DEVICE......................................................................................................19
REAR PANEL ................................................................................................................................................. 19
FRONT PANEL AND OPERATOR CONTROL PANEL .................................................................................................. 20
SOFTWARE SCREENS....................................................................................................................................... 21
FUNCTIONAL KEYS ......................................................................................................................................... 25
SOUND INDICATOR......................................................................................................................................... 25
CUT-OFF TEMPERATURE CONTROL ................................................................................................................... 25
HANDPIECE................................................................................................................................................... 26
SECTION 5 - SYSTEM OPERATION ............................................................................................................27
DEVICE START-UP.......................................................................................................................................... 27
SYSTEM SHUTDOWN ...................................................................................................................................... 27
SECTION 6 - TREATMENT INFORMATION ................................................................................................28
INDICATIONS FOR USE .................................................................................................................................... 28
CONTRAINDICATIONS...................................................................................................................................... 28
POSSIBLE ADVERSE EFFECTS............................................................................................................................. 29
HANDPIECE CLEANING INSTRUCTION PRIOR TO USE.............................................................................................. 29
PRE-TREATMENT RECOMMENDATIONS .............................................................................................................. 30
TREATMENT RECOMMENDATIONS..................................................................................................................... 30
TREATMENT SCHEDULE ................................................................................................................................... 31
POST-TREATMENT RECOMMENDATIONS ............................................................................................................ 31
SECTION 7–SYSTEM MAINTENANCE .......................................................................................................33

InMode BodyFX Operator Manual 5
EXTERNAL VALIDATION MODULE ...................................................................................................................... 33
FILLING /DRAINING WATER ............................................................................................................................ 33
CLEANING THE DEVICE .................................................................................................................................... 34
SECTION 8 –TROUBLESHOOTING............................................................................................................35
DESCRIPTION OF FAULTS WITH ALL HANDPIECES .................................................................................................. 35
SECTION 9 - SYSTEM SPECIFICATIONS .....................................................................................................37
OUTPUT POWER CURVES ................................................................................................................................ 38
EMC SAFETY FOR THE INMODE DEVICE ............................................................................................................. 39
TABLE FROM IEC60601-1-2, /5.2.2.1 C&F..................................................................................................... 43

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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 InMode System with the BodyFX Handpiece 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.
RF energy does not cause any thermal damage to the treated skin and adipose tissue.
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!

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Explanation of the Symbols used on the System
Symbol
Description
Warning!
Attention! Consult Accompanying Document
CSA marking (212603 CSA master contract number)
CE marking
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 instructions for use
Note

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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 chapter.
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.
Skin massaging may cause bruising and skin damage if used
improperly
RF devices 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 the system is in use. Metal jewelry should be removed if it is within the activation
range of the Handpiece.
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.

InMode BodyFX Operator Manual 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 because the activated RF generator may cause interference between
them.
Move the System slowly and carefully. The System weighs approximately 30kg
(66lb.) and may cause injury if proper care is not used when moving it.
Fire Hazards
The conducted RF energy may raise the temperature of the material if misused.
Do not use the System in the presence of explosive or flammable materials.
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.

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Safety Operational Use of the System
The System incorporates the following safety features. All personnel operating the
System should be familiar with these features.
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 periodically 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.
Active Accessory
Examine the 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.
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 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.
Do not connect a wet accessory to the System.
Do not immerse the applicator under water at any time.

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Warnings
This equipment is for use only by trained, licensed physicians.
Only Handpieces manufactured or approved by InMode MD Ltd. should be used with
InMode 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 InMode 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 effect. Use the RF energy only
for the minimum time necessary in order to lessen the possibility of unintended burn injury.
The higher the RF energy and the longer the RF energy is applied, the greater the
possibility of unintended thermal damage to tissue.
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 sparking and heating associated with InMode can provide an ignition source. Observe
fire precautions at all times. When using InMode in the same room with any of these
substances or gases, prevent their accumulation or pooling within the area where
InMode procedures are performed.
The operation of the InMode 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.

InMode BodyFX Operator Manual 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.
The following device labels are located on InMode device console:
Figure 2.1 Manufacturer System Identification Label

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Figure 2.2 USA Federal Restriction Notice
Figure 2.3 System RF output label
Figure 2.4 Footswitch Label.

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Handpiece labels
Manufacturer identification labeling is placed on the InMode BodyFX Handpiece:
Figure 2.4 The InMode BodyFX Handpiece Label
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.
System is classified as an IIb device defined by the Medical Device Directive
(93/42/EEC) for CE marking.

InMode BodyFX 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.
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
BodyFX Handpiece cradle
Foot switch
Operator manual
Power cord

InMode BodyFX Operator Manual 16
Unpackaging
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.

InMode BodyFX Operator Manual 17
Installation
To install the System perform the following tasks:
Check the System and all its components for damage.
Add water. Use the Maintenance Screen.
Connect Footswitch to the footswitch connector.
Connect the Power Cord to the System inlet.
Plug the System Power Cord into an appropriate electrical outlet.
Connect Cradle to the System (Fig. 3.1).
Connect Handpiece to top right inlet at rear panel (Fig 4.1).
Place Handpiece into the cradle.
Figure 3.1 Cradle connections to the device
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.

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Never lift, pull or push the System using the operating panel.
Always use handles moving or lifting the System.
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.

InMode BodyFX Operator Manual 19
Section 4 - Description of Device
Rear Panel
!!
Power cord inlet
100-240V~, 2A, 50-60Hz.
Fuse holder
Rating is T 2A, 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 upper right side of the rear panel and connects to the Handpiece.
Figure 4.1 RF connector on rear panel (arrow)

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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.
Figure 4.2 Front Panel and Operator Control Panel
Power On-Off switch Power switch turns power electronics off.
Emergency Stop Stops the power instantly in emergency conditions.
Button
LCD screen LCD screen shows information about system mode and treatment parameters.
The panel allows changing treatment parameters and system mode.