InMode BodyTite User manual

BodyTite
InMode RF
Operator Manual
Version: DO607095B

Operator Manual: BodyTite™ System DO607095B
Copyright © InMode MD 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.
🏭InMode MD Ltd.
Tabor House, Industrial Park South
POB 44, Yokneam 2069201, Israel
For information call: [phone]

Contents
Section 1: Introduction ........................................................................................... 1
1.1 Before You Start........................................................................................................... 1
1.2 System Overview.......................................................................................................... 1
1.3 Conventions used in the Manual ................................................................................. 1
1.4 Explanation of the Symbols Used on the System......................................................... 1
Section 2: Safety ..................................................................................................... 3
2.1 The Patient................................................................................................................... 3
2.2 Treating Attendant....................................................................................................... 4
2.3 Cautions ....................................................................................................................... 4
2.4 Electrical and Mechanical Safety ................................................................................. 4
2.5 Fire Hazards.................................................................................................................. 5
2.6 Safety Features of the System ..................................................................................... 5
2.7 Safe Use of the Active Accessories............................................................................... 6
2.8 Warnings ...................................................................................................................... 6
2.9 Device and Handpiece Labels....................................................................................... 8
2.10 Equipment Classification.............................................................................................. 9
Section 3: System Installation ............................................................................... 10
3.1 Electrical Requirements ............................................................................................. 10
3.2 Environmental Requirements .................................................................................... 10
3.3 Equipment List ........................................................................................................... 10
3.4 Unpacking................................................................................................................... 11
3.5 Installation ................................................................................................................. 12
3.6 Moving the System: ................................................................................................... 12
3.7 System Disposal ......................................................................................................... 13
Section 4: Device Description ................................................................................ 14
4.1 Rear Panel .................................................................................................................. 14
4.2 Front Panel and Operator Control Panel ................................................................... 15
4.3 Software Screens........................................................................................................ 15
4.3.1 Sound Indicator ......................................................................................................... 18
4.3.2 External Cut-Off Temperature Control...................................................................... 18
4.3.3 Internal Cut-Off Temperature Control ...................................................................... 18
4.3.4 Treatment Time Control............................................................................................ 18
4.4 Handpieces................................................................................................................. 18

BodyTite Operator Manual
Section 1: Introduction
Section 5: System Operation ................................................................................. 20
5.1 Device Start-Up .......................................................................................................... 20
5.2 System Shutdown ...................................................................................................... 20
Section 6: Treatment Information ......................................................................... 21
6.1 Training Requirements............................................................................................... 21
6.2 Indications for Use ..................................................................................................... 21
6.3 Contraindications....................................................................................................... 21
6.4 Possible Adverse Effects............................................................................................. 22
6.4.1 Gamma sterilized - Instruction Prior to Use.............................................................. 22
6.5 Pre-Treatment Recommendations ............................................................................ 23
6.6 Treatment Recommendations ................................................................................... 23
6.7 Post-Treatment Recommendations........................................................................... 23
System Maintenance ............................................................................................ 24
7.1 Cleaning the Device.................................................................................................... 24
Troubleshooting ................................................................................................... 25
8.1 Description of Faults .................................................................................................. 25
System Specifications............................................................................................ 27
9.1 BodyTite Output Power Curves.................................................................................. 28
9.2 EMC Safety for the BodyTite Device .......................................................................... 29

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Section 1: Introduction
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Section 1: Introduction
This chapter provides a system overview and conventions used in this manual.
1.1 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.
1.2 System Overview
The BodyTite™device is based on the InMode RF™ platform. BodyTite employs
radiofrequency (RF) energy for use in dermatological and general surgical procedures for
electrocoagulation and hemostasis. The System operates when the Handpiece is
connected.
▪The System provides individual adjustment of treatment parameters to achieve
maximum efficiency and safety for the specific treatment.
▪The System provides enhanced safety while minimizing possible side effects by
monitoring RF parameters and tissue temperature.
1.3 Conventions used in the Manual
The following conventions in the form of notes and warnings are used in this manual:
WARNING! This information is extremely important!
ATTENTION! Consult Accompanying Document.
Provides general information that is important to keep in mind.
1.4 Explanation of the Symbols Used on the System

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Section 1: Introduction
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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
Table 1-1: Device Symbols

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Section 2: Safety
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Section 2: Safety
This chapter describes safety issues regarding the use and maintenance of the BodyTite
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 safety requirements and operating
procedures prior to System operation.
The 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 safe-guards as
described in the manual.
2.1 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
details, the likely results and any risks associated with the treatment.
▪Metal jewelry and metal accessories that are within the activation range of the
Handpiece should be removed to avoid accidental RF conduction. The metal item(s)
will be removed prior to use of the equipment.
▪Patients will not be in contact with any metal or other alternate pathway to ground
whilst the System is in use.

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Section 2: Safety
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2.2 Treating Attendant
▪Only authorized individuals with appropriate training and knowledge should operate,
assist in the operation of, or provide maintenance to the BodyTite 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.
2.3 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.
2.4 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 startup.
▪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.
▪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.
▪Provide as much distance as possible between the system, RF Handpiece and other
electronic equipment as the activated RF generator may cause interference between
them.

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Section 2: Safety
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2.5 Fire Hazards
▪Do not use the System in the presence of explosive or flammable materials.
▪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.
▪Keep drapes and towels moist to prevent them from igniting and burning. 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, allow it to dry thoroughly before the
System is used.
2.6 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.
▪The RF energy cannot be activated unless the applicator and footswitch have 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 10ms to ensure proper operation of electrical circuit.
▪Tissue impedance monitoring prevents accidental energy emission to the patient.
▪Skin surface is monitored during the treatment. RF energy delivery is terminated
when skin temperature accidentally reaches the Cut-off level.
▪System starts at a low setting.
▪Internal and skin surface temperature and impedance are constantly monitored.

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Section 2: Safety
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2.7 Safe Use of the Active Accessories
▪Examine the connection of the Handpiece through the connector to the System
before using. 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 shock, fire or injury to the patient or personnel.
▪Ensure that return electrode is in full contact with the skin. Bad coupling of the
return electrode with the skin results in a specific warning sound, a message on the
screen, and disabling of RF.
▪Handpieces are for single use only. Do not try to reuse the handpiece. Re-use of the
handpiece may create loss of integrity of handpiece components that may affect the
performance and make the device non-functional.
Do not connect a wet accessory to the System.
Do not immerse the applicator under water at any time.
The Handpiece is gamma-sterilized for a single use only and CANNOT be
autoclaved or re-sterilized by any other technology.
2.8 Warnings
This equipment is for use only by trained, licensed physicians.
Only Handpieces manufactured or approved by InMode MD Ltd. should be
used with the BodyTite 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 System power cord to a properly grounded receptacle. Do not use
power plug adapters.
Always turn off and unplug the device 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.

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Section 2: Safety
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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.
When BodyTite and physiological monitoring EQUIPMENT are used
simultaneously on the same patient; any monitoring electrodes should be
placed as far as possible from the handpiece electrodes. Needle monitoring
electrodes are not recommended.
Failure of the equipment could result in an unintended increase of output
power.
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 BodyTite
in the same room with any of these substances or gases, prevent their
accumulation or pooling within the area where BodyTite procedures are
performed.
The operation of BodyTite 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.
Do not use BodyTite on patients with pacemakers or internal defibrillators.

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2.9 Device and Handpiece 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 BodyTite device console and the handpieces:
Figure 2-1:System Certification and Identification Label
Figure 2-2: 2 Footswitch label for all applications

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Section 2: Safety
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Figure 2-3: BodyTite Handpiece Labels
2.10 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.
▪System is classified as a IIb device defined by the Medical Device Directive
(93/42/EEC).

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Section 3: System Installation
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Section 3: System Installation
3.1 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 on-ly with one of the
same type and rating.
Proper grounding is essential for safe operation.
3.2 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 20-27oC
(68-79oF) and relative humidity of less than 80%.
3.3 Equipment List
The System includes the following:
▪System platform
▪Footswitch
▪Operator manual
▪Power cord
▪Handpieces

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Section 3: System Installation
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3.4 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 the device out of the box using top and bottom handles.

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Section 3: System Installation
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3.5 Installation
The System is designed for installation in a clinic environment. To install the System,
perform the following tasks:
▪Check the System and all its components for damage.
▪Connect the Footswitch.
▪Connect the power cord to the System inlet.
▪Plug the System power cord into an appropriate electrical outlet.
3.6 Moving the System:
▪Turn the System off.
▪Disconnect the Power Cord.
▪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 the handles when moving the System.
Upon unpacking check the System for mechanical damage (e.g., cracks in the
cable insulation).
Never lift, pull or push the System using the operating panel.
Always use the handles when moving the System.
Upon unpacking check the System for mechanical damage (e.g., cracks in the
cable insulation).

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3.7 System Disposal
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.

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Section 4: Device Description
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Section 4: Device Description
4.1 Rear Panel
Power cord inlet
100-240V~, 1A, 50-60Hz.
Fuse holder
Rating is T 2A, 250V. Replace fuses 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.
Table 4-1: Rear Panel Symbols
Figure 4-1: Handpiece Connector (Arrow) on Front Panel

!!

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Section 4: Device Description
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4.2 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 with touch panel.
On the front panel there is a black On/Off switch on the left, and handpiece connector
on the right.
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 the Handpiece is not connected to its connector on
the front panel.
4.3 Software Screens
The Splash Screen appears after the On-Off switch is turned on.
Figure 4-2: 2 Splash Screen
*The Software version number is displayed on the top of the screen and depends on the
product version.

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Section 4: Device Description
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After entering the individual code in the Login Screen, the system allows access to the
Treatment Screen.
Default Login code 1234 can be changed in the Utilities Screen. The Volume level can
also be reduced in the Utilities Screen.
Figure 4-3: Login Screen
Prior to entering the Treatment Screen, a self-test of the system module is performed.
After the end of the self-test, the Treatment Screen appears.
Figure 4-4: Treatment Screen