Invasix InMode User manual

wT
System
™
InMode
Operator Manual
Version: DO606736C

Operator Manual: InMode™ System with Diolaze™ / DiolazeXL™ 755/810, 810,
810/1064 / Lumecca™ / Fractora™ / Forma™ / Plus™ / BodyFX™ / MiniFX™
DO606736C
Copyright © Invasix Ltd.
Date: June 2018
All rights reserved. Contents of this publication may not be reproduced in any form
without the written permission of Invasix Ltd.
🏭Invasix Ltd
Tavor House, POB 533, Industrial Park South,
Yokneam, 2069206, Israel
For information call: [phone]
I InMode Spain
Pati de la Abadia nº1, Breda
17400 Girona, Spain
Contact person:
Jorge Alorda Guibernau
Tel.:[phone]
E-mail: [e-mail]

Table of Contents
Section 1: Introduction..............................................................................................
1.1Before You Start.....................................................................................................
1.2System Overview...................................................................................................
1.3Conventions Used in the Manual...........................................................................
1.4Explanation of the Symbols used on the System...................................................
Section 2: Safety........................................................................................................
2.1The Patient.............................................................................................................
2.2Treating Attendant................................................................................................
2.3Cautions.................................................................................................................
2.4Ocular Hazards.......................................................................................................
2.5Ocular Safety Considerations.................................................................................
2.6Electrical and Mechanical Safety...........................................................................
2.7Fire Hazards...........................................................................................................
2.8Safety Features of the System...............................................................................
2.9Safe Use of the Active Accessories........................................................................
2.10Warnings................................................................................................................
2.11Device Labels.......................................................................................................
2.12Handpiece Labels.................................................................................................
2.13Equipment Classification......................................................................................
Section 3: System Installation.................................................................................
3.1Electrical Requirements.......................................................................................
3.2Environmental Requirements..............................................................................
3.3Equipment List.....................................................................................................
3.4Unpacking............................................................................................................
3.5Installation...........................................................................................................
3.6Filling Water.........................................................................................................
3.7Moving the System..............................................................................................
3.8System Disposal...................................................................................................
Section 4: Device Description.................................................................................
4.1Rear Panel............................................................................................................
4.2Front Panel and Operator Control Panel.............................................................
4.3Software Screens.................................................................................................
4.4Sound Indicator....................................................................................................
4.5Cut-Off Temperature Control..............................................................................
4.6Handpieces...........................................................................................................
Section 5: System Operation..................................................................................
5.1Device Start-Up....................................................................................................
5.2System Shutdown................................................................................................

Section 6 –Diolaze Treatment Information...........................................................
6.1Indications for Use...............................................................................................
6.2Contraindications.................................................................................................
6.3Possible Adverse Effects......................................................................................
6.4Pre-treatment Recommendations.......................................................................
6.5Tip Cleaning Instructions Prior to Use.................................................................
6.6Treatment Recommendations.............................................................................
6.7Treatment Schedule.............................................................................................
6.8Post Treatment Recommendations.....................................................................
Section 7: DiolazeXL Treatment Information.........................................................
7.1Indications for Use...............................................................................................
7.2Contraindications.................................................................................................
7.3Possible Adverse Effects......................................................................................
7.4Pre-Treatment Recommendations......................................................................
7.5Tip Cleaning Instructions Prior to Use.................................................................
7.6Treatment Recommendations.............................................................................
7.7Treatment Schedule.............................................................................................
7.8Post-Treatment Recommendations.....................................................................
Section 8: Lumecca Treatment Information...........................................................
8.1Instructions for Use..............................................................................................
8.2Contraindications.................................................................................................
8.3Possible Adverse Effects......................................................................................
8.4Pre-Treatment.....................................................................................................
8.5Tip Cleaning Instructions Prior to Use.................................................................
8.6Treatment Recommendations.............................................................................
8.7Post-Treatment Recommendations.....................................................................
8.8Treatment Schedule.............................................................................................
Section 9: Fractora Treatment Information...........................................................
9.1Fractional Skin Resurfacing..................................................................................
9.2Instructions for Use..............................................................................................
9.3Contraindications.................................................................................................
9.4Possible Adverse Effects......................................................................................
9.5Pre-Treatment Recommendations......................................................................
9.6Tip Cleaning Instructions Prior to Use.................................................................
9.7Test Spots.............................................................................................................
9.8Treatment Recommendations.............................................................................
9.9Treatment Schedule.............................................................................................
9.10Treatment Recommendations-Post.....................................................................

Section 10: Forma/Plus Treatment Information....................................................
10.1Instructions for Use..............................................................................................
10.2Contraindications.................................................................................................
10.3Possible Adverse Effects......................................................................................
10.4Handpiece Cleaning Instructions Prior to Use.....................................................
10.5Pre-Treatment Recommendations......................................................................
10.6Treatment Recommendations.............................................................................
10.7Treatment Schedule.............................................................................................
10.8Post-Treatment Recommendations.....................................................................
Section 11: BodyFX/MiniFX Treatment Information.............................................
11.1Indications for Use...............................................................................................
11.2Contraindications.................................................................................................
11.3Possible Adverse Effects......................................................................................
11.4Handpiece Cleaning Instructions Prior to Use.....................................................
11.5Pre-Treatment Recommendations......................................................................
11.6Treatment Recommendations.............................................................................
11.7Treatment Schedule.............................................................................................
11.8Post-Treatment Recommendations.....................................................................
Section 12: System Maintenance...........................................................................
12.1Maintenance & Frequency..................................................................................
12.2Before and after each treatment.........................................................................
12.3Once a Week........................................................................................................
12.4Once a Month......................................................................................................
12.5Once a Year..........................................................................................................
12.6Filling Water for Diolaze, DiolazeXL and Lumecca...............................................
12.7Draining Water for Diolaze, DiolazeXL and Lumecca...........................................
12.8Draining the Laser/IPL Handpieces with the Water Draining Tool......................
12.9Replacing the Deionizer Cartridge.......................................................................
12.10Replacing the Capsule Filter.................................................................................
12.11Air Filter...............................................................................................................
Section13: Troubleshooting....................................................................................
13.1Description of Faults with All Handpieces...........................................................
Section 14: System Specifications..........................................................................
14.1Output Power Curves...........................................................................................
14.2EMC Safety...........................................................................................................
Table from IEC60601-1-2, / 5.2.2.1 C & F...............................................................

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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 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 InMode™ System is employing three different technologies for various aesthetic
applications –Laser, Intense Pulsed Light (IPL), and Radiofrequency (RF). The System
operates while in contact with any of the following Handpieces: Diolaze™,
DiolazeXL™ laser hand pieces for hair removal, Lumecca™ IPL for skin rejuvenation,
Fractora™ radiofrequency (RF) for fractional resurfacing, Forma™/Plus™ RF for facial
and body wrinkle treatment and BodyFX™/MiniFX™ RF for body contouring, fat and
cellulite treatment.
The System provides individual adjustment of treatment parameters to achieve
maximum efficiency and safety 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:
WARNING! This information is extremely important!
ATTENTION! Consult Accompanying Document.
Provides general information that is important to keep in mind.

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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 B Equipment.
Type BF Equipment
HF Isolated Patient Circuit
This equipment intentionally supplies non-ionizing RF
energy
Follow the operating instructions
Do not reuse/single use only. This symbol is used for
disposable one-time-use products.
CE Marking
Figure-1: Device Symbols

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Section 2: Safety
This chapter describes safety issues regarding the use and maintenance of the
, Lumecca™ IPL slaser HandpieceDiolazeXLDiolaze andInMode™ System with the
Handpieces, Fractora™, Forma™/Plus™ and BodyFX™/MiniFX™ RF Handpieces, with a
special emphasis on electrical, optical, and laser safety, as applicable.
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.
The laser, IPL or 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 report 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.
Jewelry and metal accessories that are within the activation range of the Handpiece
should be removed to avoid accidental laser/light reflection or RF conduction, as
applicable.
Protective eyewear must be used by patient during Diolaze and DiolazeXL lasers or
Lumecca IPL treatments.
Treating Attendant
Only authorized individuals with appropriate training and knowledge should operate,
assist in the operation of, or provide maintenance to the InMode System.

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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.
Protective goggles must be used by all treatment attendants when using the Diolaze
and DiolazeXL lasers or the Lumecca IPL.
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.
Ocular Hazards
The light emitted by the Diolaze and DiolazeXL Handpieces are capable of causing
serious eye damage or blindness. The light emitted by the Lumecca IPL Handpiece is
capable of causing eye irritation or damage.
All persons potentially subject to exposure must wear protective goggles or eyewear
whenever the main power is on, in accordance with national and international
standards. The protective eyewear must have an optical density (OD) of 5 or greater
at the Diolaze and DiolazeXL lasers wavelength of 730 - 1085nm (OD 5); 755nm (OD
7); 1064nm(OD >6); at the Lumecca IPL wavelength of 515-1200 nm. For users
outside the U.S., the protection values are for 730-1085, DIR LB5; for 755, DIR LB6 +
IR LB7; and for 1064, DIR LB6 + IR LB7. All approved by PSP S CE.
The laser and the IPL are to be operated only in an enclosed room with protective
eyewear for all persons; direct eye exposure is not safe at any distance within the
room. All windows in the laser room must be covered with opaque material, and
measures should be taken to prevent unauthorized access to the room. For the laser,
a remote Interlock is provided, which can be connected to the treatment room
doors, disabling laser output if the door is opened during a procedure. In addition,
compliance with ANSI Z1 36.3 and EN 60825-l requires that laser safety signs be
posted at all entrances whenever the laser is in use. Compliance with IEC 60601-2-57
requires that warning label from IR exposure be posted at all entrances whenever the
IPL is in use. Approved sign is provided with each system along with protective
eyewear. Additional eyewear or safety signs may be obtained from the
manufacturer.

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Never look directly into the laser aperture at the distal end of the Handpiece, even if
you are wearing safety glasses. Serious eye injury or blindness could result.
Avoid directing the laser beam anywhere other than the calibration port or intended
treatment area. Stray laser light and reflection is always a potential hazard and may
cause serious injury.
Do not treat eyebrows, eyelashes, eyelids or other areas within the bony area
surrounding the orbit. The light emitted by the laser or the IPL is capable of causing
serious eye damage or blindness. For maximum safety, metal eye goggles must be
worn by the patient for all facial treatments when laser is used.
Ocular Safety Considerations
Identify the laser room clearly by posting approved safety signs in prominent
locations.
Cover all windows to prevent laser light from escaping the laser room.
Restrict entry to the treatment room when the laser or IPL is in use. Allow access
to those personnel both essential to the procedure and well trained in safety
issues.
Never direct the laser beam at anything other than the calibration port or the
intended treatment site.
Never look directly into the laser aperture at the distal end of the Handpiece.
All persons in the treatment room must wear approved laser safety eyewear.
This includes the operator, patient, nurses, and any other persons in the
treatment room.
Do not attempt to remove the plastic shell protective covers on the Handpiece
which could allow exposure to high intensity laser light.
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.

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Move the System slowly and carefully. The System weighs approximately 32kg
(70lb.) and may cause injury if proper care is not used when moving it.
For RF Handpieces provide as much distance as possible between the system and
other electronic equipment as the activated RF generator may cause interference
between them.
Fire Hazards
The absorption of diode laser or IPL energy raises the temperature of the
absorbing material. Do not use the System in the presence of explosive or
flammable materials.
Materials conducting RF energy causes 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, 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.
The System has a unique password to avoid device operation by non-authorized
personnel.
The power electronics cannot be fully activated unless the Applicator and
Footswitch have been connected to the System. With IPL, connection of the
Applicator is sufficient.
An audible tone indicates energy activation.
During activation, the System performs a self-test of the hardware.
The hardware is tested every 10ms to ensure proper operation of electrical
circuit.
The System starts at a low power setting.

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Temperature monitoring disables the System operation if the Handpiece
sapphire temperature is outside the operating range for Diolaze and DiolazeXL
and Lumecca Handpieces.
The power electronics cannot be fully activated unless the laser or RF Handpieces
and Footswitch have been connected to the System. With IPL Handpieces, the
connection of the Applicator is sufficient.
Diolaze and DiolazeXL Handpieces contains a comprehensive monitoring system
that allows operation only when numerous safety conditions have been met. A
fault must be corrected and the system reset before laser operation is re-
enabled. Monitoring includes the following:
Remote Interlock allows laser emission only when there is electrical continuity
across the contacts of the remote Interlock Connector (located on the rear of the
Console). The System is shipped with a remote Interlock Jumper already
connected, providing electrical continuity and allowing the laser to operate. To
set up a remote Interlock Switch, such as on the treatment room door, please
contact qualified personnel.
The Diolaze and DiolazeXL Hand Triggers allow laser emission only when the
Footswitch is pressed.
Laser Energy monitoring to verify that the laser output is within specific energy
tolerances for every laser pulse. If abnormally low or high, the laser current
(indicative of optical energy) is detected, a System fault is triggered, and the user
is notified.
As a safety feature and in compliance with U.S. and international regulations, the
Diolaze and DiolazeXL Handpieces contain an Electronic Shutter to help prevent
inadvertent laser emissions. The Shutter which is located on the Console, is an
electronic switch that is independent of, and in addition to, the normal energy
circuit for the laser when it is ON.
Releasing the Diolaze and DiolazeXL Handpiece Trigger will stop laser emissions.
In the event of an emergency, the laser can be shut down immediately by
pushing the Emergency Stop Button located on the Console. To restore
operations, rotate the Button clockwise until it pops out again. Then follow the
standard startup sequence. Since the Emergency Stop Button is not intended for
routine use, please follow the procedure in the System Operation Section for
normal shutdown.
For the RF applications:
There is skin temperature monitoring for Forma, Plus, and BodyFX/MiniFX.
There is vacuum level monitoring for BodyFX/MiniFX. RF is disabled when the
vacuum is below the predetermined level.

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Safe Use of the Active Accessories
Examine the connection of the Handpiece through the Connector 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.
Don’t direct the laser or IPL towards the window, other treatment attendants or
on patient areas that are not intended to be treated.
When using the RF applicators, ensure that all electrodes are in full contact with
the skin. Bad coupling of both electrodes (FORMA/PLUS, BodyFX/MiniFX) with
the skin results in a specific warning sound, a message on the screen, and
disabling of RF.
Warnings
Do not connect a wet accessory to the System.
Do not immerse the Applicator under water at any time.
This equipment is for use only by trained, licensed physicians.
Only Handpieces manufactured or approved by Invasix 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 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 and treatment attendants must use protective eyewear during
the use of laser and IPL.

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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!
Use the lowest output setting necessary to achieve the desired treatment
effect. The higher optical or RF energy is applied, the greater the possibility
of unintended thermal damage of skin.
Failure of the equipment could result in an unintended increase of output
power.
The cables of the Handpieces 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 optical or RF energy and heating associated with the System 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 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 mains supply with protective earth.

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Device Labels
As required by national and international regulatory agencies, appropriate warning
and information labels have been attached to specific locations on the instrument as
identified below. The following device labels are located on the InMode device
console:
Figure-1: System Certification and Identification Label
Figure-2: Laser Emission Warning Label

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Figure-3: Laser Interlock Label
Figure-4: IPL Warning Label
Figure-5: IPL Emission Warning Label

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Figure-6: Emergency Stop Label on the emergency Red Button
Figure-7: Footswitch Label for All Application
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.

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The following labels are located on the Handpieces:
Figure-8: All Handpieces Identification Labels

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Figure-9: DiolazeXL Handpieces Connector Labels
Figure-10: Diolaze and DiolazeXL Handpiece Label for Laser Aperture
Figure-11: 10 Lumecca Handpiece Label for IPL Aperture
Equipment Classification
The following is a list of the different equipment used and their classifications.
Electric shock protection: Class I, Defibrillation-proof Type B for the optical
Handpieces –Diolaze, DiolazeXL and Lumecca, and Type BF for the RF Handpieces
Fractora, Forma/Plus, and BodyFX/MiniFX.
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.

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The InMode System with the Diolaze and DiolazeXL Handpieces complies with 21
CFR, Chapter L Subchapter J, as administered by the Center for Devices and
Radiological Health (CDRH) of the Food and Drug Administration (FDA). CE-labeled
devices comply with all appropriate performance standards as specified in Annex II of
the Medical Device Directive MDD 93/42/EEC. The InMode System with Diolaze and
DiolazeXL Handpieces is classified as a Class IV laser by the CDRH and as a Class 4
laser by the European Standard EN 60825-l.
Caution - Use of controls or adjustments or performance of procedures other than
those specified herein may result in hazardous laser radiation exposure.
The InMode System with IPL Handpiece is classified as IIb device defined by the
Medical Device Directive (93/42/EEC) for CE marking.
The InMode System with Fractora, Forma, Plus, and BodyFX/MiniFX Handpieces is
classified as IIb device defined by the Medical Device Directive (93/42/EEC) for CE
marking.