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...............................................................

InMode Without Vasculaze Operator Manual
Section 1: Introduction

1 of 96
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.

InMode Without Vasculaze Operator Manual
Section 1: Introduction

2 of 96
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

InMode Without Vasculaze Operator Manual
Section 2: Safety

3 of 96
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.

InMode Without Vasculaze Operator Manual
Section 2: Safety

4 of 96
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.

InMode Without Vasculaze Operator Manual
Section 2: Safety

5 of 96
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.