InMode Optimas User manual

Optimas System
Operator Manual
Version: DO607449A

Operator Manual: Optimas System with DiolazeXL, Vasculaze, Lumecca, Fractora and
Forma Handpieces
DO607449A
Copyright © InMode MD Ltd.
Date: August 2018
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
Yokneam, 206926, POB 44, Israel
Tel.: [phone]
Fax: [phone]

Table of 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................................................... 2
Section 2: Safety ................................................................................................ 3
2.1 The Patient............................................................................................................. 3
2.2 Treating Attendant................................................................................................. 3
2.3 Cautions ................................................................................................................. 4
2.4 Ocular Hazards ....................................................................................................... 4
2.5 Ocular Safety Considerations................................................................................. 5
2.6 Electrical and Mechanical Safety ........................................................................... 6
2.7 Fire Hazards............................................................................................................ 6
2.8 Safety Features of the System ............................................................................... 7
2.9 Safe use of the Active Accessories......................................................................... 8
2.10 Warnings ................................................................................................................ 9
2.11 Device Labels........................................................................................................ 10
2.12 Handpieces Labels................................................................................................ 13
2.13 Equipment Classification...................................................................................... 15
Section 3: System Installation .......................................................................... 16
3.1 Electrical Requirements ....................................................................................... 16
3.2 Environmental Requirements .............................................................................. 16
3.3 Equipment List ..................................................................................................... 16
3.4 Unpacking............................................................................................................. 17
3.5 Installation ........................................................................................................... 18
3.6 Filling Water ......................................................................................................... 18
3.7 Moving the System .............................................................................................. 18
3.8 System Disposal ................................................................................................... 19
Section 4: Device Description ........................................................................... 20
4.1 Rear Panel ............................................................................................................ 20
4.2 Front Panel and Operator Control Panel ............................................................. 21
4.3 Software Screens.................................................................................................. 22
4.4 Sound Indicator.................................................................................................... 29
4.5 Cut-Off Temperature Control............................................................................... 29
4.6 Handpieces........................................................................................................... 30
Section 5: System Operation ............................................................................ 34
5.1 Device Start-Up .................................................................................................... 34
5.2 System Shutdown ................................................................................................ 35

Section 6: DiolazeXL Treatment Information .................................................... 36
6.1 Instructions for Use.............................................................................................. 36
6.2 Contraindications................................................................................................. 36
6.3 Possible Adverse Effects....................................................................................... 37
6.4 Pre-treatment Recommendations ....................................................................... 38
6.5 Tip Cleaning Instructions Prior to Use.................................................................. 38
6.6 Treatment Recommendations ............................................................................. 38
6.7 Treatment Schedule............................................................................................. 40
6.8 Post-treatment Recommendations ..................................................................... 40
Section 7: Vasculaze Treatment Information .................................................... 41
7.1 Indications for Use ............................................................................................... 41
7.2 Contraindications................................................................................................. 41
7.3 Possible Adverse Effects....................................................................................... 42
7.4 Pre-treatment Recommendations ....................................................................... 42
7.5 Tip Cleaning Instructions Prior to Use.................................................................. 43
7.6 Treatment Recommendations ............................................................................. 43
7.7 Treatment Schedule............................................................................................. 45
7.8 Post-treatment Recommendations ..................................................................... 45
Section 8: Lumecca Treatment Information ...................................................... 46
8.1 Indications for Use ............................................................................................... 46
8.2 Contraindications................................................................................................. 46
8.3 Possible Side Effects............................................................................................. 47
8.4 Pre-treatment Recommendations ....................................................................... 47
8.5 Tip Cleaning Instructions Prior to Use.................................................................. 48
8.6 Test Spots............................................................................................................. 48
8.7 Treatment Recommendations ............................................................................. 49
8.8 Post-treatment Recommendations ..................................................................... 51
8.9 Treatment Schedule............................................................................................. 51
Section 9: Fractora Treatment Information....................................................... 52
9.1 Fractional Skin Resurfacing .................................................................................. 52
9.2 Indications for Use ............................................................................................... 52
9.3 Contraindications................................................................................................. 52
9.4 Possible Adverse Side Effects............................................................................... 54
9.5 Pre-treatment Recommendations ....................................................................... 54
9.6 Tip Cleaning Instructions Prior to Use.................................................................. 55
9.7 Test Spots............................................................................................................. 55
9.8 Treatment Recommendations ............................................................................. 56
9.9 Treatment Schedule............................................................................................. 58
9.10 Post-treatment Recommendations ..................................................................... 58
Section 10: Forma Treatment Information........................................................ 60
10.1 Indications for Use ............................................................................................... 60

10.2 Contraindications................................................................................................. 60
10.3 Possible Adverse Effects....................................................................................... 61
10.4 Handpiece Cleaning Instructions Prior to Use ..................................................... 61
10.5 Pre-treatment Recommendations ....................................................................... 62
10.6 Treatment Recommendations ............................................................................. 62
10.7 Treatment Schedule............................................................................................. 65
10.8 Post-treatment Recommendations ..................................................................... 65
Section 11: System Maintenance...................................................................... 67
11.1 Maintenance & Frequency................................................................................... 67
11.2 Before and after each treatment......................................................................... 67
11.3 Once a Week ........................................................................................................ 67
11.4 Once a Month ...................................................................................................... 67
11.5 Once a Year .......................................................................................................... 67
11.6 Filling Water for DiolazeXL, Vasculaze and Lumecca ........................................... 68
11.7 Draining Water for VASCULAZE, DIOLAZEXL and LUMECCA................................ 70
11.8 Draining the Laser/IPL Handpieces with the Water Draining Tool ...................... 71
11.9 Replacing the Deionizer Cartridge ....................................................................... 72
11.10 Replacing the Capsule Filter................................................................................. 73
11.11 Air Filter................................................................................................................ 74
Section 12: Troubleshooting............................................................................. 76
12.1 Description of Faults with All Handpieces ........................................................... 76
Section 13: System Specifications..................................................................... 78
13.1 Output Power Curves........................................................................................... 80
13.2 EMC Safety ........................................................................................................... 81
Table from IEC60601-1-2, / 5.2.2.1 C&F ............................................................ 86

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Section 1: Introduction
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Section 1: Introduction
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 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.
1.2 System Overview
The InMode Platform with DiolazeXL, Vasculaze, Lumecca, Fractora and Forma
Handpieces is marketed as the Optimas System which employs three different
technologies for various aesthetic applications –Laser, Intense Pulsed Light (IPL), and
Radio-frequency (RF).
The Optimas System operates while in contact with any of the following Handpieces:
DiolazeXL (laser for hair removal), Vasculaze (laser for vascular lesions), Lumecca (IPL
for skin rejuvenation), Fractora (RF for fractional resurfacing), and Forma (RF for
facial wrinkle treatment). The System provides individual adjustment of treatment
parameters to achieve maximum efficiency and safety for each patient.
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.
NOTE! Provides general information that is important to keep in mind.

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1.4 Explanation of the Symbols used on the System
Symbol
Description
CSA marking
(212603 CSA master contract number)
Do not discard in trash. Electronic equipment should
be disposed of in an appropriate manner
Fuse
Type BF Equipment
Type B Equipment.
HF Isolated Patient Circuit
Follow the operating instructions
Federal (US) law restricts this device to sale by the
order of a physician licensed by the law of the state
in which he practiced to use or order the use of the
device
Do not reuse/single use only. This symbol is used for
disposable one-time-use products.
This equipment intentionally supplies non-ionizing RF
energy
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
Optimas System, with a special emphasis on electrical and laser 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 the treating
attendant and the 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.
2.1 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 the patient during DiolazeXL laser, Vasculaze
laser or Lumecca IPL treatments
2.2 Treating Attendant
▪Only authorized individuals with appropriate training and knowledge should
operate, assist in the operation of, or provide maintenance to the Optimas
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
DiolazeXL laser, Vasculaze laser or the Lumecca IPL Handpieces
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 personal only.
▪To avoid damage, do not allow the Handpiece to come in contact with hard
materials.
2.4 Ocular Hazards
▪The light emitted by the DiolazeXL laser Handpieces and Vasculaze laser
Handpiece is capable of causing serious eye damage or blindness. The light
emitted by the Lumecca handpieces 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 DiolazeXL wavelength of 810nm, and at the Lumecca
wavelength of 515-1200nm.
▪For users outside the U.S., the appropriate standard may be EN 207, in which
case the safety eyewear must have a protection class of L5. The protective
eyewear must have an optical density (OD) of 5 or greater at the DiolazeXL laser
wavelength of 730 - 1085nm (OD 5); 755nm (OD 7); 1064nm (OD >6); at the
Vasculaze laser wavelength 1064nm (OD >6)) and at the Lumecca IPL wavelength
of 515-1200 nm. For users outside the U.S., the protection values are for
1064nm, DIR LB6 + IR LB7, 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.

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▪For the laser, 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 IEC60601-2-57 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.
▪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, 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.
2.5 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.

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2.6 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.
▪Move the System slowly and carefully. The System weighs approximately 32kg
(70.5lb.) 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.
2.7 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 may cause temperature rise of the absorbing
material. Do not use the System in the presence of explosive or flammable
materials conductive to RF.
▪Do not use flammable substances when preparing the skin for treatment. Be
especially careful with the use of oxygen.
▪Keep drapes and towels moist to prevent them from igniting and burning. Use
nonflammable prepping solutions.
▪If alcohol is used for cleaning and disinfecting, it must be allowed to dry
thoroughly before the System is used.

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2.8 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 unique password to avoid device operation by non-authorized
personnel.
▪The power electronics cannot be 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.
▪Hardware is tested every 10ms to ensure proper operation of electrical circuit.
▪Tissue impedance monitoring prevents accidental RF energy emission to the
patient.
▪Skin surface is monitored during the treatment of Forma Handpiece. RF energy
delivery is terminated when skin temperature reaches the Cut-Off level.
▪The System starts at a low setting.
▪Temperature monitoring which disables system operation if the Handpiece
sapphire temperature is outside the operating range for, DiolazeXL, Vasculaze
and Lumecca Handpieces only.
The System with the DiolazeXL and Vasculaze Handpieces includes 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. The monitoring system includes the following:
▪Remote interlock that allows laser emission only when electrical continuity is
made 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 DiolazeXL and Vasculaze 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 laser current
(indicative of optical energy) is detected, a System fault is triggered and the user
is notified.

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▪Temperature monitoring which disables System operation if the Handpiece
sapphire temperature is outside the operating range.
▪As a safety feature and in compliance with U.S. and international regulations, the
DiolazeXL and Vasculaze Handpieces contain an electronic shutter to help
prevent inadvertent laser emission. Located in the console, the shutter is an
electronic switch that is independent of, and in addition to, the normal energy
circuit for the laser ON.
▪Releasing the DiolazeXL and Vasculaze Handpiece’s trigger will stop laser
emission. 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
operation, rotate the button in the clockwise direction until it pops out again.
Then follow the standard startup sequence. Since the emergency stop switch is
not intended for routine use, please follow the procedure in the System
Operation Section for normal shutdown.
For the RF applications:
There is a skin temperature monitoring for Forma Handpiece.
2.9 Safe use of the Active Accessories
▪Examine the connection of the Handpiece through the connectors to the System
before using. Ensure that the accessory functions as intended. Improper
connection may result in arcs and sparks, accessory malfunction, or unintended
treatment effects.
▪Do not wrap the Handpiece cords around metal objects. It may induce current
that could lead to electrical shocks, fire or injury to the patient or personnel.
▪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 both electrodes are in full contact
with the skin. Bad coupling of electrodes with the skin results in a specific
warning sound, a message on the screen, and disabling of RF.
Do not connect a wet accessory to the System.
Do not immerse the applicator under water at any time.

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2.10 Warnings
This equipment is for use only by qualified medical professionals trained in
the particular technique to be performed.
Only handpieces manufactured or approved by InMode MD Ltd. should be
used with Optimas 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.
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 RF or laser/IPL energy is applied, the greater the
possibility of unintended thermal damage.
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.

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–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 Optimas in the same room with any of these substances or gases,
prevent their accumulation or pooling within the area where Optimas
procedures are performed.
The operation of the Optimas 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.
2.11 Device Labels
As required by national and international regulatory agencies, appropriate warning
and information labels have been attached in specific locations on the instrument as
identified below.
The following device labels are located on the Optimas device console and the
handpiece:
Figure 2-1: System Certification and Identification Label

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Figure 2-2: Laser Emission Warning Label
Figure 2-3: Emergency STOP Label on Emergency Red Button
Figure 2-4: 4 IPL Warning Label

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Figure 2-5: IPL Emissions Warning Label
Figure 2-6: Interlock and Footswitch Label
Figure 2-7: USA Federal Restriction Label

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2.12 Handpieces Labels
The Handpiece certifications 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. The following labels are located on the Handpieces:
Manufacturer identification labeling is placed on the Hand pieces:
▪Laser aperture label placed on the Handpiece connector.
▪Manufacturer identification labeling placed on the Handpiece connector.
Figure 2-8: Lumecca Handpieces Label for IPL Aperture
Figure 2-9: DiolazeXL and Vasculaze Handpieces Label for Laser Aperture

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Figure 2-10: All Handpiece Identification Labels
Figure 2-11: DiolazeXL 810 Handpiece Connector Label

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2.13 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 - DiolazeXL, Vasculaze and Lumecca, and Type BF for the RF
Handpieces –Fractora and Forma.
▪Protection against ingress of liquids: Ordinary equipment.
▪Not suitable for use in presence of flammable substance.
▪Power receptacle must include protective earth and must be checked before
connecting the System.
The Optimas System with d DiolazeXL and Vasculaze 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 III
of the Medical Device Directive MDD 93/42/EEC. The Optimas System with DiolazeXL
and Vasculaze Handpieces is classified as a Class IV laser by the CDRH and as a Class 4
laser by the European Standard EN 60825-l.
The Optimas System with Lumecca IPL Handpieces is classified as IIb device
defined by the Medical Device Directive (93/42/EEC) for CE marking. The
Optimas System with RF Handpieces - Fractora and Forma is classified as IIb
device defined by the Medical Device Directive (93/42/EEC) for CE marking.
Use of controls or adjustments or performance of procedures other than
those specified herein may result in hazardous laser radiation exposure.