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.: +972-4-9096313
Fax: +972-4-9096310
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.
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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. Zmax = 0.03Ω.
▪ Power receptacles must be within 15 feet of the System site.
▪ The System should not share a power line with other equipment.
▪ Power receptacle must include protective earth and must be checked before
connecting the System.
For continued protection against fire, replace the fuse only with one of the
same type and rating.
Proper grounding is essential for safe operation.
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
20º-27ºC (68º-79ºF) and relative humidity of less than 80%.
3.3 Equipment List
The System includes the following:
▪ System platform
▪ Handpieces
▪ Handpieces cradles
▪ Footswitch
▪ Operator manual
▪ Power cord
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▪ User protective goggles
▪ Patient eyewear
▪ “Laser Danger” door sign
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.
▪ Add water. Use the Maintenance Screen.
▪ Connect cradle to the device (Fig. 3.1).
▪ Connect Handpiece to the connector and place into the cradle.
▪ Connect the Footswitch.
▪ Connect the power cord to the System inlet.
▪ Plug the System Power Cord into an appropriate electrical outlet.
Figure 3-1: Cradle Connections to the Device
3.6 Filling Water
Optimas System and DiolazeXL, Vasculaze and Lumecca Handpieces are shipped
without water. Distilled water must be used and failure to do so will void the service
warranty. For detailed instructions refer to Section 10 – System Maintenance.
3.7 Moving the System
▪ Turn the System off.
▪ Disconnect the Power Cord.
▪ Disconnect the Handpieces.
▪ Disconnect the Footswitch.
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▪ Release the Wheel Brakes.
▪ Slowly push or pull the System using the handle.
▪ When moving the System to another facility, lift the System to the vehicle and lay
it carefully on its side.
▪ For shipment with DiolazeXL, Vasculaze and Lumecca, drain the water from the
System and the Handpieces, as described in Section 9 - System Maintenance.
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 leave the System or/and handpieces with water in, exposed to
freezing temperatures (< 4°C).
3.8 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~, 15A, 50-60Hz.
Fuse Holder
Rating is T 12A, 250V. Replace fuses if needed, only with fuses having
exactly the same rating.
Software Flash Memory Plug
The software plug is a flash memory with the machine software. The
software plug should be screwed to the connectors. To tighten and/or
loosen the screws use fingertips only. Do not use screwdriver as it can
damage the connectors.
Footswitch Connector
Footswitch is connected to the inlet. Footswitch activates RF energy if
the System is in Ready mode. Place the Footswitch on the floor near
the treatment area.
RF Handpiece
Connector
The Handpiece connector is located on the upper right side of the rear
panel and connects to one of the RF Handpieces (Fractora and Forma).
Figure 4-1: RF Connector on the Rear Panel (Arrow)
!!
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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 touch screen.
On the front panel, there is a grey On/Off switch on your left, a red Emergency Stop
Button on the right, and a Handpiece connector (arrow) in the center for either
DiolazeXL, Vasculaze or Lumecca.
Figure 4-2: Front Panel and Operator Control Panel with Optical Handpiece connector
(Arrow)
Power On-Off
Switch
Power switch turns System On and Off.
Optical
Handpiece
Connector
Located in the center of the front panel and connects to one of
the optical Handpieces.
Emergency Stop
Button
Stops the power instantly in emergency conditions.
LCD Screen
▪ The LCD screen shows information about the System mode
and treatment parameters.
▪ The panel allows changing treatment parameters and
System mode.
Power electronics is not activated if no Handpiece is connected to its connector on
the front or the rear panel. The System recognizes the connected Handpiece and
enables opening the relevant screen, except for Fractora and Forma that the user has
to ascertain the match between the Handpiece connected on the rear panel and the
screen.
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4.3 Software Screens
The Progress screen appears after the On-Off switch is turned on.
Figure 4-3: Progress Screen
*The SW version number will be displayed according to the software version.
After entering the individual code on the Login Screen, non-authorized use of the
device is prevented.
Figure 4-4: Login Screen
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Section 4: Device Description
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Software is loaded from the plug and self-test of the System modules is performed.
After the end of the self-test the Menu Screen appears.
Figure 4-5: Menu Screen
The Menu Screen allows the selection of the connected Handpiece, or entry to the
Utilities Screen.
Figure 4-6: Utilities Screen
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The Utility Screen contains:
Volume
This function allows the user to adjust the System volume.
Drain / Fill
Water
Drain water from the DiolazeXL, Vasculaze and Lumecca
Handpieces and System prior to shipment and fill water during
installation.
Change
Password
Change the password by entering the old password and then
entering another 4-digit password.
Calibration
External validation module for optical Handpieces – DiolazeXL,
Vasculaze and Lumecca.
Main Menu
Return to the Main Menu to select an applicator.
After returning to the Menu Screen and choosing the application on the Menu
Screen, the corresponding Treatment Screen appears.
When choosing the DIODE icon on the Menu Screen, the System recognizes the
connected DiolazeXL Handpiece.
Figure 4-7: DiolazeXL Treatment Screen
The DiolazeXL Treatment Screen contains:
Selection Frame
The frame selects parameters that can be changed by the
function keys.
Fluence
Fluence (light energy density) is changed within the limits from
5 to 40J/cm² for DiolazeXL and the System starts up at the
minimal setting.
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Cooling
Normal and Strong cooling, 12 and 7oC, respectively, can be
selected for DiolazeXL.
Pulse Width
Short or Long pulse can be selected for DiolazeXL.
Pulse Mode
Note:
pps = Pulse Per
Second
Off (Single) 5-40J/cm2
1pps 5-40J/cm2
2pps 5-25J/cm2
Glide 5-10J/cm2
Counter Reset
The Pulse Counter can be reset.
Pulse Counter
Shows the number of pulses delivered from the beginning of
the treatment.
System Mode
The System has four treatment modes:
Standby mode - allows the user to set treatment parameters.
Activation of energy is not allowed in Standby mode.
Armed mode - when the Footswitch is pressed, before the hand
trigger.
Ready mode - when the System is waiting for a signal from the
trigger switch to activate the energy. Any attempt to change
the treatment settings switches the System to Standby mode.
Active mode - when the laser is pulsed by pressing the hand
trigger.
Main Menu
Return to the Main Menu to select another applicator and
change the applicator if needed.
When choosing the DIODE icon on the Menu Screen, the System recognizes the
connected Vasculaze Handpiece.
Figure 4-8: Vasculaze Treatment Screen
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The Vasculaze Treatment Screen contains:
Selection Frame
The frame selects parameters that can be changed by the
function keys.
Fluence
Fluence (laser energy density) is changed within the limits from
100 to 300J/cm², and the System starts up at the minimal
setting.
Cooling
Select between Strong and Normal cooling of lightguide.
Pulse Mode
Select between Off (Single pulse) or 1pps (Pulse Per Second).
Pulse Width
Short or Long pulse can be selected.
Counter Reset
The Pulse Counter can be reset.
Pulse Counter
Shows the number of pulses delivered from the beginning of
the treatment.
System Mode
The System has four treatment modes:
Standby mode- allows the user to set treatment parameters.
Activation of energy is not allowed in Standby mode.
Armed mode - when the Footswitch is pressed, before the hand
trigger.
Ready mode - when the System is waiting for a signal from the
trigger switch to activate the energy. Any attempt to change
the treatment settings switches the System to Standby mode.
Active mode - when the laser is pulsed by pressing the hand
trigger.
Main Menu
Return to the Main Menu to select another applicator and
change the applicator if needed.
Figure 4-9: Lumecca 580 Treatment Screen (same screen for 515)
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The Lumecca 580 or 515nmTreatment Screen contains:
Selection
Frame
The frame selects parameters that can be changed by the function
keys.
Fluence
Fluence (light energy density) is changed within the limits from 5 to
30J/cm² for Lumecca and the System starts up at the minimal
setting.
Cooling
Normal and Strong cooling can be selected for Lumecca.
Pulse Width
Short or Long pulse can be selected.
Pulse Mode
Repeat mode in Normal or Fast repetition rate or in Off as a single
pulse mode.
Counter Reset
The Pulse Counter can be reset.
Pulse Counter
Shows the number of pulses delivered from the beginning of the
treatment.
System Mode
The System has three treatment modes, Standby, Ready, and
Active.
Standby mode - allows the user to set treatment parameters.
Activation of energy is not allowed in Standby mode.
Ready mode - the System is waiting for a signal from the
Footswitch to activate the energy. Any attempt to change the
treatment settings switches the System to Standby mode.
Active mode - when the signal from the Footswitch is indicated,
the System switches to Active mode. Any attempt to change the
treatment settings switches the System to Standby mode
Main Menu
Return to the Main Menu to select another applicator and change
the applicator if needed.
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Figure 4-10: Fractora Treatment Screen
The Fractora Treatment Screen contains:
Selection
Frame
The frame selects parameters that can be changed by the function
keys.
Tip Type
Allows selecting between different tip types of Fractora.
Energy
Delivered energy is changed from level 5 to 62 energy levels and
the System starts up at the minimal energy setting.
Pulse Mode
Allows choosing between single pulse and pulse trains ranging from
0.5 to 2 pulses per second (pps).
Counter Reset
The Counter can be reset.
Pulse Counter
Shows number of pulses delivered on one zone and the total
number of pulses from the beginning of the treatment.
System Mode
The System has three treatment modes: Standby, Ready, and
Active.
Standby mode- allows the user to set treatment parameters.
Activation of energy is not allowed in Standby mode.
Ready mode - the System is waiting for a signal from the foot
switch to activate the energy. Any attempt to change the
treatment settings switches the System to Standby mode.
Active Mode - when the signal from the Footswitch is indicated,
the System switches to Active mode. Any attempt to change the
treatment settings switches the System to Standby mode.
Main Menu
Return to the Main Menu to select another applicator and change
the applicator if needed.
Figure 4-11: Forma Treatment Screen
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Section 4: Device Description
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The Forma Treatment Screen contains:
Selection Frame
The frame selects parameters that can be changed by the
function keys.
Energy
Delivered energy is changed from level 20 to 62 energy levels
and the System starts up at the minimal power setting.
Cut Off
Cut-off temperature settings are changed in the range of 3543oC. When measured skin surface temperature reaches the
pre-set limit the RF energy is cut off.
Pulse Mode
Allows selecting between single RF pulses of 30sec in the Single
Mode, and continuous RF in Repeat Mode, when the Footswitch
is pressed.
Counter Reset
The Counter can be reset.
Temperature
Measure
This indicator shows the skin surface temperature, as measured
by an integral temperature sensor.
Treatment Time
This function shows the total time that RF is activated.
System Mode
The System has three treatment modes, Standby, Ready, and
Active.
Standby mode- allows the user to set treatment parameters.
Activation of energy is not allowed in Standby mode.
Ready mode- the System is waiting for a signal from the
Footswitch to activate the energy. Any attempt to change the
treatment settings switches the System to Standby mode.
Active mode - when the signal from the Footswitch is indicated,
the System switches to Active mode. Any attempt to change the
treatment settings switches the System to Standby mode.
Main Menu
Return to the Main Menu to select another applicator and
change the applicator if needed.
4.4 Sound Indicator
▪ A periodic beeping signal is emitted when RF energy is delivered.
▪ A warning sound tone indicates Bad Coupling.
4.5 Cut-Off Temperature Control
The cut-off temperature up to an upper limit of temperature of 43°C is constantly
maintained for the Forma Handpiece. When the measured temperature approaches
the Cut-off Temperature, the tone beeps double in speed. It becomes faster when
the Cut-off Temperature is reached and RF is instantly inactivated. As soon as the
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temperature drops below the Cut-off temperature, RF starts again, thus maintaining
the desired temperature with safety and when reached, RF delivery is automatically
stopped. Temperature is monitored by a temperature sensor in the Handpiece and
serves as a safety feature.
4.6 Handpieces
The DiolazeXL Handpiece comprises applicator, cable and connector.
Figure 4-12: DiolazeXL Handpiece
Applicator
Comprises DiolazeXL diode laser of 810nm diode bar. There is a
cooled sapphire output window (11X27.5mm), and electronic
shutter (Figure 4-12).
Cable
Has a length of 170cm.
Connector
The Connector is connected to the System.
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The Vasculaze Handpiece comprises applicator, cable and connector.
Figure 4-13: Vasculaze Handpiece
Applicator
The Vasculaze laser comprises a cooled sapphire output window
(3x4mm) and electronic shutter (Figure 4-13).
Cable
The Cable has a length of 170cm.
Connector
The Connector is connected to the System.
Each of the Lumecca Handpieces (515 and 580) comprises an applicator, cable and
connector
Figure 4-14: Lumecca Handpiece
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Applicator
Comprises flash lamp and reflector emitting optical energy through
the pre-cooled light guide (30x10mm) (Figure 4-14).
Cable
The Cable has a length of 170cm.
Connector
The Connector is connected to the System.
The Fractora Handpiece comprises applicator, cable and connector (Figure 4-15). Single use tip
is connected to the groove in the handle before each use (Figure 4-16). The tip is connected or
disconnected by pull or push movement.
Figure 4-15: Fractora Handpiece
Handle
The Handpiece handle is made of metal and has ergonomic design
for easy treatment with high visibility of the treated area (Figure
4-15) .
Cable
The Cable has a length of 280cm (110’’).
Connector
The Connector is connected to the rear panel of the System.
Tips
The Handpiece tips have 2 sizes of pin arrays (Figure 4.14). 60 pins
are 600µ long, and 24 pins are 2500µ long.
Figure 4-16: Fractora Tips: Left 60 pin; Right 24 pin (coated/noncoated)
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The Forma Handpiece comprises applicator, cable, connector and an integral
temperature sensor (Figure 4-17).
Figure 4-17: Forma Handpiece
Tip
The Tip is a part of the Handpiece, comprising RF electrodes and a
temperature sensor.
Handle
The Handpiece handle is made of metal and has an ergonomic
design for easy treatment, with high visibility of the treated area.
Cable
The Cable has a length of 280cm (110’’).
Connector
The Connector is connected to the rear panel of the System.
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Section 5: System Operation
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Section 5: System Operation
This section of the manual explains how to start the device, operate it, and turn it off.
Prior to using or connecting the Handpiece, inspect the System and
Handpiece for possible mechanical damage.
5.1 Device Start-Up
1. Connect the handpiece to the handpiece connector socket on the System.
2. Turn on Main Power switch at the rear panel.
3. Press the On-Off button on the control panel to turn the device on. The System
loads the software and enters the Login Screen.
4. Enter unique password to get access to the device. If password is correct the
System enters Menu Screen.
5. The System loads the software and enters a self-test mode. If any problem is
detected during the test the error message will appear (See Troubleshooting
Section in this manual). If the test is passed correctly then the System
automatically enters the Menu Screen.
6. Select the application from the Menu Screen and System will enter the
Treatment Screen.
7. Verify on the screen that the Software version is properly displayed and the
connected Handpiece type is recognized correctly.
8. Apply the Handpiece to the treated area, ensuring a full contact.
9. Select the treatment parameters using Up and Down keys.
10. Press the Standby icon that will change to Ready.
11. To start treatment, press the Footswitch for RF applicators, press the Hand-
Trigger button for IPL applicators, and press the Footswitch followed by the
Hand-Trigger press for laser applicators.
The following information relates to the lasers only –DiolazeXL and Vasculaze.
4. When Cooling Down is completed, within 1 minute, the icon will change to
Ready.
5. If the laser is not activated within 3min, the System will go back to Standby
mode.
6. Apply handpiece to the treated area, ensuring a full contact with pressure.
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Section 5: System Operation
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7. Press Standby icon that will change to Ready.
8. Press the Footswitch and then press trigger button on the Handpiece to start
the treatment for DiolazeXL and Vasculaze; After pressing the foot-switch the
icon will change to Armed.
9. After pressing the Hand Trigger the icon will change to Active Trigger and the
laser can be emitted to start the treatment.
10. Lasing is apparent by blue light running around the window in the handpiece
and by an audio signal.
11. During treatment, when the laser window is heating up, the System will go into
Cooling Down mode. Wait until the icon will change to Standby mode.
5.2 System Shutdown
▪ To shut down the System turn the On-Off switch off.
▪ Turn the Main Power switch off at the end of the day.
▪ In case of an emergency, the System may be switched off instantly by pressing
the red Emergency Stop Button on the right side of the System’s front panel.
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Section 6: DiolazeXL Treatment Information
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Section 6: DiolazeXL Treatment Information
DiolazeXL hair removal treatment is based on principles of selective
photothermolisys. The light penetrates into the skin and is selectively absorbed by
melanin of the hair shaft. The absorbed energy is converted into heat, coagulating
the hair follicle. Multiple treatments are required for best results. White hairs are
resistant to the treatment due to scares pigmentation in the hair shaft. DiolazeXL
810nm is a universal hair removal for all skin types.
6.1 Instructions for Use
The Optimas System with the DiolazeXL 810nm Handpiece is intended for hair
removal and permanent hair reduction defined as the stable, long-term reduction in
hair counts at 6, 9, or 12 months following a treatment regime.
6.2 Contraindications
▪ Hair removal by lasers or intense pulse light sources can cause increased hair
growth in some individuals. Based upon currently available data, the highest risk
groups for this response are females of Mediterranean, Middle Eastern, and
South Asian heritage treated on the face and neck.
▪ Current or history of skin cancer, or current condition of any other type of
cancer, or pre-malignant moles.
▪ Pregnancy and nursing.
▪ Impaired immune system due to immunosuppressive diseases such as AIDS and
HIV or use of immunosuppressive medications.
▪ Patients with history of diseases stimulated by heat, such as recurrent Herpes
Simplex in the treatment area, may be treated only following a prophylactic
regimen.
▪ Poorly controlled endocrine disorders, such as diabetes, thyroid dysfunction,
polycystic ovary and hormonal virilization.
▪ Any active condition in the treatment area, such as sores, psoriasis, eczema, and
rash.
▪ History of skin disorders, keloids, abnormal wound healing, as well as very dry
and fragile skin.
▪ Severe concurrent conditions, such as cardiac disorders, sensory disturbances.
▪ Use of Isotretinoin (Accutane®) within 6 months prior to treatment.
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Section 6: DiolazeXL Treatment Information
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▪ Known skin photosensitivity or using drugs increasing skin photosensitivity.
▪ Diseases that may be stimulated by light, such as epilepsy, lupus and urticaria.
▪ Certain delay is recommended if other recent treatments like light, laser or RF
were performed on the same area.
▪ Fresh tan from sun, sunbeds or chemicals.
▪ Lasers can cause increased hair growth in some individuals with the highest risk
groups for being females of Mediterranean, Middle Eastern, and South Asian
heritage treated on the face and neck.
▪ Vitiligo.
▪ As per the practitioner's discretion, refrain from treating any condition which
might make it unsafe for the patient.
Do not treat the upper eyelids and the lips!
Do not treat over tattoo and permanent makeup!
6.3 Possible Adverse Effects
Possible adverse effects include but are not limited by: discomfort or pain, excessive
skin redness (erythema) and/or swelling (edema), damage to natural skin texture
(crust, blister, and burn), change of pigmentation (hyper- and hypo-pigmentation),
in-growing hairs and scarring.
Peri-follicular erythema and edema lasting for a few days after the treatment is a
desirable typical treatment end point.
The patient must understand the importance of pre-treatment and post-treatment
instructions and that failure to comply with these instructions may increase the
probability of complications.
Hair removal by lasers can cause temporal increased hair growth in some individuals.
Based upon currently available data, the highest risk groups for this response are
females of Mediterranean, Middle Eastern, and South Asian heritage treated on the
face and neck
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Section 6: DiolazeXL Treatment Information
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6.4 Pre-treatment Recommendations
During the patient’s first visit the treating attendant should:
▪ Complete or update the patient's medical and physical history.
▪ Exclude from treatment anyone with the listed contraindications.
▪ Determine why the patient is seeking treatment and what his/her expectations
are.
▪ Inform the patient about treatment arrangement, typical treatment results and
possible side effects and discomfort.
▪ Instruct the patient about the safety warnings.
▪ Advise the patient to avoid skin irritation or skin tanning. Sunscreen is advisable
during outdoor activity at daylight hours.
▪ The patient should discontinue any irritant topical agents for 2-3 days prior the
treatment.
▪ Stop anticoagulants 7-10 days prior to treatment, if medically permitted.
▪ Photograph the patient.
▪ Mark the treatment area.
▪ Clean the s parts that come in contact with the skin with 70% alcohol.
Treatment area should be shaved prior the treatment. Hairs may absorb
light and leave burn marks on the skin.
6.5 Tip Cleaning Instructions Prior to Use
▪ Clean the light guide with 70% alcohol absorbed pad for at least 30 sec.
▪ Leave it for complete drying.
6.6 Treatment Recommendations
1. Follow the Device Start-Up procedure from Section 5.
2. Ensure that the skin is clean.
3. Apply a thin layer of water-based clear gel to the treated area.
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Section 6: DiolazeXL Treatment Information
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Prior to using water-based gel, ensure that the container of ultrasound gel
has not passed the expiration date
4. Make a test-spot with to see epidermal end-points of perifollicular
erythema/edema. Use Strong Cooling while treating for better comfort and
safety. Perform the test spot in the area to be treated in a non-conspicuous
site and wait according to the Table below or current QRG (Quick Reference
Guide) to check the response.
5. Test and wait at least 15-30min and increase or decrease by 2J/cm² for skin
types I-IV. Wait 2-3 days and increase or decrease by 1-2J/cm² for skin types VVI.
6. Set treatment parameters. Typical treatment parameters are shown in the
table below; however, an individual adjustment is required:
7. Always start with a low settings level to check patient tolerance. Test, watch
epidermal response, and increase or decrease settings gradually. Darker skin is
safer to treat with Long pulse width. Lighter hair requires higher fluence to
reach the results. Stronger cooling allows better epidermis protection but may
compromise results on very superficial hair e.g. upper lip or Asian skin in
general. Reduce fluence on thin skin and in bone proximity along with a thicker
layer of gel. Consider primarily safety for selection of parameters.
8. Apply to the treated area ensuring a contact with pressure, depress foot switch
and press trigger button to deliver DiolazXL laser pulse.
Skin Type n
Type
Fluence
[ J/cm2]
Pulse Width
Cooling
Pulse Mode
I
16-26
Short
Strong
Single, 1pps, 2pps,
Glide
II
14-24
Short
Strong
Single, 1pps, 2pps,
Glide
III
12-22
Short
Strong
Single, 1pps, 2pps,
Glide
IV
10-20
Long
Strong
Single, 1pps, 2pps,
Glide
V
8-15
Long
Strong
Single, 1pps
VI
5-12
Long
Strong
Single, 1pps
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Section 6: DiolazeXL Treatment Information
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9. Move to adjacent site with small overlap and apply next pulses to cover all
treatment area. Pulse Mode may vary from Off (single pulse) or 1, 2 pulses per
second (pps) and Glide (5pps), restricted by certain fluence, as described in
Device Description in Section 4.
10. In a continuous mode, coordinate handpiece movement with the repetition
rate. Move handpiece to adjacent area only after the energy is delivered and
machine has indicated that the pulse is completed.
11. In a single mode (Pulse Mode at Off) - move Handpiece to adjacent spot and
apply next pulse to cover all treatment area.
12. If end-points are not obvious, or if gaps are apparent, perform another pass,
preferably in a different direction, when general erythema subsides.
Occasionally, a third pass on selected sites is applied on light skin. Ensure that
there is a delay of a few minutes between passes (after the whole area is
treated) before applying additional pass.
6.7 Treatment Schedule
The number of treatments is typically varied from 4-10 sessions every 4-8 weeks on
the face and every 6-12 weeks on the body.
▪ Lighter and deeper hair is more resistant and requires more treatment
sessions.
▪ Hair re-growth should be observed prior the treatment.
▪ Treatment should be concluded when the results are satisfactory to the
patient or according to the physician's discretion.
6.8 Post-treatment Recommendations
Following each treatment session, the physician should advise the patient on proper
care.
▪ Sun block should be used for 3 weeks following the treatment.
▪ Moisturizer may be applied after each treatment.
▪ Make-up may be applied immediately after facial treatment.
▪ During the first 2 days following treatment, care should be taken to prevent
trauma to the treated area: avoid hot baths, massage, etc. The skin should be
kept clean to avoid contamination or infection, any mechanical or thermal
damage to the area must be avoided.
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Section 7: Vasculaze Treatment Information
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Section 7: Vasculaze Treatment Information
Vasculaze is a diode laser at 1064nm wavelength that is intended to treat
predominantly blue reticular leg veins at a diameter of 1-4mm and depth of up to
5mm, including perforating veins. Due to the low absorption of 1064nm in
hemoglobin, 500-600nm lasers or IPL are a better choice to treat red telangiectasia
less than 1mm in diameter.
7.1 Indications for Use
The InMode System with the Vasculaze Handpiece is intended for the coagulation
and hemostasis of benign vascular lesions such as, but not limited to, port wine
stains, hemangiomas, warts, telangiectasias, rosacea, venous lake, leg veins, spider
veins, and poikiloderma of Civatte.
7.2 Contraindications
▪ Saphenous insufficiency.
▪ Current or history of skin cancer, or current condition of any other type of
cancer, or pre-malignant moles.
▪ Pregnancy and nursing.
▪ Impaired immune system due to immunosuppressive diseases such as AIDS and
HIV or use of immunosuppressive medications.
▪ Patients with history of diseases stimulated by heat, such as recurrent Herpes
Simplex in the treatment area, may be treated only following a prophylactic
regimen.
▪ Poorly controlled endocrine disorders, such as diabetes, thyroid dysfunction, and
hormonal virilization.
▪ Any active condition in the treatment area, such as sores, psoriasis, eczema, and
rash.
▪ History of skin disorders, keloids, abnormal wound healing, as well as very dry
and fragile skin.
▪ Severe concurrent conditions, such as cardiac disorders, sensory disturbances.
▪ Use of Isotretinoin (Accutane®) within 6 months prior to treatment.
▪ Known skin photosensitivity or using drugs increasing skin photosensitivity.
▪ Diseases that may be stimulated by light, such as epilepsy, lupus and urticaria.
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Section 7: Vasculaze Treatment Information
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▪ Certain delay is recommended if other recent treatments like light, laser or RF
were performed on the same area.
▪ Fresh tan from sun, sunbeds or chemicals.
▪ Vitiligo.
▪ As per the practitioner's discretion, refrain from treating any condition which
might make it unsafe for the patient.
Do not treat the upper eyelids and the lips!
Do not treat over tattoo and permanent makeup!
Severe varicosity will not benefit from the Vasculaze treatment.
7.3 Possible Adverse Effects
Possible adverse effects include but are not limited by: discomfort or pain, excessive
skin redness (erythema) and/or swelling (edema), damage to natural skin texture
(crust, blister, and burn), change of pigmentation (hyper- and hypo-pigmentation),
and scarring.
Erythema and edema along the vessels, lasting for up to 3 weeks after the treatment
is a desirable typical treatment end point.
The patient must understand the importance of pre-treatment and post-treatment
instructions and that failure to comply with these instructions may increase the
probability of complications.
7.4 Pre-treatment Recommendations
During the patient’s first visit the treating attendant should:
▪ Complete or update the patient's medical and physical history.
▪ Exclude from treatment anyone with the listed contraindications.
▪ Determine why the patient is seeking treatment and what his/her expectations
are.
▪ Inform the patient about treatment arrangement, typical treatment results and
possible side effects and discomfort.
▪ Instruct the patient about the safety warnings.
▪ Advise the patient to avoid skin irritation or skin tanning.
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Section 7: Vasculaze Treatment Information
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▪ Sunscreen is advisable during outdoor activity at daylight hours.
▪ The patient should discontinue any irritant topical agents for 2-3 days prior the
treatment.
▪ Stop anticoagulants 7-10 days prior to treatment, if medically permitted.
▪ Mark the treatment area along the vessels with a white marker.
▪ Clean the sapphire that comes in contact with the skin with 70% alcohol.
The treatment area should be shaved prior to the treatment. Hairs may
absorb light and leave burn marks on the skin.
7.5 Tip Cleaning Instructions Prior to Use
Clean the output window with 70% alcohol absorbed pad for at least 30sec and leave
it for complete drying.
7.6 Treatment Recommendations
1. Follow the Device Start-Up procedure from Section 5 - System Operation.
2. Ensure that the skin is clean.
3. Apply a thin layer of water-based gel to the treated area.
Prior to using water-based gel, ensure that the container of ultrasound gel
has not passed the expiration date
4. Make a test-spot with Normal/Strong Cooling to see epidermal end-points of
erythema/edema along vessels. If lesion is deep enough, change to Strong
Cooling while treating for better comfort and safety. Perform the test spot in
the area to be treated in a non-conspicuous site and wait according to the
Table below to check the response.
5. Test and wait a few minutes and increase or decrease by 2-5J/cm2 for skin
types I-IV. Wait longer and increase or decrease by 1-2J/cm2 for skin types
V-VI.
6. Set treatment parameters. Typical starting treatment parameters are shown in
the table below; however, an individual adjustment is required:
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Section 7: Vasculaze Treatment Information
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7. Always start with a low settings level to check patient tolerance. Test, watch
epidermal response, and increase or decrease settings gradually. Darker skin is
safer to treat with Long pulse width. Larger veins that are typically deeper
require higher fluence to be eliminated.
Stronger cooling allows better epidermis protection but may compromise
results on very superficial vessels. Reduce fluence on thin skin and in bone
proximity along with a thicker layer of gel.
8. Apply to the treated area ensuring a contact with minimal pressure, depress
foot switch and press hand-trigger button to deliver Vasculaze diode laser
pulse.
9. Move along the blood vessel with gaps up to 1cm until the full length is
covered. Pulse Mode may vary from Off (single pulse) or 1pps, depending on
speed of operator's hand movement and convenience.
10. If end-points of erythema and/or edema along the vessel are not obvious,
perform another pass. Occasionally, a third pass on selected sites is applied on
light skin. Ensure that there is a delay of a few minutes between passes (after
the whole area is treated) before applying additional pass.
When the site of perforating vertical feeder veins is not apparent, attempt
at joint points few vessels.
Skin
Type
Fluence
[J/cm2]
Pulse Width
Cooling
I
250-300
Short
Strong/Normal
II
225-300
Short
Strong/Normal
III
200-300
Short
Strong/Normal
IV
200-250
Long
Strong/Normal
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Section 7: Vasculaze Treatment Information
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7.7 Treatment Schedule
The number of treatments is typically varied from 1-3 sessions every 4-8 weeks.
Larger veins that are typically deeper require more sessions and longer time should
elapse between the treatment sessions.
Treatment should be concluded when the results are satisfactory to the patient or
according to the physician's discretion.
7.8 Post-treatment Recommendations
Following each treatment session, the physician should advise the patient on proper
care.
▪ Sun block should be used for 3 weeks following the treatment.
▪ Moisturizer may be applied after each treatment.
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Section 8: Lumecca Treatment Information
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Section 8: Lumecca Treatment Information
IPL Lumecca treatment is based on principles of selective photothermolysis. The light
penetrates into the skin and is selectively absorbed by lesion chromophore (melanin
or hemoglobin) having darker color than surrounding tissue. Absorbed energy is
converted into heat, coagulating the lesion which fades during a few weeks following
the treatment. Fine textural lesions like macro-pores, and fine lines may improve
along with the pigmented and vascular lesions in the skin photo-rejuvenation
process. Multiple treatment sessions may be required for best results.
8.1 Indications for Use
The Lumecca Handpieces are intended for treatment of superficial vascular and
pigmented lesions on skin type I to IV
8.2 Contraindications
▪ Current or history of skin cancer, or current condition of any other type of
cancer, or pre-malignant moles.
▪ Pregnancy and nursing.
▪ Impaired immune system due to immunosuppressive diseases such as AIDS and
HIV or use of immunosuppressive medications.
▪ Patients with history of diseases stimulated by heat, such as recurrent Herpes
Simplex in the treatment area, may be treated only following a prophylactic
regimen.
▪ Severe concurrent conditions, such as cardiac disorders, sensory disturbances.
▪ Any active condition in the treatment area, such as sores, psoriasis, eczema, and
rash.
▪ History of skin disorders, keloids, abnormal wound healing, as well as very dry
and fragile skin.
▪ Poorly controlled endocrine disorders, such as diabetes or thyroid dysfunction
and hormonal virilization.
▪ Use of Isotretinoin (Accutane®) within 6 months prior to treatment.
▪ Certain delay is recommended if other recent treatments such as light, laser or
RF were performed on treated area.
▪ Known skin photosensitivity or using drugs increasing skin photosensitivity.
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Section 8: Lumecca Treatment Information
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▪ Diseases that may be stimulated by light, such as epilepsy, lupus and urticaria.
▪ Vitiligo.
▪ Skin type V and VI and excessively tanned skin from sun, tanning beds or tanning
creams and sprays within the last two weeks.
▪ As per the practitioner's discretion, refrain from treating any condition which
might make it unsafe for the patient.
Do not treat the upper eyelids or the lips!
Do not treat over tattoo and permanent makeup and treat away from the
tattoo at least the width of the treatment tip!
Permanent hair reduction may occur in treated area.
Don’t treat over area with high density of hair follicles. Absorption of light
by hair follicles may cause skin adverse reaction.
8.3 Possible Side Effects
Possible adverse effects include but are not limited by: discomfort or pain, excessive
skin redness (erythema) and/or swelling (edema), damage to natural skin texture
(crust, blister, and burn), change of pigmentation (hyper- and hypo-pigmentation),
and scarring.
Erythema, lasting not longer than 24h is a typical skin reaction to the Lumecca
treatment.
The patient must understand the importance of pre-treatment and post-treatment
instructions and that failure to comply with these instructions may increase the
probability of complications.
8.4 Pre-treatment Recommendations
During the patient’s first visit the treating attendant should:
▪ Complete or update the patient's medical and physical history.
▪ Exclude from treatment anyone with the listed contraindications.
▪ Determine why the patient is seeking treatment and what his/her expectations
are.
▪ Inform the patient about treatment arrangement, typical treatment results and
possible side effects and discomfort.
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▪ Instruct the patient about the safety warnings.
▪ Advise the patient to avoid skin tanning for 3-4 weeks prior to the treatment and
use at least 30 SPF sunblock during outdoor activity at daylight hours.
▪ The patient should discontinue any irritant topical agents for 2-3 days prior the
treatment.
▪ Stop anticoagulants 7-10 days prior to treatment, if medically permitted.
▪ Photograph the patient.
▪ Mark the treatment area.
▪ Clean the handpieces parts that come in contact with the skin with 70% alcohol.
The patient may shave the area to be treated. Long and dark hair may
absorb light and leave burn marks on the skin.
8.5 Tip Cleaning Instructions Prior to Use
▪ Clean the light guide with 70% alcohol absorbed pad for at least 30 sec.
▪ Leave it to dry completely.
8.6 Test Spots
A small test spot with energy setting according to current QRG (Quick Reference
Guide) should be performed in a non-conspicuous area of the treatment site, prior to
the first complete session. Test spot is performed to establish the following
requirements:
▪ Confirm the patient's suitability for treatment:
– For skin type I – IV wait 10-15 minutes before assessing the skin
response.
– Do not treat skin type V-VI.
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8.7 Treatment Recommendations
1. Follow Device Start-Up Procedure from System Operation section.
2. Ensure that skin is clean.
3. Apply thin to thick layer of water-based gel to the treated area, mostly face.
Prior to using water-based gel, ensure that the container of ultrasound gel
has not passed the expiration date.
4. Basic treatment considerations:
– Treatment target is mainly face, or body, but not leg veins.
– Treatment targets are epidermal and junctional pigments, but not
dermal nevi and blood vessels 1-2mm deep and <0.5mm diameter (red
and purple), but not deeper and larger (blue and black).
– Set treatment parameters. Reduce ~20% fluence on thin sensitive skin
like neck or bony area like forehead. Further reduce fluence on thin
sensitive skin over bone like chest and hand dorsum and on off-face,
body areas, as well as on off-face areas, such as arms and legs.
– Use higher Fluence settings for vascular lesions than for pigmented
lesions.
– Use higher Fluence settings for lighter pigments than for darker.
– Use higher Fluence settings for larger and deeper veins than for
smaller and superficial ones.
– The Strong Cooling should protect the skin surface.
– Normal Cooling may be used after testing on very superficial and small
capillaries on light skin to avoid vessel constriction.
– Use a short pulse width for pigments on skin types I-II, occasionally III.
Can also start in Long Pulse then make additional pass in Short Pulse.
– Use a long pulse to prevent purpura or bruising in dense vascular areas
such as cheeks and chin.
– Do not treat moles or suspicious lesions. If unsure, consult a
dermatologist or do not treat.
– Treatment of facial melasma is controversial as it is a condition
controlled by hormones and may often reoccur. Furthermore, the
response is unpredictable, presenting no response, lesion lightening,
or even lesion darkening.
– In hair-bearing area there is a risk of hair loss, temporary or
permanent.
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Typical treatment parameters are shown in the table below:
Skin
type
Lesions type
Handpiece
[nm]
Fluence
[J/cm²]
Pulse
width
Cooling
I-II
Pigmented
lesions
515
8-12
Short
/Long
Strong
Vascular
lesions
515
12-16
Short
/Long
Strong
III-IV
Pigmented
lesions
580
6-12
Short
/Long
Strong
Vascular
lesions
580
10-16
Long
Strong
5. Always start with a low settings level to check patient tolerance to the
treatment parameters, test and then gradually increase energy fluence to
reach the results without compromising safety.
6. Apply hand piece to the treated area ensuring a full contact with slight
pressure (less pressure over superficial blood capillaries) and press trigger
button to deliver light pulse.
7. Perform a test spot in the area to be treated in a non-conspicuous site and
wait a few minutes to check the response. Wait a longer time on darker skin.
8. In a single mode (AutoRepeat Off), move Handpiece by stamping to adjacent
area without overlap and apply next pulse to cover all treatment area.
9. In a continuous mode, coordinate handpiece movement with the repetition
rate. Move handpiece to adjacent area only after the energy is delivered and
machine has indicated that the pulse is completed.
10. After the first pass if end-points are not obvious, perform another pass, after
10-15 minutes, longer for darker skin type IV, or when general erythema
subsides, preferably in a different light guide direction.
11. End-points are:
– Greying and/or darkening of pigments.
– Darkening of blood vessels.
– Erythema and/or edema around lesions.
– Tighter skin-look.
Lumecca is a very powerful applicator. Take care with the treatment
parameters!
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8.8 Post-treatment Recommendations
After each treatment session, the physician should advise the patient on proper care.
▪ Sun block should be used for 3 weeks following the treatment.
▪ Moisturizer may be applied after each treatment.
▪ Make-up may be applied immediately after the treatment.
8.9 Treatment Schedule
The number of treatments typically varies from 2-5 sessions every 3-4 weeks.
Pigmented lesions usually require less sessions than vascular lesions.
Treatment should be concluded when the results are satisfactory to the patient or
according to the physician's discretion.
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Section 9: Fractora Treatment Information
9.1 Fractional Skin Resurfacing
The Fractora Handpiece is designed for delivering RF energy to the skin surface in a
fractional manner with the energy applied to <10% of the total coverage area. The
energy is delivered to the skin through bipolar arrays of pins and results in localized
heating and ablation of the skin that is in direct contact with the pins. Ablation of the
skin promotes skin resurfacing while untreated skin between the pins promotes
faster healing of the tissue. There is also the contribution of non-ablative, noncoagulating dermal matrix heating that occurs in the skin that is not subject to
fractional ablation.
9.2 Indications for Use
Fractora Handpiece with 60 pin tip is designed for use in dermatological procedures
requiring ablation and resurfacing of the skin.
Fractora Handpiece with 24 pin tip is intended for use in Dermatologic and General
Surgical procedures for Electrocoagulation and Hemostasis. At higher energy levels
greater than 62, use of the applicator is limited to Skin Types I-IV.
9.3 Contraindications
▪ Pacemaker or internal defibrillator, or other metallic or electronic implant
anywhere in the body. The Handpiece should be used at least 1cm away from
cochlear implants in the ear.
▪ Permanent implant in the treated area such as metal plates, screws and metal
piercing or silicon, unless deep enough in the periosteal plane.
▪ Intra-dermal or superficial sub-dermal areas injected with
Botox®/HA/collagen/fat injections or other augmentation methods with biomaterial, before the product has been dissipated (up to 6 months), except Botox
after binding to the facial muscles (3-7 days). It is possible to treat sooner over
injectable products placed in the deep, periosteal plane, as soon as the area has
healed (1-3 weeks).
▪ Current or history of skin cancer, or any other type of cancer, or pre-malignant
moles.
▪ Pregnancy and nursing.
▪ Severe concurrent conditions, such as cardiac disorders or sensory disturbances.
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▪ Impaired immune system due to immunosuppressive diseases such as AIDS and
HIV or use of immunosuppressive medications.
▪ Patients with history of diseases stimulated by heat, such as recurrent Herpes
Simplex in the treatment area, may be treated only following a prophylactic
regime.
▪ Poorly controlled endocrine disorders, such as diabetes or thyroid dysfunction
and hormonal virilization.
▪ Any active skin condition in the treatment area, such as sores, psoriasis, eczema,
and rash.
▪ History of skin disorders, keloids, abnormal wound healing, as well as very dry
and fragile skin.
▪ History of bleeding coagulopathies.
▪ Any facial surgery performed within a year prior to treatment.
▪ Facial dermabrasion, facial resurfacing, or deep chemical peeling within the last
three months, if face is treated.
▪ Having received treatment with light, laser, RF, or other devices in the treated
area within 2-3 weeks for non-ablative procedures, and 6-12 weeks for ablative
fractional laser resurfacing (according to treatment severity) prior to treatment,
except special recommendations.
▪ Use of Isotretinoin (Accutane®) within 6 months prior to treatment.
▪ Use of non-steroidal anti-inflammatory drugs (NSAIDS, e.g., ibuprofen-containing
agents) one week before and after each treatment session, as per the
practitioner’s discretion.
▪ Treating over tattoo or permanent makeup.
▪ Treating over the lips.
▪ Treating over eyebrows or other hair bearing surfaces.
▪ Treat patients with skin types VI and dark VI with caution.
▪ Excessively tanned skin from sun, tanning beds or tanning creams and sprays
within the last two weeks.
▪ As per the practitioner's discretion, refrain from treating any condition that
might make it unsafe for the patient.
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9.4 Possible Adverse Side Effects
Possible adverse effects include but are not limited by: discomfort or pain, excessive
skin redness (erythema) and/or swelling (edema), damage to natural skin texture
(crust, blister, and burn), change of pigmentation (hyper- and hypo-pigmentation),
and scarring.
Erythema lasting not longer than 24h and edema for 1-3 weeks is a typical skin
reaction to the Fractora treatment.
Crusting from the ablated dots will exfoliate naturally after 1-3 weeks.
Occasionally, there is a potential low-level stimulation of branches of the facial nerve
and there will be some involuntary contraction of the underlying facial muscle. This is
transient and is not harmful, as the Fractora effect diminishes at the deeper level
where parts of the facial nerve lie above the muscles.
The patient must understand the importance of pre-treatment and post-treatment
instructions and that failure to comply with these instructions may increase the
probability of complications.
9.5 Pre-treatment Recommendations
During the patient’s first visit the treating attendant should:
▪ Complete or update the patient's medical and physical history.
▪ Exclude from treatment anyone with the listed contraindications.
▪ Determine why the patient is seeking treatment and what his/her expectations
are.
▪ Determine accurately the patients Fitzpatrick skin type.
▪ Inform the patient about treatment arrangement, typical treatment results and
possible side effects and discomfort.
▪ Instruct the patient about the safety warnings.
▪ Advise the patient to avoid skin irritation or intentional skin tanning. Sunscreen is
advisable when outdoors during daylight hours
▪ Asian patients and those with skin types IV-VI should be treated gradually by
bleaching products 6 weeks prior treatment and stop at least 48 hours prior
Fractora treatment to minimize risk of post inflammatory hyper-pigmentation.
▪ Prophylactic antiviral therapy should be prescribed for patients with history of
cold sores (Herpes Simplex) when treating around the mouth.
▪ Stop anticoagulants 7-10 days prior to treatment, if medically permitted.
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▪ Clean the treatment area.
▪ Apply anesthesia:
– Many patients can tolerate the treatment with no anesthesia at low
energy levels of 5-20 energy levels and sometimes more. Topical
anesthetic can be applied as needed prior to treatment.
– Topical for 30-45 min – limited to energy as tolerated by the patient
and may reach 40-62 energy levels, depending on the percent
numbing ingredients and patient sensitivity.
– A few patients require nerve block for higher energy, limited to central
face.
– Tumescent or IV sedation is applied usually when Fractora follows an
invasive procedure.
▪ Cooling methods, such as air cooling, sterile ice-packs, or sterile latex gloves filled
with ice, help patient comfort during and after treatment.
The patient should shave the area to be treated. Long and dense hairs
prevent electrode contact with the skin’s surface.
9.6 Tip Cleaning Instructions Prior to Use
▪ Clean the tip with 70% alcohol absorbed pad for at least 30sec.
▪ Leave it for complete drying.
▪ Before each use of the Fractora Handpiece and tip, they must be checked for
integrity and proper cleaning and drying.
The Fractora tip is single use only!
9.7 Test Spots
A small test spot should be performed in a non-conspicuous area of the treatment
site, prior to the first complete session. Test spot is performed to establish the
following requirements:
▪ Confirm the patient's suitability for treatment:
– For skin types I – III wait 10-15 minutes before assessing the skin
response.
– For skin types V-VI wait 2-3 days if energy level <30 is used and 7-10
days if energy level >30 is used.
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▪ Establish and confirm treatment parameters: if the desired end-point of
erythema and edema – in a tip-shaped pattern – has not been achieved within
10-15 minutes, increase the RF energy. If the response is excessive, decrease the
parameters.
▪ Low energy levels of 10-25 may be tolerated after topical anesthesia application.
Energy levels of 25-40 may require nerve block or tumescent and high energy
levels of 40-62 may call for tumescent or IV sedation.
9.8 Treatment Recommendations
1. Apply the necessary means of anesthesia. If topical, make sure that it is
cleaned off the face before treatment and the skin is dried with alcohol 70%.
2. Ensure that skin is clean and dried with alcohol 70%.
3. Take an alcohol cleaned and dry tip and connect it to the Handpiece in the
groove.
4. Connect Handpiece to the System.
5. Follow Device Start-Up Procedure from System Operation section.
6. Refer to the most current QRG (Quick Reference Guide)
7. Set treatment parameters. Typical treatment parameters are shown in the
table below:
Clinical
Indications
Tip
Treatment
Area
RF
Energy
Level
No.
Sessions
Weeks
between
Sessions
Down
Time
Days
Superficial
- texture,
tone, very
fine lines
60
Soft tissue
10-25
3-5
1-4
0-1
Bony area
5-20
Moderate texture,
tone, fine
lines
60
Soft tissue
25-30
2-3
4-5
2-3
Bony area
20-30
Deep texture,
tone, fine
lines, fine
vessels,
wrinkles,
acne scars
60
Soft tissue
30
1-2
5-6
7-10
Bony area
25-30
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Clinical
Indications
Tip
Treatment
Area
RF
Energy
Level
No.
Sessions
Weeks
between
Sessions
Down
Time
Days
Deep
ablation of
wrinkles,
scars
24
NonCoated
Soft tissue
25-40
1-3
3-6
2-5
Deep
ablation of
wrinkles,
scars
24
NonCoated
Bony area
20-30
1-3
3-6
1-2
Tightening
lax skin and
dark skin
ablation
24
Coated
Soft tissue
15-40
1-3
2-3
2-5
Tightening
lax skin and
dark skin
ablation
24
Coated
Bony area
15-25
1-3
2-3
1-2
The approval and availability of the various Fractora tips may differ in
different countries.
8. Basic treatment consideration:
– All tips may be applied to skin type I-IV. Skin types IV-VI are better
treated by 24 Coated pin tip.
– 60 pin tip energy is limited to 30 and repetition rate of 1pps in auto
pulse mode.
9. Always start with a low energy level, test and observe the skin's response
before increasing the energy.
10. The deeper the lesion, the higher the energy. However, this consideration is
limited according to patient tolerance, the anesthetic method used, and the
affordable down time.
11. On sensitive thin skin area, such as lower eyelid, apply lower parameters with
more passes, rather than higher parameters in one pass. It is also applicable to
any facial area for new users. Use lower energy (~20%) for thin skin like neck or
bony area like forehead. When working on thin skin over bone, such as hand
dorsum or chest, further reduce energy (~20%).
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12. Treat dark skin (V-VI) with the 24 coated pin tip, restrict energy, starting at
energy level 15 or lower, adding 5 levels each visit (every 3-4 weeks) to a
maximum of energy level 40 on soft tissue, and energy level 25 over bone,
preferably following bleaching regimen.
13. Apply the Fractora Handpiece to the treated area ensuring a contact with
pressure to minimize discomfort, and press the Footswitch to deliver RF energy
14. Move Handpiece to the adjacent area and press Footswitch again in the
SINGLE mode or adjust the repetition rate to the speed you move the tip to
adjacent site.
15. Move to adjacent areas with no overlapping of side-electrodes (30-50%
overlap).
16. Occasionally, additional 1-2 passes may be applied to reinforce results on the
full area or on selected spots. Gaps may be treated after the full area is done.
17. The endpoint is substantial erythema and edema, visible ablative craters, and
burnt tissue smell often accompanied by tingling heat sensation.
9.9 Treatment Schedule
The number of treatment sessions depends on the individual patient and treatment
aggressiveness and may vary from 1-5 sessions. Treatments are typically repeated
every 3-6 weeks.
It is recommended to schedule follow-up session 2-3 days after the treatment to
ensure safe healing process.
Treatment should be concluded when the results are satisfactory to the patient or
according to the physician's discretion. Generally, 3-5 sessions are needed for mild to
moderate depth settings. It is not typical to perform more than five consecutive
sessions however more sessions can be performed as per physician discretion. In
some instances, 1-2 sessions may be sufficient.
9.10 Post-treatment Recommendations
After each treatment session, the physician should advise the patient on proper care.
▪ Cool the skin for 10-20 min.
▪ Emollient cream or occlusive dressing could be applied to the treatment area.
▪ Alternatively, prophylactic antibiotic treatment may be prescribed for 1-3 days
post treatment. Patient is to contact the physician if there is any indication of
infection, excessive swelling, redness, undue pain, or any other unusual or
untoward symptom.
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▪ Tiny scabs may appear after 1-3 days and stay for several days following the
treatment. The scabs should not be touched or scratched even if they itch and
should be allowed to flake off naturally.
▪ Blisters may be treated with a prescribed antibiotic ointment or burn treatment
cream as per physician's discretion.
▪ During the first two days following treatment the skin should be kept clean to
avoid contamination or infection; any mechanical or thermal damage to the area
must be avoided.
▪ Prophylactic antiviral therapy should be continued for patients with history of
cold sores (Herpes Simplex) when treating around the mouth.
▪ Moisturizer may be applied 24-72 hours after each treatment and then should be
applied regularly throughout the course of the treatment. Make-up may be
applied only 24-72 hours after each treatment session. Generally, 24 hours after
treatment, patients may use regular soaps, but not scrub soaps or exfoliates.
▪ The patient should use a high-factor sunscreen (at least 30 SPF) and protect the
treated area from over-exposure to sunlight for at least one month after the
treatment, starting 24-72 hours post treatment. Excessive tanning of any sort
(sun exposure, tanning beds, and artificial tanning lotions) is not allowed in the
treated areas during the entire course of the treatment.
▪ For Asian patients and skin types IV and V, a prescription or compounded
bleaching regimen may be prescribed by the physician for 6-12 weeks, 2-3 times
a week following the healing of treatment area (typically 7 days) to minimize risk
of post inflammatory hyper-pigmentation. It should be stopped 48-72 hours
before another Fractora session.
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Section 10: Forma Treatment Information
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Section 10: Forma Treatment Information
10.1 Indications for Use
The Forma Handpiece is intended for use in dermatologic procedures for noninvasive
treatment of mild to moderate facial wrinkles and rhytids. Hand pieces is indicated
for the temporary relief of minor muscle aches and pain, temporary relief of muscle
spasm, and temporary improvement of local blood circulation.
10.2 Contraindications
▪ Pacemaker or internal defibrillator, or any other metallic or electronic implant
anywhere in the body. The Handpiece should be used at least 1cm away from
cochlear implants in the ear.
▪ Permanent implant in the treated area such as metal plates, screws and metal
piercing, silicone implants or an injected chemical substance, unless deep enough
in the periosteal plane.
▪ Intra-dermal or superficial sub-dermal areas that have been injected with
HA/collagen/fat injections or other augmentation methods with bio-material
during last 6 months.
▪ Current or history of skin cancer, or current condition of any other type of
cancer, or pre-malignant moles.
▪ Severe concurrent conditions, such as cardiac disorders, sensory disturbances,
epilepsy, uncontrolled hypertension, and liver or kidney diseases.
▪ Pregnancy and nursing.
▪ Impaired immune system due to immunosuppressive diseases such as AIDS and
HIV, autoimmune disorders or use of immunosuppressive medications.
▪ Patients with history of diseases stimulated by heat, such as recurrent Herpes
Simplex in the treatment area, may be treated only following a prophylactic
regimen.
▪ Poorly controlled endocrine disorders, such as diabetes or thyroid dysfunction
and hormonal virilization.
▪ Any active condition in the treatment area, such as sores, psoriasis, eczema, and
rash.
▪ History of skin disorders, keloids, abnormal wound healing, as well as very dry
and fragile skin.
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▪ History of bleeding coagulopathies, or use of anticoagulants in the last 10 days,
as per the practitioner discretion.
▪ Facial dermabrasion, laser resurfacing and deep chemical peeling within the last
3 months prior Forma treatment.
▪ Having received treatment with light, laser, RF, or other devices in the treated
area within 3 months, or before complete healing.
▪ Any surgical procedure in the treatment area within the last 3 months or before
complete healing.
▪ Use of Isotretinoin (Accutane®) within 6 months prior to treatment.
▪ As per the practitioner's discretion, refrain from treating any condition which
might make it unsafe for the patient unsafe for the patient.
10.3 Possible Adverse Effects
Possible side effects include but are not limited to:
▪ Discomfort or pain, excessive skin redness (erythema) and/or swelling (edema),
damage to natural skin texture (crust, blister, burn), change of pigmentation
(hyper- and hypo-pigmentation), scarring.
▪ Erythema and edema lasting not longer than 24h is typical skin reaction to the
treatment.
▪ The patient must understand the importance of pre-treatment and post-
treatment instructions and that failure to comply with these instructions may
increase the probability of complications.
10.4 Handpiece Cleaning Instructions Prior to Use
These cleaning instructions are for clinical use only.
The following processes are validated for the Forma Handpiece when used in
accordance with the instructions provided for cleaning products and/or processes.
Any deviation from said instructions or the cleaning agents listed below may impact
the performance or durability of the product and is prohibited. Review those
instructions for additional warnings and cautions.
We recommend the usage of the following cleaning agent that was tested in our
company for material compatibility as 70% alcohol solution.
Cleaning Procedure:
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▪ Thoroughly clean the Handpiece with 70% alcohol absorbed pad for at least 30
sec and repeat as necessary.
▪ Leave it for complete drying.
Pre-Use Check:
Before each use of the Handpiece, the device must pass the following:
▪ Check to ensure proper cleaning and drying of the Handpiece.
▪ Inspect all components of the Handpiece for visible damage.
10.5 Pre-treatment Recommendations
During the patient’s first visit the treating attendant should:
▪ Complete or update the patient’s medical and physical history.
▪ Exclude from treatment anyone with the listed contraindications.
▪ Determine why the patient is seeking treatment and what his/her expectations
are.
▪ Inform the patient about treatment arrangement, typical treatment results and
possible side effects and discomfort.
▪ Instruct the patient about the safety warnings.
▪ The patient should discontinue any irritant topical agents for 2-3 days prior to
treatment and if medically permitted, anticoagulants should be stopped 1-2
weeks prior treatment.
▪ Clean the face, remove creams/lotions and makeup, and dry the skin.
▪ Photograph the patient.
▪ Mark the treatment area.
▪ Clean the handpiece’s parts that come in contact with the skin with 70% alcohol.
Long and dense hairs may affect the treatment and may be shaved
according to the physician’s discretion.
10.6 Treatment Recommendations
1. Ensure that the skin is clean and dry.
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2. Follow the Device Start-Up procedure from Section 5.
3. Set treatment parameters according to current QRG (Quick Reference Guide).
Suggested facial treatment parameters for Forma are shown in the table
below:
Facial Treatment
Zone
RF
Energy
Level
Cut-Off Temperature [oC]
Gel
Thick soft skin e.g.
Cheeks, nasolabial
folds, and jawline
40-50
As high as tolerable
Starting at 40oC
Thin layer
2-3mm
Thin skin e.g. neck
35-40
As high as tolerable
Starting at 40oC
Thin layer
2-3mm
Thin skin over
bone e.g.
forehead, hand
25-35
As high as tolerable
Starting at 40oC
Thick layer
3-4mm
4. Any combination of treatment parameters should be according to skin
response and patient tolerance.
5. Always start with low settings and observe the skin's reaction and patient
comfort before increasing the RF energy.
6. Air condition directed at the patient treated area may reduce the skin surface
temperature in 1-2oC, and cut-off temperature should be reduced accordingly.
7. Divide facial and neck treatment area to zones as shown in figure below:
8. Neck may be 2 zones for under-chin or 4 zones with neck as well.
9. Users may prefer other ways to subdivide the face.
10. Body zone is ~12x12cm unless the area is smaller (~8x8cm).
11. Mark treatment zones prior to beginning treatment while patient is standing.
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Figure 10-1: Recommended Forma Facial and Neck Treatment Zones
12. Apply 2-4mm clear ultrasound gel (not oil) to the treated zone and to adjacent
zone that can serve as a warm gel reservoir for replenishing gel in the
treatment zone with minimal delay.
Prior to using water-based gel, ensure that the container of ultrasound gel
has not passed the expiration date.
13. RF is continuous in Repeat mode and stops every 30sec in Single mode. Always
work in Repeat mode.
14. Assume full contact of Handpiece with the skin with a slight pressure.
15. Use your free hand to flatten and stretch treatment area if needed for
complete contact and smooth movement.
16. Press the Footswitch and initiate the RF energy.
17. Move the Handpiece in circular movements or back and forth with gentle
pressure over the full treated zone to reach uniform skin heating. Movement
should be constant and its amplitude should be at least double of Handpiece
spot size to avoid hot spots.
18. Continue to treat the area in this fashion. Always start with a low setting level
to check the patient’s tolerance to the treatment parameters and increase the
settings gradually.
19. Apply multiple passes to maintain the desired temperature during ~5-7min on
face and neck. If cut-off temperature is <41°C, maintain the temperature for
additional 1-3min per zone.
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20. After treating the zone, move to the next zone.
21. For excessive heat sensation, you may increase the movement speed, reduce
the RF power and lastly, reduce the cut-off temperature for patient comfort. If
this does not help, stop the treatment and move to the next zone.
22. When skin temperature reaches cut-off limit in ~2min, continue to treat for 15-
30min/zone the longer, the better. If cut-off temperature is <41°C, maintain
the temperature for additional 1-3min.
23. Repeat treatment for the other zones, following the same protocol.
24. Slight erythema and edema is a typical immediate response. However, when
there is excessive skin response (erythema and edema), stop treatment and
move to the next zone.
The skin should be observed for excessive erythema or edema. If observed,
stop the treatment and move to the next treatment zone.
Asian skin is typically thicker and more fibrotic than Caucasian skin, hence
occasionally higher energy, smaller zones, longer treatment and more
sessions (all or part) may be required.
10.7 Treatment Schedule
▪ The number of treatments is typically 8 sessions, once weekly and may vary
individually. Some patients may need 10 weekly sessions.
▪ Longer treatment time in each treatment may help reduce the number of
sessions.
▪ Thicker skin that is more fibrotic may require more sessions.
▪ Single maintenance sessions may be needed every 1-3 months.
10.8 Post-treatment Recommendations
▪ Skin cooling is NOT recommended.
▪ The patient should avoid very hot water for 2 days after the treatment.
▪ The patient should avoid scrubbing, pinching and etc. of the treated area.
▪ Moisturizer and makeup may be applied to the skin surface immediately post
treatment.
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▪ After each treatment session, the patient should be advised to contact the
physician if there is any indication of infection, excessive swelling, redness, pain,
or any other unusual or untoward symptom.
▪ The Handpiece should be cleaned from the gel and disinfected by 70% alcohol.
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Section 11: System Maintenance
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Section 11: System Maintenance
11.1 Maintenance & Frequency
The following list suggests how often each of the maintenance procedures should be
performed by the operator.
11.2 Before and after each treatment
Wipe the device with a damp soft cloth. The Handpiece elements that are in contact
with the skin should be disinfected with 70% alcohol between patients, as described
in detail for each handpiece in “Handpiece Cleaning Instruction Prior to Use”. For
applications that require gel (DiolazeXL, Vasculaze, Lumecca and Forma), remove the
gel before cleaning.
11.3 Once a Week
Clean the System at least once a week. Turn the System off and wipe all surfaces. Be
careful not to spill any liquids on the System.
Clean the Dust Cover. In dusty environments or desert regions, it should be checked
daily.
11.4 Once a Month
Replace the cooling water at least once a month. Follow the instruction of “Draining
Water” and “Filling Water” below.
11.5 Once a Year
By the operator:
▪ Replace the Deionizer Cartridge and Capsule Filter at least once a year. Follow
the “Replacing the Deionizer Cartridge” and Replacing the Capsule Filter”
instructions below.
▪ Replacement Deionizer Cartridge and Capsule Filter can be purchased by your
local service center.
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By authorized service personnel only:
▪ System and Hand pieces full test and calibration is required to be done. Please
make sure to contact your local service center to perform this process.
Failure to replace your filters can lead to serious malfunctions of the
laser/IPL Handpieces!
11.6 Filling Water for DiolazeXL, Vasculaze and Lumecca
Optimas System, as well as, DiolazeXL, Vasculaze and Lumecca Handpieces are
shipped without water. When filling water upon installation, distilled water must be
used and failure to do so will void the service warranty.
During water filling, air bubbles can form inside the hoses which may cause water
flow issues. This instruction will help prevent this from occurring.
1. Open the back cover and take out the bottle.
2. Unscrew the water bottle cap (Figure 11.1).
3. Slowly pour distilled water into the bottle while water filter and tube are inside
the bottle to prevent over pouring (Figure 11.2).
Figure 11-1: Water Bottle Cap
Figure 11-2: Distilled Water
Filling
Figure 11-3:Water Bottle in
Bracket
4. Fill the bottle up to the maximum level.
5. Close the bottle cap and insert the bottle at the back of the System
(Figure 11.3).
6. Connect any DiolazeXL, Vasculaze or Lumecca 515 or 580 Handpiece.
7. Turn the System ON.
8. Select “Utilities” on the Main Menu (Figure 11.4).
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9. Select “Water Drain/Fill” (Figure 11.5).
10. Pressing the UP arrow will activate the pump and count down from 600
seconds (10 minutes) to 0 seconds (Figure 11.6).
Figure 11-4: Menu Screen
Figure 11-5: Utilities Screen
Figure 11-6: Time Counter Water Pump Current Value
11. After 300 seconds (while the pump is working), unscrew the plastic cap on the
side of the Capsule Filter counterclockwise to release air. Afterwards, screw
the cap clockwise to close it (Figure 11.7). Ensure that no water is leaking.
Figure 11-7: Capsule Filter with Plastic Cap
12. Pressing the Down arrow will stop the Water Pump.
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13. Repeat steps 2 to 5 since the System and Handpiece will take some of the
water.
14. Turn the System OFF.
15. Connect additional Handpieces.
16. Repeat Steps 6 to 12 for each Handpiece.
17. Ensure the water level is checked periodically.
11.7 Draining Water for VASCULAZE, DIOLAZEXL and LUMECCA
For shipping and storage, the Optimas Systems and optical Handpieces must be
drained of water during freezing temperature. Failure to do so will void the service
warranty. Frozen water in the System and Handpiece hoses can lead to damages
1. Open the back cover and take out the bottle.
2. Unscrew the water bottle cap and slowly remove it from the bottle
(Figure 11.8).
Figure 11-8: Water Bottle with Deionizer
Cartridge
Figure 11-9: Water Bottle in Drain Position
3. Empty the bottle.
4. Place the bottle inside the chamber with the black hose outside the bottle
(Figure 11.9).
5. Connect the available optical Handpieces, one by one.
6. Turn the System ON.
7. Select “Utilities” on the Main Menu (Figure 11.4).
8. Select “Water Drain/Fill” (Figure 11.5).
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9. Pressing the UP arrow will activate the pump and count down from 600
seconds down to 0 seconds (Figure 11.6).
10. Pressing the DOWN arrow will stop the water pump.
11. Repeat Steps 5 to 9 for draining any remaining optical Handpiece.
12. Observe the reservoir; when no more water is pouring out turn off the System.
11.8 Draining the Laser/IPL Handpieces with the Water Draining
Tool
When only applicators are shipped or stored, follow applicators draining instructions
below. It is possible to connect them to the System and perform the draining
procedure, as above. It is also possible to use the InMode Water-draining tool
(Figure 11.10).
Figure 11-10: Water-Draining Tool
The DiolazeXL, Vasculaze and Lumecca Handpieces may be damaged in cold
(freezing) temperatures that occur during transportation or the local storage
environment. In cold climates, especially during the winter, systems and handpieces
may be damaged during transportation or storage when exposed to freezing
temperature.
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To drain the Handpiece:
1. Hold the water draining tool's connector and insert the Handpiece's connector
with the label at a 90° counter-clockwise angle (Figure 11.11), and twist it 90°
to the right, such that the label is straight.
Figure 11-11: Connecting the Handpiece to the Water Draining Tool
2. Hold the Handpiece and draining tool over a sink and start pumping air
through the Handpiece until no more water drains out.
3. Disconnect the Handpiece from the water draining tool.
Damage to the System or Handpieces by frozen water will not be covered
under System's warranty.
Only InMode draining mechanical hand pumps (InMode P/N AT604837x)
could be used to drain DiolazeXL, Vasculaze and Lumecca Handpieces.
To order the water drain tool contact our Service department.
11.9 Replacing the Deionizer Cartridge
For safety, and proper System performance, replace the cooling water with fresh
distilled water only.
To remove the Deionizer Cartridge:
1. Drain the water from the System following “Draining Water” procedure.
2. Turn the System off.
3. Push the slide latch of the bottle door down and remove the door.
4. Holding the bottle cover with one hand, loosen the bottle by turning it
clockwise.
5. Disconnect the Deionizer Cartridge from the water hoses by pressing the
Release Button on the upper part of the Deionizer (Figure 11.8).
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To install a new Deionizer Cartridge:
1. Connect the water hose into the Deionizer filter until is securely locked.
2. Remove the water bottle from the compartment, pour out the distilled water
from the bottle according to “Draining Water” procedure and wash it with new
fresh water.
3. Fill 1 liter of distilled water into the bottle and return it to its compartment.
Perform “Filling Water” procedure as described above.
11.10 Replacing the Capsule Filter
For safety, and proper System performance, replace the cooling water with fresh
distilled water only.
To remove the Capsule Filter:
1. Drain the water from the System following “Draining Water” procedure
2. Turn the System off.
3. Push the slide latch of the bottle door down and remove the door.
4. Holding the Capsule Filter with one hand, loosen the filter by pressing the
upper black quick connector and pulling the filter out of the water hose (Figure
11-12 left).
5. Holding the Capsule Filter with one hand, loosen the filter by pressing the
lower black quick connector and pulling the filter out of the water hose
(Figure 11-12 right).
Figure 11-12: Upper (Left) and Lower (Right) Filter Quick Connectors
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To install a new Capsule Filter:
1. Hold the Capsule Filter when the arrow on the filter body pointing upwards.
2. Push the lower system water hose into lower filter’s quick black connector as
much as possible (Figure 11.12 right).
3. Push the upper system water hose into upper filter’s quick black connector as
much as possible (Figure 11.12 left).
4. Remove the water bottle from the compartment, pour out the distilled water
from the bottle according to “Draining Water” procedure and wash it with new
fresh water.
5. Fill 1 liter of distilled water into the bottle and return it to its compartment.
Perform “Filling Water” procedure as described above.
11.11 Air Filter
Systems marked by the Service Revisions listed in the table below are equipped with
new air filters. The Filters are intended to reduce dust and debris entering and
accumulating inside the System. Dust and debris may affect internal heat exchanges
and the performance of other components.
Platform Description
Part Number
Service Revision
InMode II
AG606666A
B04
Optimas
AG606991A
B04
Triton
AG606992A
A02
Dust filter are located on inside back over door (Figure 11-13).
Figure 11-13: Back Cover Door with Dust Filter
Air Filter Maintenance
• Dust Filter must be to be cleaned once a week. In dusty environments or desert
regions, it should be checked daily.
• Replace the Dust Filter if damaged.
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Cleaning method
• Remove back cover door and wash it under tap water until filter net is clean from
a dust. Air pressure can used carefully if available.
• Shake and dry the back cover door before use.
• Return the back cover door when dry.
Dust Filter ordering
• In order to add a back cover with Dust Filter to existing Systems, order the parts
as listed in the table.
• For Systems which already have a support for the back door, order a Mesh for
Cabinet Back Cover (part number MM607749X).
Platform
Item Description
Part Number
AG606666A InMode II
White Back Cover door
with Dust filter
AS607830X
AG606991A Optimas
AG606992A Triton
Black back Cover door
with Dust Filter
AS607831X
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Section 12: Troubleshooting
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Section 12: Troubleshooting
The Optimas System provides monitoring of all critical parameters to ensure safety of
patient and user. If any of the following faults are detected by the System
automatically goes to STAND BY mode.
12.1 Description of Faults with All Handpieces
Problem
Description and Checks
System did not turn on
▪ Check power cord connection.
▪ Check that main switch on rear panel is on.
▪ Check that On/Off switch on front panel is on.
▪ Check Emergency button not pressed.
▪ Check fuses on back panel of the System.
▪ Call Technical Service if problem persists.
System shuts down by
itself
▪ Check power cord connection.
▪ Check fuses on back panel of the System.
▪ Check Emergency button not pressed.
▪ Call Technical Service if problem persists.
Checksum
▪ The software was not loaded properly from
software plug.
▪ Check the plug connection and reboot the
System.
▪ Call Technical Service if the problem persists.
Fault H8002 - Handpiece is
not connected
▪ Check the connection of the Handpiece.
▪ Replace the Handpiece.
▪ Call Technical Service if the problem persists.
Fault H8005, H800F, H8010
– System Memory Fault
Call Technical Service if the problem persists.
Fault H8601 – Distributor
Card Connection Fault
Call Technical Service if the problem persists.
Fault H8609 – Water
Temperature Fault
Call Technical Service if the problem persists.
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Problem
Description and Checks
Fault H800E- System
Incompatible Software
Version
Call Technical Service if the problem persists.
Fault H800E- System
Incompatible Software
Version
Call Technical Service if the problem persists.
Fault H800F- System
Memory Fault
Call Technical Service if the problem persists.
Fault H8010- System
Memory Fault
Call Technical Service if the problem persists.
Faults H83XX, H84XX,
H82XX
Call Technical Service if the problem persists.
Faults H86XX Water Flow
Fault
▪ Open cover on the back panel and check if
water level is within defined limits.
▪ Call Technical Service if the problem persists.
Faults H8003, H8006,
H8007 - RF Related Faults
Call Technical Service if the problem persists.
Faults H8401, H8410,
H8420, H8421, H8422,
H8430, H8431, H8481 - IPL
Related Faults
Call Technical Service if the problem persists.
Faults H8202, H8210,
H8211, H8220-H8229,
H8222 - Laser Related
Faults
Call Technical Service if the problem persists.
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Section 13: System Specifications
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Section 13: System Specifications
Input Power
Main Line Frequency (nominal)
50-60Hz
Input Voltage (nominal)
100-240VAC
Input Current (rms)
12A
Operating Parameters
Ambient Temperature Range
15 – 30°C [59 – 86°F]
Relative Humidity
30% to 80%, non-condensing
Atmospheric Pressure
90 - 110kPa
Warm-up Time
If transported or stored at temperatures outside
the operating temperature range, allow one hour
for the device to reach room temperature before
use.
Transport and Storage
Ambient Temperature Range
-20– 65oC [-4 – 14°F]
Relative Humidity
0% to 80%, non-condensing
Atmospheric Pressure
50 to 110kPa
Dimensions
System
46cm W x 46cm
D x 100cm H
[18.2’’ W x 18.2’’ D x
40’’ H]
Handpiece Cable
170; 280cm L
[67; 110`` L]
Weight
System
32.000kg
[70.548lb]
DiolazeXL Applicator
0.450kg
[0.991lb]
Vasculaze Applicator
0.420kg
[0.925lb]
Lumecca Applicator
0.575kg
[1.268lb]
Fractora Applicator
0.100kg
[0.220lb]
Forma Applicator
0.110kg
[0.243lb]
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Section 13: System Specifications
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DiolazeXL Output Parameters
Wavelength
810nm
Fluence
5-40 J/cm²
Pulse width (duration)
Short/Long
Light guide cooling
Strong: 7oC, Normal: 12oC
Spot size
11mm x 27.5mm
Vasculaze Output Parameters
Wavelength
1064nm
Fluence
100-300J/cm²
Pulse width (duration)
Short/Long
Light guide cooling
Strong: 7oC, Normal: 12oC
Spot size
3mm x 4mm
Lumecca Output Parameters
Wavelength
515 – 1200nm (SR 515)
580 – 1200nm (SR 580)
Fluence
5 – 30J/cm²
Pulse width (duration)
Short/Long
Light guide cooling
Strong: 15oC, Normal: 22oC
Spot size
10mm x 30mm
Fractora Output Parameters
RF Energy
5 – 62 energy levels
Frequency
1MHz
Forma Output Parameters
RF Energy
20 – 62 energy levels
Frequency
1MHz
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13.1 Output Power Curves
The curves that follow depict the changes for each RF mode at specific power
settings.
Figure 13-1: Fractora 24 Pin Output Power versus Impedance
Figure 13-2: Fractora 60 Pin Output Power versus Impedance
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Figure 13-3: Forma Output Power versus Impedance
13.2 EMC Safety
The device has been tested and found to comply with the limits for the medical
devices to the IEC 60601-1-2. These limits are designed to provide reasonable
protection against harmful interference in a typical clinical installation. This device
generates uses and can radiate radio frequency energy. If not installed and used in
accordance with the instructions, may cause harmful interference to other devices in
the vicinity. However, there is no guarantee that the interference to other devices,
which can be determined by turning the device off and on, is caused by this
instrument.
The user is encouraged to try to correct the interference by one or more of the
following measures:
▪ Reorient or relocate the receiving device.
▪ Increase the separation between the devices.
▪ Connect the device into an outlet on a circuit different from that which was
previously used.
▪ Consult InMode service personnel for help.
Interference to the device may be caused by portable and mobile RF communication
equipment. In case of an interruption, beware of such a device in the vicinity.
▪ Use of the System with any accessory, transducer or cable other than those
specified may result in increased EMISSIONS or decreased IMMUNITY than those
specified.
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▪ The System should not be used adjacent to or stacked with other equipment. If
adjacent or stacked use is necessary, the System should be observed to verify
normal operation in the configuration in which it will be used.
Guidance and manufacturer’s declaration – electromagnetic emissions
The Optimas System is intended for use in the electromagnetic environment specified below. The
customer or the user of the Optimas should assure that it is used in such an environment.
Emissions test
Compliance
Electromagnetic environment – guidance
RF emissions CISPR 11
Group 1
The System uses RF energy only for its
internal function. Therefore, its RF
emissions are very low and are not likely
to cause any interference in nearby
electronic equipment.
RF emissions CISPR 11
Class A
The System is suitable for use in all
establishments other than domestic and
those directly connected to the public
low-voltage power supply network that
supplies buildings used for domestic
purposes.
Harmonic emissions
IEC 61000-3-2
Complies
Voltage fluctuations/
flicker emissions
IEC 61000-3-3
Complies
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Guidance and manufacturer’s declaration – electromagnetic immunity
The System is intended for use in the electromagnetic environment specified below. The
customer or the user should assure that it is used in such an environment.
Immunity test
IEC 60601 test level
Compliance
level
Electromagnetic
environment –
guidance
Electrostatic
discharge
(ESD) IEC
61000-4-2
± 6 kV contact
± 8 kV air
± 6 kV contact
± 8 kV air
Floors should be wood,
concrete or ceramic tile.
If floors are covered
with synthetic material,
the relative humidity
should be at least 30 %.
Electrical fast
transient/burst
IEC 61000-4-4
± 2 kV for power
supply lines ± 1 kV
for input/output
lines
± 2 kV for
power supply
lines
Mains power quality
should be that of a
typical commercial or
hospital environment.
Surge
IEC 61000-4-5
± 1 kV differential
mode
± 2 kV common
mode
± 1 kV
differential
mode ± 2 kV
common mode
Mains power quality
should be that of a
typical commercial or
hospital environment.
Voltage dips,
short
interruptions
and voltage
variations on
power supply
input lines IEC
61000-4-11
<5 % UT (>95 % dip
in UT) for 0,5 cycle
40 % UT (60 % dip in
U
T
) for 5 cycles
70 % UT (30 % dip in
U
T
) for 25 cycles
<5 % UT (>95 % dip
in UT) for 5sec
>95 % dip for
10 ms
60 % dip for
100 ms
30 % dip for
500 ms
95 % dip for
5000 ms
Mains power quality
should be that of a
typical commercial or
hospital environment. If
the user of the device
requires continued
operation during power
mains interruptions, it is
recommended that the
device be powered from
an uninterruptible
power supply.
Power frequency
(50/60 Hz)
magnetic field
IEC 61000-4-8
3 A/m
3 A/m
Power frequency magnetic
fields should be at levels
characteristic of a typical
location in a typical
commercial or hospital
environment.
NOTE - UT is the AC mains voltage prior to application of the test level.
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Section 13: System Specifications
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Guidance and manufacturer’s declaration – electromagnetic immunity
The System is intended for use in the electromagnetic environment specified below. The customer
or the user should assure that it is used in such an environment.
IMMUNITY
Test
IEC 60601
Test
Level
Compliance
Level
Electromagnetic environment – guidance
Conducted
RF IEC
61000-4-6
Radiated RF
IEC 610004-3
3 Vrms
150 kHz to
80 MHz
3 V/m
80 MHz to
2,5 GHz
[3] V
[3] V/m
Portable and mobile RF communications
equipment should be used no closer to any
part of the device, including cables, than the
recommended separation distance calculated
from the equation applicable to the
frequency of the transmitter.
Recommended separation distance
Where P is the maximum output power rating
of the transmitter in watts (W) according to
the transmitter manufacturer and d is the
recommended separation distance in meters
(m).
Field strengths from fixed RF transmitters, as
determined by an electromagnetic site
survey,a should be less than the compliance
level in each frequency range.b
Interference may occur in the vicinity of
equipment marked with the following
symbol:
NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is
affected by absorption and reflection from structures, objects and people.
a Field strengths from fixed transmitters, such as base stations for radio
(cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio
broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess
the electromagnetic environment due to fixed RF transmitters, an electromagnetic site
survey should be considered. If the measured field strength in the location in which the
System is used exceeds the applicable RF compliance level above, the System should be
observed to verify normal operation. If abnormal performance is observed, additional
measures may be necessary, such as re-orienting or relocating the System.
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b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
Recommended separation distances between
portable and mobile RF communications equipment and the System
The System is intended for use in an electromagnetic environment in which radiated RF
disturbances are controlled. The customer or the user of the System can help prevent
electromagnetic interference by maintaining a minimum distance between portable and
mobile RF communications equipment (transmitters) and the System as recommended
below, according to the maximum output power of the communications equipment.
Rated maximum output
power of transmitter
[W]
Separation distance according to frequency of transmitter [m]
150 kHz to 80 MHz
80 MHz to 800
MHz
800 MHz to 2,5
GHz
0,01
0.117
0.117
0.233
0,1
0.369
0.369
0.738
1
1.167
1.167
2.333
10
3.689
3.689
7.379
100
11.667
11.667
23.333
For transmitters rated at a maximum output power not listed above, the recommended
separation distance d in meters (m) can be estimated using the equation applicable to the
frequency of the transmitter, where P is the maximum output power rating of the
transmitter in watts (W) according to the transmitter manufacturer.
NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range
applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is
affected by absorption and reflection from structures, objects and people.
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Table from IEC60601-1-2, / 5.2.2.1 C&F
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