Operator Manual
InMode™ System
with LUMECCA™ 515 & 580
Handpiece
DO6022531B
InMode LUMECCA Operator Manual
0344
2
InMode™ System with LUMECCA™ 515 & 580 Handpieces
Operator Manual
DO6022531B
Copyright © InMODE MD Ltd,
Date: July 2012
All rights reserved. Contents of this publication may not be reproduced in any form
without the written permission of InMode MD Ltd.
M
InMODE MD Ltd
Tabor House, Industrial Park South
POB 44, Yokneam 2069201, Israel
For information call: +972-4-9096317
InMode LUMECCA Operator Manual
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Table of Contents
SECTION 1 - INTRODUCTION ................................................................................................................. 6
B
EFORE YOU START
S
YSTEM OVERVIEW
C
ONVENTIONS USED IN THE MANUAL
E
XPLANATION OF THE SYMBOLS USED ON THE SYSTEM
SECTION 2 - SAFETY ................................................................................................................................. 8
T
HE PATIENT
T
REATING ATTENDANT
C
AUTIONS
O
CULAR HAZARDS
O
CULAR SAFETY CONSIDERATIONS
E
LECTRICAL AND MECHANICAL SAFETY
F
IRE HAZARDS
S
AFETY FEATURES OF THE SYSTEM
A
CTIVE ACCESSORY
W
ARNINGS
D
EVICE LABELS
................................................................................................................................................... 9
................................................................................................................................................12
................................................................................................................................... 6
.................................................................................................................................... 6
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............................................................................. 7
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H
AND PIECES LABELS
E
QUIPMENT CLASSIFICATION
SECTION 3 - SYSTEM INSTALLATION ............................................................................................... 17
E
LECTRICAL REQUIREMENTS
E
NVIRONMENTAL REQUIREMENTS
E
QUIPMENT LIST
U
NPACKING
I
NSTALLATION
F
ILLING WATER
M
OVING THE SYSTEM
D
ISPOSAL OF SYSTEM
SECTION 4 – DEVICE DESCRIPTION .................................................................................................. 21
R
EAR PANEL
F
RONT PANEL AND OPERATOR CONTROL PANEL
S
OFTWARE SCREENS
F
UNCTIONAL KEYS
S
OUND INDICATOR
...............................................................................................................................................18
..............................................................................................................................................21
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....................................................................................................................................26
H
ANDPIECES
SECTION 5 - SYSTEM OPERATION ..................................................................................................... 28
D
EVICE START-UP
InMode LUMECCA Operator Manual
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.....................................................................................................................................28
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S
YSTEM SHUTDOWN
..................................................................................................................................28
SECTION 6 - TREATMENT INFORMATION....................................................................................... 29
I
NDICATIONS FOR USE
W
ARNINGS
P
OSSIBLE SIDE EFFECTS
PRE-
T
IP CLEANING INSTRUCTIONS PRIOR TO USE
T
REATMENT RECOMMENDATIONS
T
REATMENT SCHEDULE
P
OST TREATMENT RECOMMENDATIONS
SECTION 7 – SYSTEM MAINTENANCE .............................................................................................. 33
E
XTERNAL VALIDATION MODULE
F
ILLING WATER
D
RAINING WATER
C
LEANING THE DEVICE
SECTION 8 - TROUBLESHOOTING ...................................................................................................... 37
D
ESCRIPTION OF FAULTS
SECTION 9 - SYSTEM SPECIFICATIONS ............................................................................................ 39
................................................................................................................................................29
TREATMENT RECOMMENDATIONS
...............................................................................................................................29
............................................................................................................................30
......................................................................................................30
............................................................................................31
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.....................................................................................................................................35
.............................................................................................................................36
...........................................................................................................................37
EMC S
T
ABLE FROM
AFETY FOR THE INMODE DEVICE
IEC60601-1-2, / 5.2.2.1 C&F................................................................................................44
...................................................................................................40
InMode LUMECCA Operator Manual
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Section 1 - Introduction
Before You Start
The manual and the equipment it describes are for use only by qualified medical
professionals trained in the particular technique to be performed.
Federal (USA) law restricts sale of this device to, or on the order of a physician.
Read this manual to become familiar with all safety requirements and operating
procedures before attempting to operate the System.
System Overview
The InMode LUMECCA is a computerized system generating Intense Pulsed Light (IPL)
which is applied to the skin for selective treatment superficial vascular and pigmented
lesions. Light energy is selectively absorbed by melanin and hemoglobin creating
coagulation of lesion structure.
The System provides individual adjustment of light fluence and pulse duration to achieve
maximum efficiency and safety for each patient. Two handpieces can be attached to the
system where one Handpiece has a filter of 515 nm and is used on light skin treatment
and a second Handpiece with 580nm filter for use on darker skin.
The System provides enhanced safety and patient comfort while minimizing possible side
effects by cooling skin surface during the treatment.
Conventions Used in the Manual
The following conventions in the form of notes and warnings are used in this manual:
Provides general information that is important to keep in mind.
WARNING: This information is extremely important.
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Explanation of the Symbols used on the System
Symbol Description
Warning!
Attention! Consult Accompanying Document
CSA marking (212603 CSA master contract number)
CE marking
Do not discard in trash. Electronic equipment should
be disposed of in an appropriate manner
Fuse
Type B Equipment.
Follow operating instructions
Note
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Section 2 - Safety
This chapter describes safety issues regarding the use and maintenance of the System,
with a special emphasis on electrical and optical 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 chapter.
The primary consideration should be to maximize safety for both treating attendant and
patient.
• Read this chapter to be familiar with all its safety requirements
and operating procedures prior to System operation.
• IPL devices can cause injury if used improperly.
• High voltage is present inside the System.
• Always be aware of the possible dangers and take proper
safeguards as described in the manual.
The Patient
Well-trained staff is a key for assuring patient safety. A patient history should be
completed prior to scheduling. Patients should be fully informed of the treatment
protocol, the likely results and any risks associated with the treatment.
Jewelry and metal accessories should be removed to avoid accidental light reflection.
Protective eyewear must be used during the treatment.
Treating Attendant
Only authorized individuals with appropriate training and knowledge should operate,
assist in the operation of, or provide maintenance to the InMode System with the
LUMECCA Handpiece.
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.
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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 personnell only.
To avoid damage, do not allow the Handpiece to come in contact with hard
materials.
Ocular hazards
The light emitted by the LUMECCA Handpiece is capable of causing eye irritation or
damage.
All persons potentially subject to exposure must wear protective goggles or eyewear in
accordance with national and international standards. The protective eyewear must have
an optical density (OD) of 5 or greater at the LUMECCA wavelength of –515-1200 nm.
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 IPL is 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 room must be covered with opaque
material, and measures should be taken to prevent unauthorized access to the room.. In
addition, compliance with IEC 60601-2-57 requires that warning label from IR exposure
be posted at all entrances whenever the IPL is in use. An approved sign is provided with
each system along with protective eyewear. Additional eyewear or safety signs may be
obtained from the manufacturer.
All persons potentially subject to IPL exposure must wear appropriate eye protection
whenever the main power is on.
Never look directly into the light output 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 beam anywhere other than the calibration port or intended treatment
area. Stray light and reflection is always a potential hazard and may cause serious injury.
Do not treat eyelids or other areas within the bony area surrounding the orbit. The light
emitted by the LUMECCA IPL is capable of causing serious eye damage.
Ocular safety considerations
• Identify the treatment room clearly by posting approved safety signs in prominent locations.
• Cover all windows to prevent light from escaping the treatment room.
• Restrict entry to the treatment room when IPL is in use. Allow access to those personnel
both essential to the procedure and well trained in safety issues.
• Never direct the IPL beam at anything other than the calibration port or the intended
treatment site.
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• Never look directly into the IPL light guide at the distal end of the Handpiece.
• All persons in the treatment room must wear approved safety eyewear with an optical
density of 5 or greater at the InMode LUMECCA wavelength of –515-1200 nm. 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. This includes the operator, patient, nurses,
and any other persons in the room.
• Do not attempt to remove the protective covers on the Handpiece, which could allow
exposure to high intensity light.
Electrical and Mechanical Safety
Keep all covers and panels of the System closed. Removing the covers creates a safety
hazard.
Keep hands away from the applicator during the System start-up.
Perform maintenance procedures when the System is shut down and disconnected from
the power.
The System is grounded through the grounding conductor in the power cable. This
protective grounding is essential for safe operation.
Move the System slowly and carefully. The System weighs approximately 25kg (55lb.)
and may cause injury if proper care is not used when moving it.
Fire Hazards
The absorption of the IPL energy raises the temperature of the absorbing material. Do
not use the System in the presence of explosive or flammable materials.
Keep drapes and towels moist to prevent them from igniting and burning. Use non-
flammable prepping solutions.
Do not use flammable substances when preparing the skin for treatment. Be especially
careful with the use of oxygen.
If alcohol is used for cleaning and disinfecting, it must be allowed to dry thoroughly
before the System is used.
Safety Features of the System
The System incorporates the following safety features. All personnel operating the
System should be familiar with these features.
System has unique password to avoid device operation by not authorized personnel.
An audible tone indicates energy activation.
The power electronics cannot be activated unless the applicator has been connected to
the System.
During activation, the System performs a self-test of the hardware.
Hardware is tested every 10ms to ensure proper operation of electrical circuit.
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System starts at a low power setting.
Active accessory
Examine the Handpiece and 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 Handpiece output window on other treatment attendants or on are that
intended to be treated.
• Do not connect a wet accessory to the System.
• Do not immerse the applicator under water at any time.
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Warnings
This equipment is for use only by trained, licensed physicians.
Only handpieces manufactured or approved by InMODE MD Ltd. should be used with
InMode System.
Connect the power cord to a properly polarized and grounded power source with the
frequency and voltage characteristics that match those listed on the back of the unit.
Connect the 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 system use.
Use the lowest output setting necessary to achieve the desired treatment effect. The higher
optical energy is applied, the greater the possibility of unintended thermal damage of skin.
The cables of the Handpieces should be positioned in such a way that contact with the
PATIENT or other leads is avoided.
Fire / Explosion Hazard - The following substances will contribute to increased fire and
explosion hazards in the operating room:
The IPL and heating associated with the System can provide an ignition source. Observe
fire precautions at all times.
substances or gases, prevent their accumulation or pooling within the area where
InMode procedures are performed.
• Flammable substances (such as alcohol based skin prepping agents and tinctures).
• Naturally occurring flammable gases which may accumulate in body cavities such as
the bowel.
• Oxygen enriched atmospheres.
• Oxidizing agents (such as nitrous oxide [N2O] atmospheres).
• Endogenous gases.
When using InMode in the same room with any of these
The operation of the IPL 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.
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Device Labels
The following device labels are located on the back panel of the InMode device
Figure 2.1 System Certification and identification label
Figure 2.2 Emergency STOP label
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Figure 2.3 IPL warning label
Figure 2.4 IPL emission warning label
Figure 2.5 IPL footswitch label
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Hand pieces labels
Figure s 2.5 and 2.6 shows the labels affixed to the IPL handpieces
Figure 2.6 LUMECCA 515 Handpiece identification label
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Figure 2.7 LUMECCA 580 Handpiece identification label
These certification and identification labels are attached to connectors on the Handpiece.
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.
There are two models of Handpiece: LUMECCA515 with 515nm filer for light skin
treatment and LUMECCA580 with 580nm filer for darker skin.
Equipment Classification
The following is a list of the different equipment used and their classifications.
Electric shock protection: Class I, Defibrillation-proof Type B.
Protection against ingress of liquids: Ordinary equipment.
Not suitable for use in presence of flammable substance.
The InMode System with LUMECCA handpieces is classified as IIa device defined
by the Medical Device Directive (93/42/EEC) for CE marking.
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Section 3 - System Installation
Electrical Requirements
The System will require a separate line supply of single phase (100Vac; 15A) or
(115Vac; 15A) or (230Vac; 15A) or (240Vac; 15A) 50-60Hz.
Power receptacles must be within 15 feet of the System site.
The System should not share a power line with other equipment.
For continued protection against fire, replace the fuse only with
one of the same type and rating.
Proper grounding is essential for safe operation.
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%.
Equipment List
The System includes the following:
System platform.
LUMECCA 515 & 580 Handpieces.
LUMECCA Handpiece cradle.
Operator manual.
Power cord.
User protective goggles.
Patient eyewear.
Power meter.
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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 device out of the box using top and bottom handles.
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Installation
The System is designed for installation in a clinic environment. To install the System
perform the following tasks:
Check the System and all its components for damage.
Connect cradle to the deice (Fig. 3.1).
Connect Handpiece to the connector on front panel (Fig 4.1).
Place Handpiece 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
Filling Water
InMode system 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 7 – System Maintenance.
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Moving the System
To move the System:
Turn the System off.
Disconnect the Power Cord.
Disconnect the Handpieces.
Disconnect the footswitch.
Release the wheel brakes.
Slowly push or pull the System using the handle.
When moving to another facility, lift the System to the vehicle and lay it carefully on
its side.
For shipment, drain the water from the system and the hanspieces, as described in
Section 7- 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).
Disposal of System
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
Rear Panel
Power cord inlet
!!
100-240V~, 15A, 50-60Hz.
Fuse holder
Rating is T 15A, 250V. Replace fuse if it is needed only with fuses having
exactly the same rating.
Software flash memory plug
Software plug is a flash memory with the machine software. The software
plug should be screwed to the connectors.
Foot switch connector
Foot switch is connected to the inlet. Foot switch may activate IPL energy
if the system is in Ready mode, as an alternative to the hand trigger. Place
the foot switch on the floor near the treatment area.
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Emergency Stop Button
Front Panel and Operator Control Panel
The Operator Control Panel is located on the upper side of the System. The Operator
Control Panel consists of an LCD screen with four buttons.
On the front panel there is a grey On/Off switch on the left and a red Emergency Stop
Button on the right and a Handpiece connector in the center.
Figure 4.1 Operator Control Panel
Power On-Off switch
Handpiece connector
LCD screen
Power electronics is not activated if no Handpiece is connected to its connector on the
front or the rear panel.
Power switch turns power electronics off.
Power electronics is not activated if Handpiece is not
connected to connector.
Stops the power instantly in emergency conditions.
LCD screen shows information about system mode
and treatment parameters.
The panel allows changing treatment parameters and
system mode.
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Software Screens
The Splash screen appears after the On-Off switch is turned on.
Figure 4.2 Splash Screen.
*The version number will be displayed according to the software version.
After entering the individual code in the Login screen, non-authorized use of the device is
prevented.
Figure 4.3 Login Screen
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.
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Figure 4.4 Menu Screen.
Menu Screen allows selection of connected Handpiece or entering Maintenance Screen.
Figure 4.2 Maintenance Screen
Maintenance screen allows:
• Drain water from the Handpiece and device prior to shipment and fill water during
installation.
• External validation module for LUMECCA Handpiece.
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After choosing the application the corresponding Treatment Screen appears.
Figure 4.6 LUMECCA 515 Treatment Screen
Fluence
Pulse width
Cooling
Pulse Counter
Repeat Mode
Fluence (light energy density) is changed within the limits allowed
for the connected handpiece. Fluence delivered during one pulse is
changed from 5 to 30 J/cm2 and the System starts up at the minimal
energy setting.
Short or Long pulse can be selected.
Normal and Strong cooling can be selected.
Shows number of pulses delivered from the beginning of the
treatment. Counter can be reset.
Repeat mode or single pulse mode can be selected.
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System Mode
Functional Keys
The System has two treatment modes.
Standby mode allows the user to set treatment parameters.
Activation of energy is not allowed in Standby mode.
In Ready mode, 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.
During transition between STANDBY and READY, the system
checks the voltage of the energy-storage capacitors.
When the voltage is too high, while moving from high to low
fluence, DISCHARGING message will appear on the screen until
voltage stabilizes.
When the voltage is too low, CHARGING message will appear on
the screen until voltage stabilizes.
During CHARGING and DISCHARGING period, which may last
a couple of seconds, IPL pulse delivery is not possible. This delay
is not a malfunction but a normal way of system operation.
Shift
This sign indicates the functional key allowing the user to select the
treatment parameters.
Up
This sign indicates the functional key allowing the user to increase the
selected treatment parameter.
Down
This sign indicates the functional key allowing the user to decrease the
selected treatment parameter.
Mode
This sign indicates the functional key allowing the user to change the
System Mode.
Sound Indicator
Periodic beeping signal is emitted when a pulse is delivered.
Warning sound tone indicates Bad Coupling.
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Handpieces
Each of the InMode LUMECCA Handpiece comprises applicator, cable and connector.
Applicator
Cable
Connector
Figure 4.7 Handpiece
Comprises flash lamp and reflector emitting optical energy
through the pre-cooled light guide (30x10 mm).
Has a length of 170cm.
Is connected to the system.
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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 the
light guide for cleanliness and possible mechanical damage.
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 LUMECCA application from the Menu Screen and System will enter the
Treatment Screen.
7. Verify on the screen that Software version is properly displayed and connected
Handpiece type is recognized correctly.
8. Select treatment parameters.
9. Select Ready mode to confirm the selected parameters. The System is ready for
pulsing.
10. Select treatment parameters using UP and DOWN keys:
11. Select READY mode to confirm the selected parameters.
12. The System is ready for use. Press trigger button on handpiece or footswitch.
System Shutdown
To shut down the System turn the power switches off.
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 - Treatment Information
InMode LUMECCA treatment is based on principles of selective photothermolisys. 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. Multiple treatment sessions may be required for best results.
Indications for Use
The InMode System with the LUMECCA Handpieces is intended for treatment of
superficial vascular and pigmented lesions on skin type I-IV.
Warnings
Avoid treatment or proceed with caution in the following cases:
• 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 or thyroid dysfunction.
• 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.
• 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 such as light, laser or
RF were performed on treated area.
• Vitiligo.
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• 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.
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 are 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.
• Do not treat the upper eyelids and the lips!
• Do not treat over tattoo and permanent makeup!
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.
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Patient may shave the area to be treated. Long and dark hairs may absorb
light and leave burn mark on the skin.
Tip Cleaning Instructions Prior to Use
Clean the light guide with 70% alcohol absorbed pad.
Leave it for complete drying.
Treatment Recommendations
1. Follow Device Start-Up Procedure from System Operation section.
2. Ensure that skin is clean.
3. Apply thin layer of water based gel to the treated area.
4. Set treatment parameters. Typical treatment parameters are shown in the table
below:
Skin type Lesions type Handpiece
(nm)
I-II
III-V
Pigmented
lesions
Vascular
lesions
Pigmented
lesions
Vascular
lesions
515 8-12 Short Normal/Strong
515 12-16 Short Normal/Strong
580 6-12 Short Strong
580 10-16 Long Strong
Fluence
(J/cm2)
Pulse width Cooling
5. Always start with a low settings level to check patient tolerance to the treatment
parameters and then gradually increase energy fluence to reach the results.
6. Apply Handpiece to the treated area ensuring a contact with slight pressure, and
press trigger button to deliver light pulse.
7. In a single mode (AutoRepeat Off) - move Handpiece by stamping to adjacent
area without overlap and apply next pulse to cover all treatment area.
8. In a continuous mode - slide the Handpiece to adjacent area without overlap and
chose Auto Repeat Normal or Fast Mode according to the speed of your hand
movement.
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Treatment schedule
• The number of treatments is typically varied from 3-5 sessions every three
weeks.
• Treatment should be concluded when the results are satisfactory to the patient or
according to the physician's discretion.
Post treatment recommendations
After each treatment session, the physician should advise the patient on proper care.
Sun block should be used for 3 week following the treatment.
Moisturizer may be applied after each treatment.
Make-up may be applied immediately after the treatment.
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Section 7 – System Maintenance
External Validation Module
Energy calibration is needed for the optical Handpieces only. It is needed to determine the
relationship between electrical and optical parameters and verifies that the laser/IPL
energy is within the required range. The procedure consists of measuring the output
energy of the laser/IPL with an energy meter connected to the calibration port, as
described in the instructions below. The microcontroller automatically sets the laser /IPL
parameters over the operating range, determining the electrical parameters, and
comparing the measured parameters, and compares the measured and expected pulse
energies. Monthly validation is recommended.
To perform the calibration on maintenance screen by authorized technician once a year:
• Choose 30J/cm2 and short pulse.
• Ensure that the Handpiece sapphire output window and energy meter window
are clean and free of condensed water, for accurate energy calibration.
• Insert the sapphire output window of the Handpiece carefully into the calibration
device. The window must be pointing downward the energy meter and the
Handpiece fully seated in its place.
• Press the footswitch and Handpiece trigger.
• The measured energy should be between 96J and 144J. If measured energy is
out of range, clean the Handpiece window and repeat the test. If after cleaning
the energy is still out of range, call service.
Filling Water
InMode systems, DIOLAZE and LUMECCA handpieces are shipped without water.
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).
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Figure 11.1 Figure 11.2
4. Unscrew the filter on the side of the plastic cap counterclockwise to release air.
Afterwards, screw the cap clockwise to close it.
Figure 11.3
5. Ensure that no water is leaking.
6. Fill the bottle up to the maximum level.
7. Close the cork and insert the bottle at the back of the system.
8. Connect a LUMECCA 515 or 580 hand piece. It is important NOT to connect
the DIOLAZE first on the initial water filling since this can cause air bubbles to
form, resulting in the system to display “Water Flow Error”.
9. Turn the system ON.
10. Select “Maintenance” on the main menu and press the green check button (Figure
11.4).
11. Select “Water Fill/Drain” and press the green check button (Figure 11.5).
12. The display will count down from 180 seconds (3 minutes) to 0 seconds. The
pump current should be between 0.60 – 0.75A (Figure 11.6).
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Figure 11.4 Figure 11.5 Figure 11.6
13. Selecting “Exit” and pressing the green check button will stop the water pump.
14. Turn the system OFF.
15. Repeat Steps 2 to 7 since the system and handpiece will take some of the water.
16. Connect the Diolaze.
17. Repeat Steps 8 to 14.
18. If additional Lumecca/Diolaze are present, connect each handpiece and repeat
Steps 8 to 15. Ensure the water level is checked periodically.
Draining Water
For shipping and storage, the InMode systems and 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 11.7).
Figure 11.7 Figure 11.8
3. Empty the bottle.
4. Place the bottle inside the chamber with the black hose outside the bottle (Figure 11.8).
5. Connect any Lumecca or Diolaze handpiece.
6. Turn the system ON.
7. Select “Maintenance” on the main menu and press the green check button (Figure 11.4).
8. Select “Water Fill/Drain” and press the green check button (Figure 11.5).
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9. The display will count down from 180 seconds (3 minutes) to 0 seconds (Figure 11.6).
10. Selecting “Exit” and pressing the green check button will stop the water pump.
11. Repeat Steps 5 to 9 for the any remaining Lumecca or Diolaze handpiece.
Cleaning the Device
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 after removal of the
residual gel.
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Section 8 - Troubleshooting
The InMode System with the LUMECCA Handpiece provides monitoring of all critical
parameters to ensure safety of patient and user. If any of the following faults are detected
system automatically goes to STAND BY mode.
Description of Faults
System did not turn on
• Check power cord connection.
• Check that main switch on rear panel is on.
• Check fuses on back panel of the System.
• Call Technical Service if problem persists.
Software plug missing
• The software plug is not inserted.
Checksum
• The software was not loaded properly from software plug.
• Check plug connection and reboot the System.
• Call Technical Service if problem persists.
Fault H8002 - Handpiece is not connected
• Check connection of Handpiece.
• Replace Handpiece.
• Call Technical Service if problem persists.
Fault H8005 – System Memory Fault
• Call Technical Service if problem persists.
Fault H8601 – Distributor Card Connection Fault
• Call Technical Service if problem persists
Fault H8609 – Water Temperature Fault
• Call Technical Service if problem persists
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Fault H860B – Water Flow Fault
• Call Technical Service if problem persists
IPL Related Faults – H8401, H8410, H8420, H8421, H8422, H8430, H8431
• Call Technical Service if problem persists
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Section 9 - System Specifications
Input Power
Main Line Frequency (nominal)
Input Voltage (nominal)
Input Current (rms)
Operating Parameters
Ambient Temperature Range
Relative Humidity
Atmospheric Pressure
Warm-up Time
Transport and Storage
Ambient Temperature Range
Relative Humidity
Atmospheric Pressure
Dimensions
System
Handpiece cable
50-60 Hz
100-240 VAC
12A,
15° – 35° C [59° – 95° F]
30% to 80%, non-condensing
90-110kPa
If transported or stored at temperatures outside the operating
temperature range, allow one hour for the system to reach room
temperature before use.
-20° – 65° C [35° – 131° F]
0% to 80%, non-condensing
50-110 kPa
46cm W x 46cm D x 100cm H
170 cm L
[18.2’’ W x 18.2’’ D x 40’’ H]
[67`` L]
Weight
System
Applicator
Output Parameters
Spectrum
Fluence
Light guide cooling
Spot size
25 Kg
0.45 Kg
515-1200nm
580-1200nm
10-30J/cm2
10-20oC
10 mm x 30 mm
[55 lbs.]
[1 lbs.]
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EMC Safety for the InMode Device
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 Invasix 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.
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.
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Guidance and manufacturer’s declaration – electromagnetic emissions
The InMode is intended for use in the electromagnetic environment specified below. The customer or the user of
the InMode should assure that it is used in such an environment.
Emissions test Compliance
RF emissions CISPR 11 Group 1 The InMode uses RF energy only for its internal
RF emissions CISPR 11 Class B The InMode is suitable for use in all
Harmonic emissions
IEC 61000-3-2
Voltage fluctuations/ flicker
emissions IEC 61000-3-3
Not Applicable
Complies
Guidance and manufacturer’s declaration – electromagnetic immunity
The InMode is intended for use in the electromagnetic environment specified below. The customer or the user of
the InMode should assure that it is used in such an environment.
Immunity test IEC 60601 test level Compliance level Electromagnetic environment
Electrostatic
discharge (ESD) IEC
61000-4-2
Electrical fast
transient/burst
IEC 61000-4-4
Surge IEC 61000-4-5 ± 1 kV differential mode
Voltage dips, short
interruptions and
voltage variations on
power supply input
lines IEC 61000-4-11
Power frequency
(50/60 Hz) magnetic
field IEC 61000-4-8
NOTE - UT is the AC mains voltage prior to application of the test level.
± 6 kV contact
± 8 kV air
± 2 kV for power supply
lines ± 1 kV for
input/output lines
± 2 kV common mode
<5 % UT (>95 % dip in
UT) for 0,5 cycle
40 % UT (60 % dip in UT)
for 5 cycles
70 % UT (30 % dip in UT)
for 25 cycles
<5 % UT (>95 % dip in
UT) for 5 sec
3 A/m 3 A/m Power frequency magnetic fields
Electromagnetic environment – guidance
function. Therefore, its RF emissions are very low
and are not likely to cause any interference in
nearby electronic equipment.
establishments other than domestic and those
directly connected to the public low-voltage power
supply network that supplies buildings used for
domestic purposes.
– guidance
± 6 kV contact
± 8 kV air
± 2 kV for power
supply lines
± 1 kV differential
mode ± 2 kV common
mode
>95 % dip for 10 ms
60 % dip for 100 ms
30 % dip for 500 ms
95 % dip for 5000 ms
Floors should be wood, concrete
or ceramic tile. If floors are
covered with synthetic material,
the relative humidity should be at
least 30 %.
Mains power quality should be
that of a typical commercial or
hospital environment.
Mains power quality should be
that of a typical commercial or
hospital environment. If the user
of the InMode requires continued
operation during power mains
interruptions, it is recommended
that the InMode be powered
from an uninterruptible power
supply.
should be at levels characteristic
of a typical location in a typical
commercial or hospital
environment.
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Guidance and manufacturer’s declaration – electromagnetic immunity
The InMode is intended for use in the electromagnetic environment specified below. The customer or the user
of the InMode 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 61000-4-3
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 InMode,
including cables, than the recommended separation
distance calculated from the equation applicable to the
frequency of the transmitter.
Recommended separation distance
3,5
√
3,5
√
80800
7
√
802,5
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:
3,5
√65 .
3
3,5
√65 .
3
7
√65 .
3
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 InMode is used exceeds the applicable RF compliance level above, the InMode should be observed to
verify normal operation. If abnormal performance is observed, additional measures may be necessary,
such as re-orienting or relocating the InMode.
b
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
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3,5
√
3,5
√
7
√
Recommended separation distances between
portable and mobile RF communications equipment and the
The InMode is intended for use in an electromagnetic environment in which radiated RF disturbances are
controlled. The customer or the user of the InMode can help prevent electromagnetic interference by
maintaining a minimum distance between portable and mobile RF communications equipment
(transmitters) and the InMode as recommended below, according to the maximum output power of the
communications equipment.
Rated maximum output
power of transmitter [W]
0,01
0,1
1
10
100
Separation distance according to frequency of transmitter [m]
150 kHz to 80 MHz
0.117 0.117 0.233
0.369 0.369 0.738
1.167 1.167 2.333
3.689 3.689 7.379
11.667 11.667 23.333
80 MHz to 800 MHz
InMode
800 MHz to 2,5 GHz
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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